Son stabs mother to give ‘freedom from life’ – Deccan Herald

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A 45-year-old woman was stabbed five times by her son in South Delhis Madnagirarea on Monday morning, multiple news outlets reported.

The accused, identified as Sagar (22), said that he killed her to give her freedom from life, the police said. He was found next to his mothers body. The five stab wounds bled profusely which ultimately led to her death.

Investigating officials said that Sagar was chanting Aaj maine apni ma ko mukti de di ho (Today, I gave freedom to my mother) when asked about the incident. He also gave inconsistent replies.

Even during questioning, he has been talking about life after death and philosophy and has given vague answers. We suspect he has hallucination issues, the officer toldTimes of India. It was also revealed that he was addicted to drugs and alcohol and consumed them on a daily basis. He worked as a DJ in a caf in Hauz Khas, Delhi.

After hearing screams from the apartment, the neighbours called the police at around 11.30 in the morning on Monday.

The woman, Anjali Francis, lived with her son in G-block, an area close to Madnagir central market.

The police said that they are consulting a psychologist and are also probing to see if the accused was following any godman.

Atul Kumar Thakur, DCP, said, A case of murder has been registered and the accused has beenarrested. The murder weapona kitchen knifewas also seized from the house. Further investigations are underway.

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Son stabs mother to give 'freedom from life' - Deccan Herald

The idea of freedom – The Express Tribune

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Article 19 of the Human Right declaration acknowledges that everyone has right to seek, receive and impart information through any medium without being worried about the consequences. The chief theorist that brought to light the importance of freedom of expression was the 19th century British liberal thinker Jaun Staurt Mill. He argued that the only way society can progress is by letting human beings express their opinions and views freely. Moreover, he said that the West transformed itself into the leading civilisation of the world because of freedom of expression, which underpinned freedom of enquiry thus paving the way for scientific research and discoveries.

While freedom of speech may have its own disadvantages, the benefits far outweigh them. Firstly, freedom of speech plays vital role in the creation of tolerant and pluralistic society, which ensures that people of different colour, creed, class, sects and religion can all coexist peacefully. Secondly, freedom of expression also plays a crucial role in developing democracy as it is the backbone of a democratic state. It can allow the common man to pressurise the government and concerned authorities to work for the welfare of society instead of their own self interests. Thirdly, freedom of expression helps enhancing accountability. Accountability is another key tenet of democracy that seeks to hold leaders, individual and policymakers accountable for their decision by acknowledging that states that no institutions or individual is above than law. Lastly, freedom of expression also helps to get rid of evils in society. No social evils can be eliminated until and unless the people have the power to speak up against malpractices.

It is important to ponder on the idea of freedom as it is at the very heart of society and human nature. Governments and international communities around the world need to make a collaborative effort to ensure the right to freedom in order to create for a better society for all.

Bilawal Ali Lakho

Shikarpur

Published in The Express Tribune, July 21st, 2020.

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The idea of freedom - The Express Tribune

Albanian Government Accused of Ignoring Freedom of Information Requests about COVID-19 Pandemic – Exit – Explain Albania

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The Albanian government and the Ministry of Health have been accused of blocking freedom of information requests relating to the expenditure of dealing with the COVID-19 pandemic.

Faktoje wrote that they have sent a number of requests to the Ministry as per the law On the right to information. The information they requested included how money has been spent during the pandemic.

Since March, a total of 37 tenders have been announced with a value of 1,020,843,731 ALL, The Ministry has spent some 324,516,849 so far but has not been forthcoming with information on details. The Ministry has not made public any details of the procurement policy, value per item, quality, quantity, or origin,.

In addition to this, the state budget has been reviewed a total of three times within six months. On each occasion, the Ministry was allocated funds to assist with the front line effort.

Despite continuous requests from the media, the Ministry has refused to give any information related to the pandemic, including tenders, financial information and the capacity to deal with the pandemic.

The right to information is protected under Albanian law 119-2014. The government is obliged to respond to the request within a certain timeframe. If the request is refused, they are required to notify the applicant and the applicant can then appeal the decision in court. Ignoring requests is against the law.

In terms of government aid given to Albanian businesses to manage the fall out of the pandemic and lockdown, the majority of it has been handed out to the countries biggest businesses and richest businessmen. An investigation by BIRN found that some 1.9 billion lek (EUR 15.3 million) went to ten of Albanias biggest firms. Most of these have been previous beneficiaries of concessionary agreements with the Rama government.

Beneficiaries included American Hospital, recipient of a government PPP, Albchrome which is owned by Albanias richest man Samir Mane, and Shefqet Kastrati one of the countries most notorious businessmen.

Fjal kye: Albania, coronavirus, corruption, covid-19, Tirana

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Albanian Government Accused of Ignoring Freedom of Information Requests about COVID-19 Pandemic - Exit - Explain Albania

Long Beach issues curfew on beaches, boardwalks; non-resident passes limited to weekdays only – WPIX 11 New York

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LONG BEACH, N.Y. Authorities in Nassau County are cracking down on Long Beach following a rowdy weekend of hundreds of beachgoers who weren't following pandemic rules.

Some residents said the crowds were young adults who were drinking and gathering in large crowds.

A curfew has been set for the beaches on Long Beach. Beaches will now close at 8:00 p.m., and the boardwalk will shut down an hour later, at 9:00 pm., according to police.

The curfew begins on Thursday.

The city is also limiting the sale of non-resident daily passes to weekdays only.

Meaning, if you don't live on Long Beach, you won't be able to come to the beach on the weekend.

Riptides owner Brian Braddish said people need to follow the rules or everyone, including his business, will be penalized.

Closing the boardwalk at 9:00 would be a good thing because theres been issues, and police presence is a good thing. Not having out-of-town residents here is going to hurt my business and hurt the revenue for Long Beach, said Braddish.

The measures are in place to keep the people safe.

The new hours will last until further notice.

The City Council is expected to discuss more about the new hours Tuesday night.

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Long Beach issues curfew on beaches, boardwalks; non-resident passes limited to weekdays only - WPIX 11 New York

Vacationers Enjoy Beaches in Blazing Temps – OCNJ Daily

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By MADDY VITALE

A furnace or a stove were some of the descriptors for the scorching air as temperatures soared into the high 90s at the shore Monday afternoon.

George Groves, of Bensalem, Pa., simply put it like this, hot, as he swooshed and coasted on his skim board alongside his son, Jeff, and his 17-year-old grandson, John, along the waters edge on the 34th Street Beach.

The family of 14 rented homes for the week in Ocean City and spent their Monday enjoying the 75-degree ocean temps and some breezes.

Its a really hot day at the beach, but in the water its great, George Groves said.

Like the Groves crew, other beachgoers clung to the shore line, just above where their beach gear would get soaked, for some relief from the sweltering heat.

Stephanie Sokorai, of Shamong, N.J., her five children, her sister, Jennifer Cipparone, and her three children, took to the ocean without hesitation.

We have been coming down to Ocean City for vacation for 16 years, Stephanie noted.

But Monday was memorable for high temps, she acknowledged.

And being near or in the water was the only smart thing to do, she said.

Sokorai summed up the feeling of being on the beach as opposed to being near the water.

A drastic difference. The heat is oppressive on the beach, she said.

Sokorais 14-year-old son, Declan, added to his mothers thoughts of the benefit of being near the ocean. The water feels cool, he said.

