Lenalidomide prolongs disease control for multiple myeloma patients after stem cell transplant

Public release date: 15-May-2012 [ | E-mail | Share ]

Contact: Elisa Williams willieli@ohsu.edu 503-494-4530 Oregon Health & Science University

PORTLAND, Ore. Multiple myeloma patients are better equipped to halt progression of this blood cancer if treated with lenalidomide, or Revlimid, following a stem cell transplant, according to a study co-authored by a physician with the Oregon Health & Science University Knight Cancer Institute.

The study, published in the New England Journal of Medicine, found a 63 percent reduction in the risk of progressive myeloma or death for the stem cell transplant patients that were treated with lenalidomide maintenance therapy.

"These results add to the evidence that the combination of standard therapies such as stem cell transplantation with the emerging biologic therapies, like lenalidomide, have extended the lives of multiple myeloma patients," said Richard Maziarz, M.D., of the OHSU Knight Cancer Institute who was one of the study's co-authors. Maziarz serves as medical director of the Adult Stem Cell Transplantation Program & Center for Hematologic Malignancies at the OHSU Knight Cancer Institute. "We know that for at least three years following a transplant that maintenance therapy with this drug vastly improves the chances that the cancer won't come back and worsen."

These data were supported by similar Phase III studies reported from France and Italy in the same issue of the New England Jounal of Medicine demonstrating that maintenance therapy after stem cell transplantation was associated with improved disease control.

Multiple myeloma is a cancer that affects plasma cells, a type of white blood cell normally responsible for producing antibodies. In patients impacted by multiple myeloma, collections of abnormal plasma cells accumulate in the bone marrow, interfering with the production of normal blood cells. The study focused on patients who received an autologous hematopoietic cell transplant (AHCT). AHCT procedures use patients' own blood stem cells.

While lenalidomide increased a patient's ability to stave off progression of the disease, questions remain regarding future approaches recognizing that quality of life measurements were not incorporated within these studies, that long-term safety issues remain unclear as there was a small but discernable risk of second cancers observed in the treated patients. In addition to the need for that cost-benefit analysis, a comparison remains to be performed with other emerging myeloma maintenance therapies.

This Phase III study of lenalidomide was conducted at 47 medical centers and involved 568 patients. It was sponsored by the National Cancer Institute (NCI). Revlimid's manufacturer, Celgene Corp., provided the NCI with lenalidomide for this research.

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Lenalidomide prolongs disease control for multiple myeloma patients after stem cell transplant

Stem cell therapy to treat a chimp's torn ACL may prove beneficial for humans

Veterinarians hope a new medical procedure can treat a 25-year-old chimpanzee with a torn ACL, or anterior cruciate ligament, at the "Save the Chimps" in Florida.

The procedure involves injecting the chimp with her own stem cells.

"With chimps we don't want to do a lot of surgical work, put hardware in their knee, they tend to pull out that sort of thing," said Veterinarian Linda Gregard, M.D.

Dr. Darrell Nazareth with the Florida Veterinary League has been using stem cells to treat dogs with arthritis for the past two years, but this is his first chimp.

"We're not using embryonic stem cells, we're not taking embryos and taking their stem cells from there. We're just using the patient's own tissue," said Dr. Nazareth.

The technology harnesses the bodies own ability to heal itself and doctors hope it could find wider use in humans.

After injecting two billion stem cells into Angie's knee, doctors will find out in the next two to three weeks if the stem cell therapy treatment was successful.

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Stem cell therapy to treat a chimp's torn ACL may prove beneficial for humans

Stem cell co Gamida Cell raises $10m

Stem cell therapies developer Gamida Cell Ltd. has raised $10 million in its fifth financing round from all its investors. The company will use the proceeds to support the global commercialization of its lead cell therapy product, StemEx, as an alternative therapeutic treatment for patients with blood cancers, such as leukemia and lymphoma, who can be cured by bone marrow transplantation but do not have a matched bone marrow donor.

Gamida Cell is developing StemEx with Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA), and it is seeking a strategic partner for the product's global commercialization.

The company will also use the proceeds for the further development of other products, primarily a clinical trial of its NiCord treatment for sickle cell anemia and thalassemia.