While vacationers took to the water to find relief, dipped their toes in or dove in, or sat near the ocean, others, like mother and daughter duo, Pat Shakin and Beth Vandusen, both of Egg Harbor Township, sat in the middle of the beach.

But they came prepared.

Sitting under a blue, flowered cabana that seemed to give just the right amount of protection from the blazing heat, the two, who have a summer home in Ocean City, noted that there was a cool breeze blowing perfectly under the cabana.

Its very breezy. It is very nice, Shakin said.

Vandusen added, We always bring it, but dont always put it up. But on a day like today, it went up.

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Vacationers Enjoy Beaches in Blazing Temps - OCNJ Daily

Summer Beach Project Adds Sand in OC | Government – Cape May County Herald

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OCEAN CITY At the north end of Ocean Citys Boardwalk, a small crowd gathered July 17 in the shadow of the Ocean City Beach Patrol headquarters to watch a beach be built.

Federal beach replenishment projects have become routine in the city since the first one, in the 1990s, which drew far larger crowds to watch the then-unusual project progress.

A large ocean-going dredge pumps water and sand from the shoals of the nearby inlet onto the beach, where crews use heavy equipment to shape a beach.

Before that first project, high tides slipped under the boardwalk daily, with little beach in the citys downtown.

Under a 50-year commitment, as part of that first project, the Army Corps of Engineers returned with a contracted dredging company several times to rebuild the beaches as they erode. The projects usually take place in the winter. This years project was set for spring, but repairs to the dredge delayed the start of the project until this month.

No one is happy about the work taking place during an already difficult summer, Mayor Jay Gillian told Ocean City Council, business leaders and others leading up to the work, but the city cant pass up the needed project, worth millions of dollars.

We need it, he told the council during a June meeting, held remotely. Weve gotten some emails about why do we do it in the summertime. We do it whenever we can when somebodys paying about 90% of it.

The dredge, owned by contractor Great Lakes Dredge, is now just outside the Great Egg Harbor Inlet, with steel pipes running along the beach. Orange netting and dune fencing blocks access to the project area, while piled sand allows beachgoers to cross the thick metal pipes through which the sand and water flow.

Visitors stop to watch a beach replenishment project underway, in Ocean City, adding sand to north end beaches. Officials usually try to avoid summer projects, but the Ocean City mayor said the project was needed, and this was when it could be accomplished.

According to the Army Corps of Engineers, the latest phase of the project will add sand from Morningside Road south to 13th Street, and then sand will be added between Morningside and Seaview roads.

The project area closes about 1,000 feet of beach at a time, with access preserved north and south of the project area.

The city has not heard any complaints about the work so far, said Ocean City spokesman Doug Bergen in a recent interview. He said the erosion in the project area is obvious so most visitors and residents can see the need for the work.

The project has not reached the busiest beaches along the Boardwalk, where hotels and businesses already report a difficult summer due to the pandemic. In other years, some visitors complained about the noise and disruption of the project on their block.

Just past the heavy equipment moving sand on the beach, lifeguards were on duty, and families played in the waves on an overcast morning.

According to the Army Corps posted timeline, the project will be completed by August. This is the ninth project pumping sand onto city beaches since the first one started, in October 1992.

The city has been emailing regular updates on the project for those who have signed up, including which beaches will be closed and how far the beach building progressed. According to the most recent update, the project will add 1.6 million cubic yards of sand to more than two miles of city beaches.

The contractor also will stockpile sand so the city can rebuild areas of dune to create an uninterrupted line across the length of the project area, reads a statement posted at ocnj.us/projectUpdate.

Beach replenishments for Strathmere and Sea Isle City were also completed, as part of the first phase of this project.

The total cost for this portion of the work is estimated at $16 million, with the cost divided between the federal government and the state, with the city contributing to the states costs. The city will be responsible for 12.5% of the total cost.

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Summer Beach Project Adds Sand in OC | Government - Cape May County Herald

Long Branch beach badges being resold by people leaving as access closed due to overcrowding – NJ.com

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People hoping to get on Long Branch beaches that were shut down due to crowding have resorted to purchasing badges from people headed home for the day, according to witnesses.

The badges are being sold at cost $7 by beachgoers as they depart, people in Long Branch told NJ Advance Media.

On Friday, officials said to expect beaches to close earlier and more frequently to allow visitors space to social distance. Then on Saturday, the city began charging to get on the beach at Plaza Court, Pullman Avenue, Park Avenue and Takanassee, which had been closed previously.

A few miles south, daily beach badge sales in Belmar were also suspended around 1 p.m. due to big crowds. Belmar officials previously said theyd limit daily sales to 7,500 per day.

Long Branch police couldnt immediately be reached.

Jeff Goldman may be reached at jeff_goldman@njadvancemedia.com. Follow him on Twitter @JeffSGoldman. Find NJ.com on Facebook.

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Long Branch beach badges being resold by people leaving as access closed due to overcrowding - NJ.com

Rise in coronavirus cases in Virginia fueled by spike near its beaches – Richmond.com

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Virginias eastern region, outlined by the states beaches, has seen an explosive spread of the coronavirus in recent weeks as trends for the rest of the state have seen slight upticks.

But as a slew of states to the south face devastating spikes in cases and new lockdowns, Virginias localized surge has prompted questions about how the state will avoid following suit.

State officials say the answer may lie in a regional approach to examining trends and levying public restrictions that they hope could stem surges early without reversing the states reopening.

That could mean more restrictions in eastern Virginia, where daily cases surged from an average of less than 100 a day to more than 400 a day in the past few weeks.

Virginia as a whole remains in the third and most relaxed phase of its reopening what may become the new normal until there is a vaccine or effective treatment, Gov. Ralph Northam suggested last week. There are no plans for a Phase Four.

Stricter restrictions and enforcement loom, however, if the trend of new cases doesnt hold flat.

I would do it regionally, if we make that decision. When all of this started, we made guidelines statewide, that was to flatten the curve, Northam said Tuesday in a briefing with reporters. Now its about mitigation, and depending on where thats needed, well direct those changes.

The Northam administration had in the spring rejected a regional approach to reopening, eventually relenting in the face of disparate trends in Northern Virginia and elsewhere. Now, with more testing, data and a better understanding of the virus, state and local health officials said breaking the state into five regions may be the right compromise between making blanket statewide rules or applying restrictions by locality.

The eastern region, which includes all of Hampton Roads, the Eastern Shore and more, has become the epicenter of the viruss surge in Virginia in recent weeks. There, health officials say, summer socializing coupled with the flouting of social distancing restrictions has disrupted a declining number of daily new cases.

The region has seen a precipitous increase in new cases that began over the last week of June. On June 26, the area matched its previous record for new cases reported in a day with 157, previously set on April 30. Over the last week, the seven-day average of new cases has continued to rise to more than 400 cases a day.

Part of the increase in new cases could be chalked up to increases in testing statewide, but not all. The region saw its peak on Wednesday at 526 cases, more than half of the 972 reported statewide.

Trends for hospitalizations have also risen in the region in recent days. Trends for deaths at the regional level remain steady in the eastern district and others. (The New York Times, citing its own analysis, reported Friday that additional testing in the U.S. may mean a bigger lag between a diagnosis, and hospitalizations and deaths.)

Todd Wagner, a health director in the eastern region, said the areas beaches and connected attractions have created an environment ripe for new cases, particularly among young people.

In his particular health district, Western Tidewater, which includes Suffolk and Southampton, Wagner said many outbreaks have been traced back to house parties and private social gatherings where one infected individual infected a broader group. Nearby outbreaks in the region could contribute to the frequency of those clusters, he said.

Wagner said his district fields visits by people traveling to and from the Outer Banks in North Carolina, another popular beach destination.

Theres a natural move toward the beach that happens every year in the summertime. When you go to the beach, theres closer proximity among people, than say, if you go to the mountains and hills of western Virginia, Wagner said.

You have whole rows of restaurants and bars. They dont have as much of that in the western part of the state, he added. Any time you have a setting like that, if restrictions arent properly followed, youve got a natural breeding ground for viral transmission.

The central region, which is anchored in the Richmond metro area, has seen an uptick in new cases this month. But the number of cases remains far below the areas peak in late May, when the area saw 279 cases reported in one day. The regions seven-day average of new cases was at 139 on Friday.

In the northern region, which includes Northern Virginia and is the smallest geographic region, new case trends have held steady and far below the regions explosive peak in late May. The areas seven-day average of new cases was 165 on Friday, compared to its peak of 685 cases on May 31.

The northwest region of the state which borders Hanover, reaches up to the border with West Virginia and down through Charlottesville has seen a slight uptick in cases over the past three weeks. Fridays seven-day average of new cases was 105 cases.

In the southwest region, which includes Roanoke down to Wise County, cases have been rising over the last week after an initial rise and fall at the end of June. The seven-day average of new cases was 98 on Friday.

All are trends officials continue to watch, said Stephens and Northam spokeswoman Alena Yarmosky.

Yarmosky did not rule out the possibility of future statewide restrictions, but said that better data will allow state and local officials to use target approaches to respond to surges. The shift is happening as localities debate the reopening of their schools in the fall.

Now that we have increased our capacity, the commonwealth has more options to deploy targeted mitigation strategies, she said, citing the work to contain outbreaks in poultry plants and stricter enforcement of restrictions at beach-area restaurants.

While this situation continues to be fluid and quickly changing, a regional mitigation approach gives us increased flexibility to address specific problems as they arrive.

Nicole Riley, state director of the National Federation of Independent Business, which represents many small businesses in the state, said the organization supports targeted enforcement and restrictions that allow as many businesses as possible to stay open.

We feel that the governor is now open to regionalism in a way, and at the end of the day, if thats the system we need for Virginias economy to be open, we support it, Riley said. But, with the caveat, that state government and localities still follow a transparent process.

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Rise in coronavirus cases in Virginia fueled by spike near its beaches - Richmond.com

Staten Islanders head to parks, beaches to beat the heat – SILive.com

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STATEN ISLAND, N.Y. -- Staten Islanders headed to the boroughs beaches and parks to cool off during the intense heatwave on Sunday.

The National Weather Service (NWS) issued a heat advisory Sunday, warning of heat index values up to 104 degrees.

The advisory is in effect until 8 p.m. on Monday, the NWS said.

The state Department of Environmental Conservation (DEC) and state Department of Health (DOH) issued an air quality health advisory Sunday, which is in effect until 11 p.m. Sunday.

Residents are encouraged to drink plenty of fluids, stay out of the sun, and reschedule events to early morning or evenings to avoid the heat, NWS says.

Despite the warnings, Wolfes Pond Park, Princes Bay and Conference House Park, Tottenville were buzzing with activity.

Large groups were seen on Sunday gathered at Wolfes Pond Park, with some grilling lunch and others sitting at tables. Many sunbathers sat on the beach or took a dip in the water.

In both parks, many people were seen using the shade to protect themselves from the sun.

One mom said that despite the warnings about the heat, the beach is the best way to stay cool.

I always go to the beach with my family on days like this. The water helps more than anything else, Yesenia Brown, Rossville mother-of-two, said.

Brown brings jugs of water with ice in them to keep her and her two sons cool as they sit on the beach.

Regularly applying sunscreen and bringing a beach umbrella are also key ways to stay safe, Brown said.

Its hot, but I dont want that to ruin [my kids] fun and their summer, she said. As long as we have sunscreen and some water, Im good to go.

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Staten Islanders head to parks, beaches to beat the heat - SILive.com

Bahamas Bans Flights From USA and Closes Beaches Due To Surge In Cases – Travel Off Path

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International commercial flights and commercial vessels will NOT be permitted except Canada, UK and EU effective Wednesday July 22nd at midnight

Bahamas Air will cease all outgoing flights to USA effective immediately.

ALL returning residents and visitors will require a negative test result within 10 days before departure day. The must also have an approved health visa to enter. Any resident who does not have a negative PCR test must be quarantined with a monitoring device for 14 days, or at a government facility at their expense. Covid-19 tests will be administered at the end of the 14-day quarantine at cost of traveler/resident.

Domestic travel will continue to be permitted, but all domestic travelers are still required to complete the electronic health visa.

Public and private beaches and parks on New Providence, Paradise Island, Grand Bahama and surrounding cays will be closed effective tomorrow at 5 p.m.

Restaurants at Arawak Cay and Potter's Cay will be closed effective tomorrow.

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Bahamas Bans Flights From USA and Closes Beaches Due To Surge In Cases - Travel Off Path

LIST: Beaches, parks with restricted access in the Coastal Bend – KIIITV.com

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CORPUS CHRISTI, Texas Kleberg County

Kleberg County will be following Nueces County's ordering restricting vehicular access to the beaches and setting a curfew until August 1. The curfew will be from 8:30 p.m. - 6 a.m.

Pedestrians will still be allowed. The order does not impact Baffin Bay or Loyola Beach.

North and McGee Beach Rules

Padre Island Gulf Beach Rules

RockportOfficials in Rockport have decided to close vehicular traffic into Rockport Beach beginning Sunday, July 19 at 11:59 p.m. until Saturday, Aug 1. at 6 a.m.

Pedestrian access will still be available.

The Aransas County Navigation District said boat ramps -- other than the beach ramp -- will remain open.

Nueces County beaches, parks, local pools and splash pads:

Tougher restrictions are coming back to our coastal beaches from July 15 until August 1. Vehicles will not be allowed on the beaches. However, walking is permitted. There will also be a curfew from 8:30 p.m. to 6:30 a.m. Parks and city pools are also being shut down.

From Port Aransas down to the Padre Island National Seashore, beaches will once again be closed to vehicle traffic.

"We are just trying to reduce as many exposure options as we can," Mayor McComb said.

Mayor McComb acknowledged that the move to reinstate beach restrictions won't be a popular idea for some residents, but it is something that had to be done.

"Going to be extremely important for us to try and get the curve to start going down," City Manager Peter Zanoni said.

Zanoni said the order is mostly aimed at keeping an influx of tourists from descending on our area and adding to the spread of the virus. He said over the Memorial Day weekend 25,000 vehicles went over the JFK Causeway. When beach access was restricted during the Fourth of July weekend, there were only 4,000 vehicles.

"By closing vehicle traffic access, it will restrict the number of persons coming into the city and going onto the beach and that's the goal," Zanoni said.

North Beach and McGee Beach will also see access restrictions. You have to be active on those two beaches.

Meanwhile, the city has also announced a list of eight regional parks that will be closed along with city pools and splash pads.

City Splash Pads Closures

Sunrise Beach RV Park at Lake Corpus Christi Closure

Corpus Christi Marina - Jet Skis Closed

"Staff were telling me today that some of our pools right now have 100 children and that's at 50-percent capacity," Zanoni said.