Gamida Cell chairman Reuven Krupik said, The investors were unanimous in their decision to reinvest, understanding the importance of bringing StemEx to market as well as maintaining the companys leadership role in the stem cell industry. Gamida Cell is a game changer."

Gamida Cell completed enrollment for a pivotal Phase III clinical trial of StemEx in February, and expects results in the fourth quarter. The company plans to launch the product in 2013, and it could be the first allogeneic stem cell product in the market.

The company's current investors include Elbit Imaging Ltd. (Nasdaq: EMITF; TASE: EMIT), Clal Biotechnology Industries Ltd. (TASE: CBI), Israel Healthcare Venture, Teva, Amgen, Denali Ventures and Auriga Ventures.

Published by Globes [online], Israel business news - http://www.globes-online.com - on May 15, 2012

Copyright of Globes Publisher Itonut (1983) Ltd. 2012

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Stem cell co Gamida Cell raises $10m

Vet undertakes stem cell surgery

Animal stem cell regenerative therapy is the newest service at the Animal Hospital of Tiffin.

"We are the official first site for the therapy in Ohio," said veterinarian Bob McClung.

The technology uses an adult animal's stem cells to heal itself.

Veterinarian Mike Brothers performed the surgery Monday on his dog, Tucker, a 2-year-old labrador retriever. It was the second surgery performed at the clinic.

Brothers said his dog's joint problems are hereditary and he's had problems since he was a puppy.

"What we've been able to do is slow down the arthritis," Brothers said. The cause of the degeneration will continue, but the fatty tissue removed from the dog can be used for future treatments.

From a piece of fatty tissue of the size removed from Tucker, McClung estimated $3.2 billion stem cells were harvested.

Each injection uses about 90 million cells, so there will be enough of the material for future treatments.

"We have basically 2 billion cells to bank," he said. "We use cryo-preservation."

In the freezing process, the cells are gradually cooled to prevent damage and stored in liquid nitrogen at temperatures of minus 80 to minus 90 degrees Fahrenheit.

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Vet undertakes stem cell surgery

Stem cell banking firms to deploy marketing initiatives to boost sales

Kolkata, May 15:

Stem cell banking companies are looking at aggressive marketing initiatives to move into the mass market segment. Direct marketing to customers and reduction in price tag for storing umbilical cord blood are on the cards.

The umbilical cord blood and cord tissue are one of the richest sources of stem cells and have potential to treat over 75 serious ailments.

The average cost for storing these for a period of 21 years ranges between Rs 75,000 and Rs 90,000 in India.

According to Chennai-based Life Cell, high price points and lack of proper marketing have limited the penetration of cord blood banking in India. Affordability is the key factor in India.

Only when the prices come down will we see more customers opting for the service. We are working on it (bringing down prices), Mr Mayur Abhaya Srisrimal, Executive Director Life Cell, told Business Line.

Stem cell bankers have already rolled out easy finance options such as EMIs to make the services attractive. CordLife, for instance, offers EMI facility for 12-24 months.

This has helped boost our sales. We have been acquiring 350-400 clients each month, said Managing Director, Mr Meghnath Roy Chowdhury.

Finance, however, is not the only stumbling block. Cord blood bankers have, so far, been depending largely on hospital network for signing up clients. Bangalore-based Ms Deepa Shankar, who is expecting and is due for delivery in June, recently opted for Life Cell services through the hospital.

It's not a sustainable approach. We need to get into direct marketing for pushing up volumes growth, Mr Srisrimal points out. To strike a cord with the would-be mothers, the company has roped in Lisa Ray as brand ambassador. Ms Ray was cured of multiple myeloma courtesy stem cell therapy.

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Stem cell banking firms to deploy marketing initiatives to boost sales

International Stem Cell Corporation Scientists to Present Pre-Clinical Research Results at American Society of Gene …

CARLSBAD, Calif.--(BUSINESS WIRE)--

International Stem Cell Corporation (OTCBB: ISCO.OB - News) (www.internationalstemcell.com) today announced that several of its leading scientists will present experimental results from three of ISCOs pre-clinical therapeutic programs.

Firstly, the application of A9 dopaminergic neurons derived from human parthenogenetic stem cells (hpSC) for the treatment of Parkinsons disease. Demonstrating functional dopaminergic neurons in vivo represents an important milestone towards the goal of creating well characterized populations of cells that could be used to develop a treatment for Parkinsons.