Health experts said the spread of the virus is happening among families and close contact with people they know.

Leaders said the order could be extended if the numbers continue to climb.

Additional highlights from the press briefing on July 15:

For the latest updates on coronavirus in the Coastal Bend, click here.

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Friends of Sears Island to host Yoga on the Beach with Missy Hatch – Bangor Daily News

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SEARS ISLAND Join Friends of Sears Island for socially-distant yoga on the beach with Missy Hatch from 10-11:15 a.m. Friday, July 24. Using the beach environment, Hatch will engage participants in a relaxing exploration of movement and stretching, taking advantage of all the natural world has to offer for support. This class is for anyone able to walk on the beach. It will be geared for adults but attentive children are also welcome. In the interest of providing a safe experience, pre-registration is required and space is limited. Please register at: https://searsislandyoga.eventbrite.com

Hatch has been teaching yoga since 1989 and enjoys hiking and being outside. No matter the surroundings, there are always stretches that can be done; being unconventional is the fun part. Sears Island is located on Sears Island Road off Route 1 just east of Searsport. Registered participants should park along the causeway at the end of the road and meet at the kiosk near the island gate by 10 a.m. Please wear comfortable clothing and bring a beach towel and water. Masks are welcome, but not required as long as social distancing rules are followed. Please no pets for this event. For more information and updates in the event of inclement weather, visit friendsofsearsisland.org, facebook.com/friendsofsearsisland or call 207-975-3878.

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Friends of Sears Island to host Yoga on the Beach with Missy Hatch - Bangor Daily News

Snowy plover violations lead to temporary closure of Vandenberg AFB’s Minuteman Beach – KSBY San Luis Obispo News

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Minuteman Beach at Vandenberg Air Force Base is temporarily closed due to increased snowy plover violations.

Base officials say the closure, which took effect Monday, will allow them to research and implement more safeguards to protect snowy plover nesting areas.

"Wing leadership knows how important beach access is to the base community," said Col Anthony Mastalir, commander, 30th Space Wing in a statement to KSBY News. "Especially during this time when we are restricted because of the coronavirus pandemic and we must follow the federally mandated guidelines to protect the Snowy Plover, so the hope is that the base community members will follow the guidelines, stay out of the areas that are designated for Plover Nesting and keep the violations down so the beach can reopen in the coming days."

Restrictions are enforced yearly from March 1 through Sept. 30 at Wall, Minuteman and Surf beaches on base property during the federally-listed plover nesting season.

Officials say the current and temporarily closure is designed to prevent a full closure of Minuteman Beach for the remainder of the nesting season.

The beach, which is only accessibly to those on the base, will re-open once additional safeguards have been put into place.

Surf Beach remains open.

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Snowy plover violations lead to temporary closure of Vandenberg AFB's Minuteman Beach - KSBY San Luis Obispo News

In Remission for 10 Years: Long-term Data on CAR-T Therapy – Medscape

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When a patient with cancer hears there isn't much left that doctors can do, it always stays fresh in the mind.

Doug Olson was first diagnosed with chronic lymphocytic leukemia (CLL) over 20 years ago, in 1996. For several years, his doctors used the watch-and-wait approach. But then his cancer progressed and needed treatment. By 2010, it had mutated so much that it no longer responded to standard therapy.

He was rapidly running out of options. Back then, the only treatment left was a bone marrow transplant. Without one, his doctors said, he would have 1 or 2 years left to live.

"I was really trying to avoid a bone marrow transplant. You're playing your last card if that doesn't work. It's a pretty rough procedure," Olson told Medscape Medical News.

Looking back, Olson counts himself as lucky for being in the right place, at the right time, with the right doctor. His oncologist was David Porter, MD, the principal investigator on a trial at the University of Pennsylvania that was investigating a brand new approach to treating cancer: chimeric antigen receptor (CAR) T-cell therapy.

CAR T-cell therapy uses a patient's own T cells engineered to express a receptor that targets proteins on cancer cells. CAR T cells are considered "living drugs" because they expand inside the body and stick around for years maybe for a lifetime to fight the cancer if it tries to come back.

"I was certainly intrigued by the approach. It had worked in mice, and it was the sort of thing that looked like it would work," Olson recalled.

Science is not a foreign language to Olson. He holds a PhD in medicinal chemistry, spent most of his career in the in vitro diagnostics industry, and currently acts as chief executive officer of Buhlmann Diagnostics Corp.

So he read the clinical protocol for the first in-human trial of CAR T cells and agreed to become patient number two.

Olson's T cells were harvested, engineered to attack the CD19 antigen found on malignant and normal B lymphocytes, and then were expanded into millions in the lab. After undergoing preconditioning with chemotherapy to minimize rejection and boost the CAR T cells' expansion inside the body, he received several infusions of the new therapy over the course of 3 days.

Nothing really happened for 2 weeks. Then he developed severe flu-like symptoms so bad that he was hospitalized.

Ironically, getting sick was a sign that the CAR T cells were working. Olson was experiencing one of the main short-term effects of CAR T-cell therapy: cytokine release syndrome. Symptoms include extremely high fevers and dangerous drops in blood pressure that can potentially cause end-organ damage.

In the early trials of these products, some patients experienced such a severe reaction that they needed intensive care, and some died. With increasing clinical experience, doctors have learned to control the reaction with the use of steroids and interleukein-6 inhibitors such as tocilizumab (Actemra).

Fortunately for Olson, the reaction passed, and he was eventually discharged.

Then the "aha moment" happened. Four weeks after receiving the CAR T cells, Olson found out that he was cancer free.

"It still gives me shivers," he said. "Dr Porter said, 'Your bone marrow's completely free. We just can't find a cancer cell anywhere.' "

The remission has lasted, and it is now 10 years later.

Long-term data have been accumulating for these novel therapies since Olson's treatment in 2010. This is particularly important for CAR T-cell therapy, because of its longevity. Because these are living cells and are expected to persist in the body for years, there is great interest in longer-term data, especially the risks for toxicity.

The FDA requires clinical follow-up for at least 15 years for patients treated with CAR T-cell therapy or any other genetically modified cells.

So far, most of the experience with CAR T cells comes from anti-CD19-directed therapy, which has shown "remarkable" remission rates in the 50% to 85% range, said Nirali Shah, MD, head of the hematologic malignancies section of the Pediatric Oncology Branch at the National Cancer Institute (NCI).

The most recent results presented at this year's annual meeting of the American Society of Clinical Oncology support earlier efficacy data, she noted. In the longest follow-up to date, researchers reported remissions lasting over 9 years in patients with relapsed/refractory B-cell lymphoma or CLL treated with Kite's axicaptagene cilleucel (Yescarta), one of two anti-CD19-directed CAR T-cell therapies approved by the FDA in 2017 (the other is Novartis' tisagenlecleucel [Kymriah]).

This study included 43 patients and showed an overall remission rate of 76%. Complete remission was achieved in 54% of patients, and 22% had partial remission.

The other focus is long-term safety. Although some of the long-term adverse effects are known and are manageable, others fall into the theoretical realm. In early May 2020, the NCI held a multidisciplinary virtual conference on CAR T-cell therapy "to encourage collaborative research about the subacute and potentially long-term toxicity profile of these treatments."