Secondly, the differentiation of hpSC and embryonic stem cells into cornea-like constructs for use in transplantation therapy and the in vitro study of ocular drug absorption. There are approximately ten million people worldwide who are blind as a result of damage to their cornea. Generating human corneas from a pluripotent stem cell source should increase the likelihood that people will receive treatment in the future even in the absence of suitable tissue from eye banks.

Lastly, the in vivo and in vitro characterization of immature hepatocyte derived from hpSC. Such cells could be used to develop a treatment for individuals with a liver that has been damaged by disease or sufferers of genetic disorders that inhibit normal liver function. In both cases, implanting healthy hepatocyte cells could treat the underlying disease and prolong the life of the individual.

These results not only show the progress we have made in these important programs, but also demonstrate the broad application of human parthenogenetic stem cells in the development of treatments for incurable diseases, says Dr. Ruslan Semechkin, Vice President of Research and Development.

The presentations will take place at the 15th Annual Meeting of American Society of Gene and Cell Therapy, in Philadelphia at 3:30 p.m. on Thursday, May 17th.

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at http://www.internationalstemcell.com or follow us on Twitter @intlstemcell.

To receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0

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International Stem Cell Corporation Scientists to Present Pre-Clinical Research Results at American Society of Gene ...

VistaGen CEO Issues Update Letter to Stockholders

SOUTH SAN FRANCISCO, CA--(Marketwire -05/14/12)- VistaGen Therapeutics, Inc. (OTC.BB: VSTA) (VSTA.OB), a biotechnology company applying stem cell technology for drug rescue, today issued the following letter to its stockholders and the investment community from its CEO, Shawn Singh.

To our valued Stockholders:

Since becoming a public company one year ago, we have progressed to perhaps the most exciting time in our company's 14-year history. To arrive at this point, more than $45 million, obtained through various strategic collaborations, investments and grant awards, has been carefully employed. We believe our pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube, combined with the network of strategic relationships we have announced, will allow us to secure additional capital and the large market drug rescue opportunities that can deliver value to our stockholders.

Since the beginning of the year, our team has carefully reviewed our Top 10 drug rescue opportunities and narrowed our focus to our Top 5 candidates. Now we intend to launch our initial drug rescue program and secure strategic capital necessary to support it, as well as launch our second drug rescue program by year-end. We also are working on validation of LiverSafe 3D, our bioassay system for drug rescue involving liver toxicity and drug metabolism issues, for launch during the first half of next year.

The pharmaceutical industry continues to face extremely high barriers in bringing new medicine to market. The number of drugs approved by the FDA over the past decade has dropped precipitously, by over 50%, in spite of staggering increases in resources devoted to R&D by pharmaceutical companies. Based on the progress we have made with CardioSafe 3D and our efforts to build our strategic drug rescue ecosystem of collaborators, we believe our core business model -- to use our stem cell technology and strategic relationships to develop less toxic variants of drugs that have already been proven in vitro to be effective -- is now more commercially promising than at any other point in our history. We believe we will be able to help major pharmaceutical companies avoid the loss of years of time and millions of dollars spent in developing new therapies that have positive efficacy data, but must be discontinued due to later discovery of unsafe toxicity levels for human heart and liver tissue.

Over the past year, we have secured additional intellectual property protection and entered into strategic relationships with leading biotech firms and academic researchers to support development of our stem technology and our drug rescue-based commercialization initiatives:

Over the next 12 months, we have an ambitious agenda to work closely with our advisors and collaborators to secure capital and achieve these transformative milestones:

Our goals are reachable, with strategic financing. We believe we have the right technology, intellectual property, development teams and specialized focus to deliver on our founding mission -- "putting humans first" -- bringing clinically relevant human biology to the front end of the drug development process, long before standard animal and human testing, and using better cells to make better medicine.

We would like to thank our partners, advisors, employees and each of you, our loyal stockholders, for helping support us in our efforts to deliver long-term value for you.

Sincerely,

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VistaGen CEO Issues Update Letter to Stockholders

Joseph Estrada defies age, shares how he did it: Stem cell therapy

By Cathy C. Yamsuan Philippine Daily Inquirer

Former President Joseph Erap Estrada had always maintained that giving generously to friends and forgiving opponents are the secrets to staying young.

But time has a way of catching up with even the most formidable leading men.

Since he entered national politics 25 years ago, Estrada has struggled with the attributes of old ageweight gain, a painful knee here, a cataract there.

He needed some kind of elixir of youth to put to right what nature has put asunder. And to get back on his feet in time to serve the people, he said which has no age limit.

So he did it, and is very open about it. What is it?

At the prodding of friends, the 75-year-old Estrada flew to Frankfurt, Germany, last month to undergo fresh cell therapy (also known as stem cell treatment), an innovative albeit controversial procedure where fresh cells from donor animals are injected into the human body to treat diseases or reverse the aging process.

Fresh cell therapy operates under the principle of like heals like.

The fresh cells from a donor animals organ are infused into the human counterpart.

Substances in the donors blood are supposed to reactivate the human bodys immune system and defense mechanism, a reaction that would eventually rebuild and revitalize aging tissues.

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Joseph Estrada defies age, shares how he did it: Stem cell therapy

Using Stem Cell Therapy For Neck And Head Cancers Avoids Salivary Gland Damage Caused By Radiotherapy

Editor's Choice Main Category: Ear, Nose and Throat Also Included In: Radiology / Nuclear Medicine;Cancer / Oncology;Stem Cell Research Article Date: 11 May 2012 - 10:00 PDT

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The researchers note this finding could enhance the quality of life of 500,000 individuals with head and neck cancer each year worldwide.

The team found that the stem cells needed for regenerating the parotid gland (the largest pair of salivary glands) were primarily located in the major ducts of the gland. According to the researchers, these cells could be easily avoided during radiotherapy or given a minimal radiation dose.

Dr. Peter van Luijk, a research associate at the University Medical Center Groningen, The Netherlands, explained:

Findings from the study were presented at the 31st conference of the European Society for Radiotherapy and Oncology (ESTRO31).

Dry mouth syndrome is a condition in which there is not enough saliva in the mouth. The condition can occur when the parotid gland stops functioning properly after radiation damage.

Symptoms of dry mouth syndrome include difficulty sleeping, eating, tooth decay or loss, and bad breath. These symptoms lead to poorer quality of life and difficulty working, as well as social isolation.

The majority of treatments to treat the condition and its consequences are insufficient and can cost hundreds or even thousands of Euros per patient each year.

Dr. van Luijk said:

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Using Stem Cell Therapy For Neck And Head Cancers Avoids Salivary Gland Damage Caused By Radiotherapy

Stem Cell Study Shows Promising Results Against Heart Failure

By Denise Mann HealthDay Reporter

THURSDAY, May 10 (HealthDay News) -- A new treatment that involves spinning bone marrow stem cells to enhance their healing potential may help people with advanced heart failure feel and function better, a small study suggests.

Researchers developed the treatment by culturing a patient's own bone marrow for 12 days. This process helped increase the amount of immune cells and stem cells that can differentiate into several different cell types, including heart cells. Those cells were then injected into heart muscle. The study was funded by treatment manufacturer Aastrom Biosciences.

According to the findings, this treatment was safe, helped repair the damaged heart muscle and reversed some heart failure symptoms, when compared to a placebo injection. The findings were to be presented Thursday at the Society for Cardiovascular Angiography and Interventions annual meeting, in Las Vegas.

The U.S. National Heart, Lung, and Blood Institute reports that about 5.8 million people in the United States have heart failure, a condition that occurs when the heart can no longer pump enough blood to meet the body's needs. Symptoms include shortness of breath, fatigue and swelling in the ankles, feet, legs and abdomen. There is no cure; treatment typically includes a cocktail of medications aimed at reducing symptoms and improving quality of life.

"A number of people with heart failure have slowly progressing disease despite medication and/or device therapy. If we could have a therapy for this group that would slow the progression of heart failure, it would be economic and change the disease process tremendously," said study author Dr. Timothy Henry, director of research and an interventional cardiologist at the Minneapolis Heart Institute at Abbott Northwestern Hospital in Minneapolis. The treatment would not be used for people who need a heart transplant.

Calling it the next generation of stem cell therapy, Henry said the treatment process helps enhance the potency of existing stem cells. "It gives a more functional product," and when injected these stem cells may promote the growth of new blood vessels, he added.