"We know just a little at this point about late- and long-term effects of CAR-T therapy, because we are relatively early in the era of CAR T cells," said Merav Bar, MD, from the Fred Hutchinson Cancer Research Center in Seattle, Washington.

What is known is that B-cell aplasia represents the most common long-term adverse effect of CAR T-cell therapy. B-cell aplasia results when anti-CD19 CAR-T therapy wipes out healthy B cells as well as the malignant ones responsible for leukemia/lymphoma.

As major players in the immune system, B cells are a key defense against viruses. So B-cell aplasia represents a very specific type of immunosuppression. It is generally less severe than immunosuppression that occurs after organ transplant, which hits the immune system pretty much across the board and carries a much higher risk for infection.

The main concern is what happens when someone with B-cell aplasia encounters a new pathogen, such as SARS-CoV-2.

After infection, B cells generate memory cells, which are not killed off by anti-CD19 therapy and that stick around for life. So a patient such as Olson would still make antibodies that fight infections they experienced before receiving CAR-T therapy, such as childhood chickenpox. But now they are unable to make new memory cells, so these patients receive monthly immunoglobulin infusions to protect against pathogens they have not previously encountered.

Olson takes this in stride and says he isn't overly worried about COVID-19. He follows the recommended precautions for a man his age. He wears a mask, washes his hands frequently, and tries to maintain social distancing. But he doesn't stay locked up in his New Hampshire home.

"I took the attitude when I was diagnosed with cancer that I'm going to live my life," he said. "Quality of life to me is more important than quantity."

Another problem is the possibility of neuropsychiatric toxicity. Past studies have reported a wide range of such toxicities associated with CAR T-cell therapy, including seizures and hallucinations. Most have occurred early in the course of treatment and appear to be short-lived and reversible. However, there remain questions about long-term neuropsychiatric problems.

In a long-term study of 40 patients with relapsed/refractory CLL, non-Hodgkin lymphoma, and ALL, nearly half of patients (47.5%, 19/40) self-reported at least one clinically meaningful negative neuropsychiatric outcome (anxiety, depression, or cognitive difficulty) 1 to 5 years after anti-CD19 CAR T-cell therapy. In addition, 37.5% (15/40) self-reported cognitive difficulties.

"Patients with more severe neurotoxicity showed a trend for more cognitive difficulties afterwards," said Bar, senior author of the study.

However, teasing out the role that CAR T-cell therapy plays in these problems poses a challenge. All of these patients had been heavily pretreated with previous cancer therapy, which has also been associated with neuropsychiatric problems.

"So far, we don't know what caused it," Bar said. "Nevertheless, people need to pay attention to neuropsychiatric symptoms in CAR T-cell therapy. It is important to continue to monitor these patients for these issues."

Another potential problem is graft-vs-host disease (GVHD). This is not uncommon after hematopoietic stem cell transplants. It develops when the donor T cells view antigens on healthy recipient cells as foreign and attack them.

For patients who are treated with CAR T cells, GVHD is mostly a concern among individuals who have previously had a transplant and who are already at increased risk for it.

In a study of late effects among 86 adults treated with anti-CD19 CAR T cells for relapsed/refractory non-Hodgkin lymphoma, Bar and colleagues found that GVHD occurred only among patients who had received a previous donor stem cell transplant. Of these, 20% (3/15) developed GVHD about 28 months after CAR-T therapy.

"The data for CAR T cells causing GVHD really hasn't shown that it's a huge problem, although we have seen it and are continuing to monitor for it," the NCI's Shah commented to Medscape Medical News.

A range of other long-term adverse effects have been reported with CAR-T therapy, including prolonged cytopenias (reduced mature blood cells), myelodysplasia (bone marrow failure), and second malignancies.

In the study with the longest follow-up to date, 16% (7/43) of patients developed second malignancies, which is comparable to data from Bar's study in Seattle (15%, 13/86). The researchers in this study consider this rate to be no higher than expected: these patients had already received extensive chemotherapy, which increases the risk for other cancers, they point out.

However, this brings up theoretical concerns about the long-term effects of gene modification. CAR T cells are engineered using retroviruses (mainly lentiviruses), which randomly insert the CAR genes into the host genome. Doing so may cause mutations that could promote cancer. These lentiviruses also carry the theoretical risk of becoming capable of viral replication once inside the body.

To address these concerns, viruses used to engineer CAR T cells go through comprehensive safety testing. After therapy, patients are checked every few months during the first year and annually after that.

So far, there have been no reports of cancers associated with CAR T-cell therapy.

"Any type of cancer is a very theoretical risk," Bar told Medscape Medical News. "Most likely the malignancies in our study were related to prior treatment that the patients received. None of them had any evidence of replication-competent lentivirus, or any other evidence that the malignancies were related to the CAR T cells."

Another theoretical concern is the possibility of new-onset autoimmune disease, although, once again, no cases have been reported so far.

"We think of it as a theoretic possibility. Whenever you jack up the immune system, autoimmune disease is a potential risk," said Carl June, MD, director of the Center for Cellular Immunotherapies at the University of Pennsylvania.

June was the coprincipal investigator of the trial in which Olson participated. He is also the inventor on patents for CAR T cells licensed by the University of Pennsylvania to Novartis and Tmunity and is a scientific founder with equity in Tmunity.

Still, autoimmunity could occur, and scientists are looking out for it.

"We are continuing to be vigilant in our monitoring for autoimmune disease," Shah added. "We've been doing CAR T-cell therapy since 2012, and I think we have yet to see true autoimmunity beyond GVHD."

In the 10 years since Olson received CAR T-cell therapy, an entire industry has sprung up. Over 100 companies worldwide are now developing CAR T-cell therapies targeting various antigens. These therapies are directed at about 60 different tumor types, including solid tumors. Nearly 200 clinical trials are underway, though most are still in early stages: as of September 2019, only 5% had reached phase 3.

Clinical data show promising results for CAR T-cell therapy directed against CD22 (overexpressed on ALL cells), and BCMA (found on almost all multiple myeloma cells). Yet questions remain as to whether CAR T cells will be as effective if they target antigens other than CD19 or cells other than B lymphocytes. One of the biggest research questions is whether they will be effective against solid tumors.

One research avenue being watched with great interest is the development of universal CAR T cells. So far, such products are at very early stages of development (phase 1 trials), but they are attractive because of the potential advantages they offer over bespoke CAR T cells. Automating the process holds the promise of immediate availability, standardizing production, expanding access, and lowering costs. And because the T cells for this universal product come from healthy donors, they may function better than T cells that have been battered and bruised by past cancer treatments, or even the cancer itself.

However, precisely because they are developed from healthy donor T cells, universal CAR T cells may pose increased risk for GVHD. Scientists are trying to get around this problem by engineering universal CAR T cells that lack the T-cell receptor involved in GVHD.

There are also other concerns. Nature has a penchant for mutation. Engineering CAR T cells without T-cell receptors means the body may no longer detect or reject a universal CAR T cell if it goes rogue. Also, gene insertion in universal CAR-T therapy is targeted rather than random (as in bespoke CAR T cells), which could create off-target effects. Both issues create a theoretical risk of such products inducing an untreatable CAR T-cell therapyassociated cancer.

"The theoretic risk with universal cells is that their safety profile may not be as good for long term," June commented.

From that first trial in which June and Porter used CAR T cells, two of three patients they treated are still alive 10 years later.

Olson is one of these two, and he still undergoes monitoring every 3 months to check for relapse. So far, none of his tests have shown signs of his cancer returning.