Further study is ongoing, and if the results are positive a product could be available within two years to treat inadequate blood supply to the legs, and soon thereafter for heart failure, he said. According to Henry, six or seven new products that enhance bone marrow stem cells are being developed. "Ask your doctor if you are a candidate for any of the clinical trials," Henry advised.

The new study included 22 participants with advanced heart failure and an enlarged heart whose current medication regimen was no longer effective. They either received an injection of the stem cell therapy treatment into their heart muscles or a placebo shot. After 12 months, there were no complications and no difference in side effects among those who received the stem cells and the control group. That said, individuals who received the novel stem cell therapy did have a lower number of major heart-related events and were more likely to see improvements in their ability to walk without growing breathless. Those who received the stem cell treatment also showed marked improvements in their ejection fraction, which is a measure of how much blood leaves the heart with each pump.

"This study tells us that injecting stem cells into the heart muscle of a patient with chronic heart failure may be beneficial," says Dr. Sandeep Jauhar, director of the congestive heart failure program at Long Island Jewish Medical Center in New Hyde Park, N.Y. Typically, these individuals are treated with multiple medications, put on a low-salt diet and encouraged to get some exercise.

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Stem Cell Study Shows Promising Results Against Heart Failure

In The Know: Stem cell therapy

Philippine Daily Inquirer

Former President and current Pampanga Rep. Gloria Macapagal-Arroyo, who was suffering from a mineral deficiency in her bones arising from two corrective surgeries last September, wanted to seek alternative stem cell therapy abroad.

However, she was barred from leaving the country last November after Justice Secretary Leila de Lima refused to honor the temporary restraining order issued by the high court on the inclusion of Arroyo and her husband Jose Miguel Mike Arroyo in the immigration bureaus watch list.

In the wake of Arroyos supposed plan to try the radical technology at stem cell centers abroad to cure what her doctors here described as a rare bone disease, a province mate and a colleague of the former President filed a bill to put up a stem cell center in the country.

Pampanga Rep. Carmelo F. Lazatin, a member of the minority bloc in Congress, has filed House Bill No. 5287 mandating the establishment of a research facility to explore the benefits of stem cell technology as a potential cure for incurable diseases.

Blank cells

Stem cells, the foundation of every organ, tissue and cell within the human body, are like blank cells that do not yet have a specific physiological function, according to Harvard Stem Cell Institute (HSCI).

But when proper conditions in the body or in the laboratory occur, stem cells develop into specialized tissues and organs, HSCI explains in its website, adding that there are two sources of stem cells used in research: the adult stem cells and embryonic stem cells.

Adult stem cells are found in differentiated tissues and organs throughout the body while embryonic stem cells are obtained from the inner cell mass of a blastocyst, the ball of cells formed when the fertilized egg or zygote divides and forms two cells, then again to form four and so on, HSCI said.

In 2008, the Vatican issued a sweeping document on bioethical issues titled Dignitas Personae or The Dignity of the Person, taking into account recent developments in biomedical technology and reinforcing the Churchs opposition to embryonic stem cell research, in vitro fertilization, human cloning and genetic testing on embryos before implantation.

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In The Know: Stem cell therapy

New England Journal of Medicine Reports on Three Phase III REVLIMID® (lenalidomide) Trials in Patients with Newly …

BOUDRY, Switzerland--(BUSINESS WIRE)--

Celgene International Srl, a subsidiary of Celgene Corporation (NASDAQ: CELG - News), today announced that results from three phase III studies evaluating the use of continuous REVLIMID (lenalidomide) treatment in newly diagnosed multiple myeloma (MM) patients or maintenance treatment with lenalidomide following autologous stem cell transplant were published online in the May 10, 2012 edition of the New England Journal of Medicine. All three publications highlight the expanding body of clinical evidence supporting lenalidomide treatment in these areas.

Continuous Lenalidomide Therapy (non-transplant eligible population):

The first article highlights a Celgene-sponsored study of continuous lenalidomide treatment in elderly patients newly diagnosed with multiple myeloma.

Continuous Lenalidomide Treatment for Newly Diagnosed Multiple Myeloma (MM-015)

This double-blind, phase III, multicenter, randomized study conducted by Celgene compared melphalanprednisonelenalidomide induction followed by lenalidomide maintenance (MPR-R), with melphalanprednisonelenalidomide (MPR), or melphalanprednisone (MP) followed by placebo in 459 patients aged 65 years with newly-diagnosed myeloma who were not eligible for autologous stem-cell transplant.

http://www.nejm.org/doi/full/10.1056/NEJMoa1112704

Post-transplant maintenance

The two additional articles published in the edition highlighted cooperative group studies that evaluated the use of lenalidomide maintenance following autologous stem cell transplant (ASCT).

In each of the studies, one funded by the National Cancer Institute and conducted by the Cancer and Leukemia Group B (CALGB) and one by the Intergroupe Francophone du Myelome (IFM), maintenance treatment with lenalidomide following ASCT resulted in delayed time to disease progression or death compared to placebo.

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New England Journal of Medicine Reports on Three Phase III REVLIMID® (lenalidomide) Trials in Patients with Newly ...

Study Identifies Cell Subtypes For Potential Personalized Cellular Therapies

Connie K. Ho for RedOrbit.com

A new study by researchers at the University of California, Los Angeles (UCLA) has discovered two adult stem cell-like subpopulations in adult human skin.

The findings allow for further research to be done in the area of personalized medicine and patient-specific cellular therapies.

The study, using technology from Fibrocell Science, allowed the researchers to identify and confirm two types of cells in human skin cell cultures; the possible source of stem cell-like subpopulations from skin biopsies would be faster to perform, painless, and less invasive than current extractions from adipose tissues and bone marrow.

The research, featured in the inaugural issue of BioResearch Open Access, discusses two subtypes of cells. BioResearch Open Access is a bimonthly, peer-reviewed journal. It features scientific topics like biochemistry, bioengineering, gene therapy, genetics, microbiology, neuroscience, regenerative medicine, stem cells, systems biology, tissue engineering and biomaterials, and virology.

Being able to identify two sub-populations of rare, viable and functional cells that behave like stem cells from within the skin is an important finding because both cell types have the potential to be investigated for diverse clinical applications, commented Dr. James A. Bryne, lead author of the report.

Brynes research, first at Stanford University then at UCLA, focused on reprogramming beginnings of cells from animals and then humans. A graduate of Cambridge University, Bryne studied the intra- and inter-species of epigenetic reprogramming. His work also highlighted how primate embryonic stem cells could be derived from somatic cell nuclear transfers.

The study published in BioResearch Open Access confirmed previous research that identified a rare population of cells in adult human skin that had a marker called stage-specific embryonic antigen 3 (SSEA3). Bryne and his colleagues found that there was an increase in the amount of SSEA3 expressing cells after injury to the human skin. It showed that the SSEA3 biomarker could be used to help identify and isolate cells with tissue-regenerative traits.

Finding these rare adult stem cell-like subpopulations in human skin is an exciting discovery and provides the first step towards purifying and expanding these cells to clinically relevant numbers for application to a variety of potential personalized cellular therapies for osteoarthritis, bone loss, injury and/or damage to human skin as well as many other diseases, remarked Byrne, an Assistant Professor of Molecular and Medical Pharmacology at the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA.

Bryne and his team used Fibrocell technology to collect cells from skin samples, cultured the cells in the lab, and purified them by fluorescence-activated cell sorting (FACS). The FACS tagged suspended cells with fluorescent markers for undifferentiated stem cells. The researchers were able to separate the rare cell subpopulations from other kinds of cells.

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Study Identifies Cell Subtypes For Potential Personalized Cellular Therapies

2 Cell Transplantation studies impact dental stem cell research for therapeutic purposes

Public release date: 8-May-2012 [ | E-mail | Share ]

Contact: David Eve celltransplantation@gmail.com Cell Transplantation Center of Excellence for Aging and Brain Repair

Tampa, Fla. (May. 8, 2012) Two studies appearing in a recent issue of Cell Transplantation (20:11-12), now freely available on-line at http://www.ingentaconnect.com/content/cog/ct/, evaluate stem cells derived from dental tissues for characteristics that may make them therapeutically useful and appropriate for transplantation purposes.