After going into remission, Doug spent the next 6 to 9 months regaining his health and strength.

"I figured if I had this amazing treatment that saved my life, I had an obligation to stay alive," he said. "I'd better not die of something like a heart attack!"

He took up long distance running and has completed six half marathons. He became involved in the Leukemia and Lymphoma Society, participating in fund-raising and helping newly diagnosed patients. Over the years, he has also given talks for researchers, people with cancer, and healthcare providers.

Doug is now 73. Today, he marvels at how rapidly the CAR-T field has progressed.

"Twenty years ago, if you had cancer, your prospects weren't nearly as good as these days. In 2010, people still didn't believe in CAR T-cell therapy," he said. "My goal always in telling my story is a message of hope."

For more from Medscape Oncology, join us on Twitter and Facebook.

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In Remission for 10 Years: Long-term Data on CAR-T Therapy - Medscape

Global Stem Cell Therapy Market 2020 Industry (Covid-19 Impact) Size, Share, Trend and Forecast 2025: Anterogen Co. Ltd., MEDIPOST Co. Ltd., Osiris…

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Stem Cell Therapy Market analysis is provided for the international markets including development trends, competitive landscape analysis, geography, end-users, applications, market share, COVID-19 analysis, and forecast 2020-2025. The predictions estimated in the market report have been resulted in using proven research techniques, methodologies, and assumptions. This Stem Cell Therapy market report states the market overview, historical data along with size, growth, share, demand, and revenue of the global industry.

Global Stem Cell Therapy Market study with 100+ market data Tables, Pie Chat, Graphs & Figures is now released by Adroit Market Research. The report presents a complete assessment of the Market covering future trends, current growth factors, attentive opinions, facts and industry-validated market data forecast until 2025.

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The research report on Stem Cell Therapy Market provides a comprehensive analysis of the market status and development trend, including types, applications, growth, opportunities, rising technology, competitive landscape and product offerings of key players. Stem Cell Therapy Market report covers the present and past market scenarios, market development patterns, and is likely to proceed with a continuing development over the forecast period. Stem Cell Therapy Market report provides in-depth statistics and analysis available on the market status of the Stem Cell Therapy key players and is a valuable method of obtaining guidance and direction for companies and business enterprise insider considering the Stem Cell Therapy market. It contains the analysis of drivers, challenges, and restraints impacting the industry.

Top Leading Key Players are:Anterogen Co., Ltd. (South Korea), MEDIPOST Co., Ltd. (South Korea), Osiris Therapeutics, Inc. (U.S.) and Pharmicell Co., Ltd.

Read complete report with TOC at: https://www.adroitmarketresearch.com/industry-reports/stem-cell-therapy-market

The segmentation chapter allows readers to understand aspects of the Global Stem Cell Therapy Market such as types, available technologies, and applications. These chapters are written in a way that describes years of development and the process that will take place in the next few years. The research report also provides insightful information on new trends that are likely to define the progress of these segments over the next few years.

Global Stem Cell Therapy market is segmented based by type, application and region.

Based on Type, the market has been segmented into:Based on cell source, the market has been segmented into,

Adipose Tissue-Derived Mesenchymal SCsBone Marrow-Derived Mesenchymal SCsEmbryonic SCsOther Sources

Based on Application, the market has been segmented into:Based on therapeutic application, the market has been segmented into,

Musculoskeletal DisordersWounds & InjuriesCardiovascular DiseasesGastrointestinal DiseasesImmune System DiseasesOther Applications

Regional and Country- level Analysis Stem Cell Therapy market of different geographical areas are studied deeply and an economical scenario has been offered to support new entrants, leading market players, and investors to regulate emerging economies. The top producers and consumers focus on production, product capacity, value, consumption, growth opportunity, and market share in these key regions, covering

Stem Cell Therapy Market Segment by Regions, regional analysis covers North America Europe Asia-Pacific South America Middle East and Africa

Stakeholders Benefit:1. Analysis of emerging trends, and key market dynamics.2. Comprehensive analysis of products and segmentation.3. Competitive analysis and key strategies followed by the key players in the market.4. PEST and Poster analysis, and many more.5. COVID-19 Impact detailed analysis.

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Global Stem Cell Therapy Market 2020 Industry (Covid-19 Impact) Size, Share, Trend and Forecast 2025: Anterogen Co. Ltd., MEDIPOST Co. Ltd., Osiris...

COVID-19 Fibroblast Based Cell Therapy Candidate Shown to Reduce Lung Scarring in Aggressive Animal Model – Tyler Morning Telegraph

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HOUSTON, July 21, 2020 /PRNewswire/ --FibroGenesis announced today new data supporting use of its PneumoBlast product in the battle against COVID-19.Using the widely accepted bleomycin model of lung scarring (fibrosis), Company scientists have demonstrated the administration and use of PneumoBlast induced a 51% reduction of lung fibrosis,which was statistically significant (p < .005). Importantly, when PneumoBlast was compared head to head with bone marrow derived mesenchymal stem cells (BMSCs) for COVID-19, PneumoBlast was 221% more effective. In producing the potent anti-inflammatory protein interleukin 1 receptor antagonist, which is believed to be the mechanism of scar tissue prevention by BMSC therapies currently in development, PneumoBlast was 192% more effective than BMSCs which was again, statistically significant(p < .005).

During an interview with Healthline.com, Dr. Lori Shah, transplant pulmonologist at New York-Presbyterian/Columbia University Irving Medical Center, stated "Holes in the lungs likely refers to an entity that has been dubbed 'post-COVID fibrosis,' otherwise known as post-ARDS [acute respiratory distress syndrome] fibrosis, which is irreversible and can result in severe functional limitations from patients, such as cough, shortness of breath, and need for oxygen." It has been reported that pulmonary fibrosis due to COVID-19 is occurring in increasing numbers of patients in their 20s and 30s.

"COVID-19 represents a new clinical entity which not only causes death through lung inflammation, but in some patients causes permanent lung injury through stimulation of scarring," said Tom Ichim, Ph.D., Chief Scientific Officer of FibroGenesis. "The prospects that our cell therapy approach not only possesses therapeutic effects on animal models of the acute stage of COVID-19, but also benefits the long-term pathology, has our research team extremely excited."

"As the scientific and medical community is discovering more about the biological and medical consequences of the COVID-19 infection, FibroGenesis is eager to contribute to the therapeutic cure options currently being created to fight this global war against an invisible enemy," commented Pete O'Heeron, President/CEO of FibroGenesis. "While we are excited about potential vaccines in the pipeline, the fact remains that there are 3.8 million confirmed cases of COVID-19 in the U.S. and we do not know what the long-term outcomes for these patients will be. To our knowledge, we are the only cell therapy company which is creating a therapy to resolve the initial pathology of infection and also proactively tackling its long-term consequences."

About FibroGenesis

Based in Houston, Texas, FibroGenesis, is a regenerative medicine company developing an innovative solution for chronic disease treatment using human dermal fibroblasts. Currently, FibroGenesis holds 235+ U.S. and international issued patents/patents pending across a variety of clinical pathways, including Disc Degeneration, Multiple Sclerosis, Parkinson's, Chronic Traumatic Encephalopathy, Cancer, Diabetes, Liver Failure, Colitis and Heart Failure. Funded entirely by angel investors, FibroGenesis represents the next generation of medical advancement in cell therapy.

Visit http://www.Fibro-Genesis.com.

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COVID-19 Fibroblast Based Cell Therapy Candidate Shown to Reduce Lung Scarring in Aggressive Animal Model - Tyler Morning Telegraph

Autologous Stem Cell and Non-Stem Cell Based Therapies Market 2027 : Which technology is expected to trend higher? – 3rd Watch News

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Autologous stem-cell transplantation is the autologous transplantation of stem cells. User preserves his own cells which can be used later. This is considered to be one of the effective and safer way to treat the diseases such as cancer. It is safer technology when compared with allogeneic and xeno transplants. IT reduces the risk of disease transmission, bio-incompatibility, and immunological reactions.

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The Autologous Stem Cell and Non-Stem Cell Based Therapies market is anticipated to grow in the forecast period owing to driving factors such as rising prevalence of cancer and diabetes, growing geriatric population, favorable reimbursement scenarios across several countries.

Top Dominating Key Players:

The Global Autologous Stem Cell and Non-Stem Cell Based Therapies market is segmented on the basis of application and end user. Based on application the market is segmented into Neurodegenerative, Cardiovascular, Cancer & Autoimmune, Skin and Infectious Diseases. Based on end user, the market is segmented into hospital and research institute.

The report provides a detailed overview of the industry including both qualitative and quantitative information. It provides overview and forecast of the global Autologous Stem Cell and Non-Stem Cell Based Therapies market based on various segments. It also provides market size and forecast estimates from year 2017 to 2027 with respect to five major regions, namely; North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South & Central America. The Autologous Stem Cell and Non-Stem Cell Based Therapies market by each region is later sub-segmented by respective countries and segments. The report covers analysis and forecast of 18 countries globally along with current trend and opportunities prevailing in the region.

The report analyzes factors affecting Autologous Stem Cell and Non-Stem Cell Based Therapies market from both demand and supply side and further evaluates market dynamics effecting the market during the forecast period i.e., drivers, restraints, opportunities, and future trend. The report also provides exhaustive PEST analysis for all five regions namely; North America, Europe, APAC, MEA and South & Central America after evaluating political, economic, social and technological factors effecting the Autologous Stem Cell and Non-Stem Cell Based Therapies market in these regions.

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Autologous Stem Cell and Non-Stem Cell Based Therapies Market 2027 : Which technology is expected to trend higher? - 3rd Watch News

Growing Infrastructure Development Projects in Asia-Pacific to Fuel Growth of the Animal Stem Cell Therapy Market 2017 2025 – Bulletin Line

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According to the latest report published by PMR, the Animal Stem Cell Therapy market is anticipated to grow at a steady pace over the forecast period (2019-2029). The report sheds light on the various trends and restraining factors that are expected to shape the growth of the Animal Stem Cell Therapy in the upcoming years. The report ponders over the various parameters that are expected to impact revenue generation, sales, and demand for the Animal Stem Cell Therapy in the various regional markets.

According to the study, the Animal Stem Cell Therapy market is likely to attain a market value of ~US$ XX by 2019 and grow at a CAGR of ~XX% during the assessment period. The market study introspects the competition landscape of the Animal Stem Cell Therapy market and highlights the key developments and technological innovations witnessed in the current Animal Stem Cell Therapy market landscape.

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Key findings of the Animal Stem Cell Therapy market report:

Animal Stem Cell Therapy Market Segmentation

The report dissects the Animal Stem Cell Therapy market into different segments to provide a fair understanding of the different aspects of the Animal Stem Cell Therapy market.

The regional analysis of the Animal Stem Cell Therapy market sheds light on the growth prospects of the Animal Stem Cell Therapy market in different regions. The current market trends, the impact of regulatory policies, market share, size, and value of each regional market are presented in the report supported by easy-to-understand graphs and tables.

Key Participants

The key participants in the animal stem cell therapy market are Magellan Stem Cells, ANIMAL CELL THERAPIES, Abbott Animal Hospital, VETSTEM BIOPHARMA, Veterinary Hospital and Clinic Frisco, CO, etc. The companies are entering into the collaboration and partnership to keep up the pace of the innovations.

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Growing Infrastructure Development Projects in Asia-Pacific to Fuel Growth of the Animal Stem Cell Therapy Market 2017 2025 - Bulletin Line

Restorative therapies for erectile dysfunction: Where are we at in 2020? – Urology Times

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Restorative therapies are an exciting area of potential treatments for patients with erectile dysfunction (ED); however, there is a paucity of clinical data regarding their efficacy and safety, according to Trinity Bivalacqua, MD, PhD.1

The goal of restorative therapies in ED is to reestablish whole-organ function and reverse penile dysfunction using regenerative medicine technology, Bivalacqua explained in a presentation during the 2020 AUA Virtual Experience. The restorative therapies for ED include platelet rich plasma (PRP), stromal vascular fraction (SVF), amniotic fluid (AF), and stem cells (mesenchymal cells, adipose derived stem cells, amniotic stem cells, and cord blood stem cells).

Restorative therapies are particularly relevant for patients who have had radical prostatectomies and have post-prostectomy ED, as well as for patients with severe ED as it relates to peripheral vascular disease and diabetes, said Bivalacqua, director of Urologic Oncology at Johns Hopkins Univsersity.

Although the potential of restorative therapy to treat ED itself, and not just its symptoms, has created a lot of buzz in the urology community, Bivalacqua said the lack of data in the literature backing the efficacy and safety of the technology means it should currently be reserved for clinical trials. Accordingly, this is the current position of the Sexual Medicine Society of North America (SMSNA), which sponsored Bivalacquas discussion:

Given the lack of regulatory agency approval for any restorative (regenerative) therapies for the treatment of ED and until such time as approval is granted, SMSNA believes that the use of shock waves or stem cells or platelet rich plasma is experimental and should be conducted under research protocols (clinical trials) in compliance with Institutional Review Board approval.

In his discussion during the AUA online platform, Bivalacqua discussed the limited available evidence in the literature for each ED-focused restorative therapy and the next steps for this technology.

PRP is the most common restorative therapy used for ED. This treatment can be applied through intracavernous injection. Although he did not make a recommendation for its use outside of clinical trials, Bivalacqua said PRP Falls under the HCT/P 361 exemption proposed by the FDA. This means in clinical practice you can usePRPwithout gaining FDA approval. As long as the tissue/biospecimen is not manipulated once its removed from the patient, it is then exempt from FDA approval and clinical trials.

With PRP, a clinician can use a normal centrifuge to isolate the PRP, which can then be injected. It does not have a specific CPT billing code, but can be categorized under a nonspecific code for blood transfusion and reinfection. For the most part, it is not covered by insurance or Medicare, with the post common payment form being cash, said Bivalacqua. Regarding clinical evidence, there have been no randomized clinical trials of PRP.

Bivalacqua said there is 1 peer-reviewed trial2 of PRP in the literature, but it only had safety results. The study assessed PRP in 17 patients with various urological diseases, including 4 patients with ED. The results showed that PRP injections were safe overall, with some mild bruising, but no serious adverse events.

Autologous SVF involves the removal of adipose tissues, often through liposuction. The removed tissues are then separated into individual components, with the key components, such as adipose-derived stemcells(ADSCs)and endothelial precursorcells(EPCs), being reinjected into the patient. ADSCs and EPCs release beneficial cytokines and growth hormones, which promote tissue survival, angiogenesis, and further stem cell recruitment, said Bivalacqua.

Since SVF involves the patient specimens being manipulated, unlike with PRP, this procedure does not fall under the FDA HCT/P 361 exemption and no SVF devices are currently FDA approved. There is also no clinical trial data in the literature supporting the efficacy of SVF.

Some trials have been published showing promise for low-intensity shockwave therapy as a treatment for patients with ED. One study3 looked at the long-term efficacy of low-intensity shockwave therapy using an electrohydraulic device in 156 patients who initially had a successful outcome according to the minimal clinically important difference on the International Index of Erectile Function-Erectile Function (IIEF-EF). Patients were assessed per the IIEF-EF at 6, 12, 18, and 24 months.

Although the treatment was successful in 63.5% (n = 99) of patients at 1 month after treatment, efficacy gradually decreased over time. Among the 99 patients who initially responded, only 53 (53.5%) were still experiencing a beneficial treatment effect at 2 years follow-up.

They found that there was very little durability of the shock-wave therapy in patients with severe ED. Whatever effect was seen was then mitigated at 24 months, said Bivalacqua. Those patients with non-severe EDthose who would typically respond to PDE-5 inhibitorshad a more efficacious response.

Another study4 of low-intensity shockwave therapy used an electromagnetic device to treat patients with ED. There were 87 evaluable patients who were randomized to receive 1 of 2 shockwave regimens: Group A (n= 45) received 3600 shocks (720/day) over 5 days and Group B (n = 42) received 3600 shocks over 2 weeks (600 over 3 days each week). The was a statistically significant improvement in IIEF-EF score for both groups, with a mean increase of 2.7 in both group A and group B (P <.05). There was also a statistically significant improvement in Erectile Hardness Scale score in both arms at 0.6 points in group A and 0.5 points in group B.

Although the improvements were statistically significant, the benefits were minor, leaving Bivalacqua to ask, The question is, Is this clinically significant? My perspective on this is that this did not include a sham group and the improvement was in patients who were typically PDE-5inhibitorresponders. But I do think we have to acknowledge that using the electromagnetic probe, which causes a lower peak energy, may be safer for patients.

While it is an exciting field, Bivalacqua noted that there is an ugly side to restorative therapies for ED

The global use of PRP, especially in North America, is very high, despite the lack of any clinical evidence that it is effective or safe, said Bivalacqua, adding, Some practitioners are cashing in on the hype of shockwave therapy even though the treatments are not FDA approved.

To combat these issues, Bivalacqua said several questions need to be answered in the literature. The next steps with restorative therapies are determining optimal dosing regimens; assessing the total power and number of shocks with shockwave devices; determining the optimal device choiceelectromagnetic versus electrohydraulic; and evaluating the duration of studies and role of maintenance therapy. But more importantly, we need to have a sham in randomized controlled trials.

Bivalacqua also provided several suggestions on how the efficacy of the available restorative therapies could be improved.

The future is combination therapy, where we include low-intensity shockwave therapy with the injection of either SVF or stem cells. And we have to include a maintenance phase. Other protein- and gene-based therapies, such as SDF-1, which hone stem cells, are obviously an important next step. And neurotrophic factors placed at the time of radical prostatectomy are the only way that we are going to be able to regenerate nerves post prostatectomy.

References

1. Bivalacqua T. State-of-the-Art Lecture: Update on Clinical Trials on Restorative Therapies for Erectile Dysfunction. Presented during 2020 AUA Virtual Experience. June 27-28, 2020.

2. Matz EL, Pearlman AM, Terlecki RP, et al. Safety and feasibility of platelet rich fibrin matrix injections for treatment of common urologic conditions. Investig Clin Urol. 2018;59(1):61-65. doi: 10.4111/icu.2018.59.1.61

3. Kitrey ND, Vardi Y, Appel B, et al. Low intensity shock wave treatment for erectile dysfunction-how long does the effect last? J Urol 2018;200(1):167-170.doi: 10.1016/j.juro.2018.02.070

4. Patel P, Katz J, Lokeshwar SD, et al. Phase II randomized, clinical trial evaluating 2 schedules of low-intensity shockwave therapy for the treatment of erectile dysfunction. Sex Med. 2020 Jun; 8(2): 214222. doi: 10.1016/j.esxm.2020.01.010

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Restorative therapies for erectile dysfunction: Where are we at in 2020? - Urology Times

The Bahamas Bans American Travelers Due To Covid-19 Concerns – Forbes

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Atlantis Resort Paradise Island in Nassau, Bahamas.

As of Wednesday, July 22, you can add The Bahamas to the growing list of countries not allowing Americans to visit this summer. Prime Minister Hubert Minnis announced the move during a National Address on Sunday, July 19, saying it was in response to an increase in Covid-19 cases49 new occurrences since the countrys borders officially opened to travelers on July 1. Flights from Canada, the United Kingdom and the European Union, however, are still permitted at this time.

While there are countries that continue to make progress, such progress can be reversed because of what is happening in neighboring and other countries. Progress can also be reversed because of how citizens and residents within countries are following or ignoring health guidelines, said Minnis. Regrettably, the situation here at home has already deteriorated since we began the reopening of our domestic economy. It has deteriorated at an exponential rate since we reopened our international borders.

As a result, starting Wednesday, July 22, regular international flights and commercial sea vessels from the United States will not be allowed to enter The Bahamas, while flights from Canada, the United Kingdom and the European Union will be allowed to continue. Interestingly, a tweet by the Prime Ministers account and the Bahamian Tourism website states that private international flights and charters and private pleasure crafts and yachts are still allowed to enter The Bahamas from all countries.

Travelersbasically, anyone who isnt carrying a U.S. passportare able to enter the country as long as they acquire a health visa electronically and show they have a negative RT-PCR Covid-19 test result from a test taken no more than 10 days before their trip. Those without the proper documentation and test results are required to quarantine in a government-identified facility for 14 days at their own expense.

While in The Bahamas, social distancingstaying at least six feet from anyone outside your groupand mask-wearing are mandatory anytime youre in public. This includes anytime youre waiting in line for attractions, restaurants, taxis, or hotels, when youre coming to or from the beach, or before and after exercise. Anyone not following the rules is subject to a $200 fine, a month in prison, or even both, so dont chance it. Also be aware that gatherings on the beach are limited to five people or fewer and due to a countrywide curfew, you must be back at your hotel, Airbnb or other accommodation between 10 p.m. and 5 a.m.

The Prime Minister also announced that as of July 20, beaches and parks in New Providence, Paradise Island, Rose Island, Athol Island, and other surrounding cays would be closed indefinitely, as will the restaurants at Arawak Cay and Potters Cay.

On Grand Bahama, where 31 of the latest 49 cases have occurred, all beaches and parks are closed and a curfew is in place from 7 p.m. to 5 a.m. Ferry service between East End in Grand Bahama and Crown Haven in Abaco has been suspended, as well as all indoor dining on the island, while outdoor dining, delivery and pick-up are still permitted. All bars and Fish Frys are also closed until further notice.

Like other nations that responded well at the outset of the pandemic, The Bahamas is working through the same balancing act, Minnis said during the National Address. We are trying to get Bahamians back to work and to promote economic activity, while also limiting the spread of the virus. We are trying to open parts of our economy and our society while promoting and requiring health measures to protect lives.

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The Bahamas Bans American Travelers Due To Covid-19 Concerns - Forbes