Induced pluripotent stem cells from immature dental pulp stem cells

A Brazilian and American team of researchers used human immature dental pulp stem cells (IDPSCs) as an alternative source for creating induced pluripotent stem cells (iPSCs), stem cells that can be derived from several kinds of adult tissues. According to the study authors, production of iPSCs "opens new opportunities for increased understanding of human genetic diseases and embryogenesis" and will likely have a "great impact on future drug screening and toxicology tests."

The authors note, however, that the reprogramming methodology for making iPSCs is relatively new and "needs refining" in terms of technique, efficiency and cell type choice.

The researchers report that they easily, and in a short time frame, programmed human immature dental pulp stem cells into iPSCs with the hallmarks of pluripotent stem cells.

"Human IDPSCs can be easily derived from dental pulp extracted from adult or 'baby teeth' during routine dental visits," said study lead author Dr. Patricia C.B. Beltrao-Braga of the highly ranked National Institute of Science and Technology in Stem and Cell Therapy in Ribeirao Preto, Brazil. "hIDPSCs are immunologically privileged and can be used in the absence of any immune suppression protocol and have valuable cell therapy applications, including reconstruction of large cranial defects."

Contact: Dr. Patricia C.B. Beltrao-Braga, National Institute of Science and Technology in Stem Cell and Cell Therapy, 2051 Tenente Catao Roxo St. Ribeirao Preto, Brazil. Tel. 55 (11) 3091-7690 Email patriciacbbbraga@usp.br

Citation: Beltro-Braga, P. C. B.; Pignatari, G. C.; Maiorka, P. C.; Oliveira, N. A. J.; Lizier, N. F.; Wenceslau, C. V.; Miglino, M. A.; Muotri, A. R.; Kerkis, I. Feeder-free derivation of induced pluripotent stem cells from human immature dental pulp stem cells. Cell Transplant. 20(11-12):1707-1719;2011.

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2 Cell Transplantation studies impact dental stem cell research for therapeutic purposes

Stem cell collaboration could set stage for company’s growth

A stem cell breakthrough at UCLA could mark a big step for a biopharmaceutical company to use its proprietary technology to forge partnerships with pharmaceutical companies and other research institutions.

Fibrocell Sciences technology isolates, purifies and multiplies a patients fibroblast cells, connective skin cells that make collagen. In a research collaboration with the company, UCLA used the technology to isolate, identify and increase the number of different skin cell types, which lead to two rare adult stem cell-like subpopulations being identified in adult human skin SSEA3-expressing regeneration-associated cells associated with skin regeneration after injuries and mesenchymal adult stem cells.

The findings could have broad applications for personalized medicine. Currently, adult stem cells are derived from adipose tissue and bone marrow. Using mesenchymal stem cells would be less invasive and could be more efficient. Mesenchymal stem cells are being used in research to develop osteoblasts, or bone cells; chondrocytes, or cartilage cells; and adipocytes, or fat cells.

David Pernock, the chairman and CEO of Fibrocell, said the move could mark a significant step in the companys growth.

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Pernock added: Once we have shown we can produce these stem cells in meaningful quantities safely and efficiently, I think well be in a position where companies would want to partner with us to develop them for a variety of indications.

In addition to collaborations, the company has been developing its own therapeutics.

The company is poised to launch its first U.S. Food and Drug Administration-approved therapy Laviv. The therapy uses individuals fibroblast cells to reduce nasolabial fold wrinkles, folds on both sides of the face that start from the outer corners of the nose down to the corners of the mouth. It is also advancing its acne therapy through phase 3 clinical trials and its burn scar therapy through phase 2 trials.

Pernock joined the company two years ago from GlaxoSmithKline. He said the developments under way at the company indicate it is growing and expects to add engineering staff to its Exton, Pennsylvania office later this year.

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Stem cell collaboration could set stage for company’s growth

Pluristem stem cell therapy saves a patient, shares jump

Wed May 9, 2012 3:35pm BST

(Reuters) - Pluristem Therapeutics Inc said a 7-year old girl suffering from a bone marrow disease experienced a reversal of her condition after receiving its experimental stem cell therapy, sending the Israeli company's shares up 32 percent.

The girl, suffering from aplastic bone marrow in which the patient has no blood-forming stem cells, had a significant rise in her red cells, white cells and platelets following an injection of Pluristem's therapy -- PLacental eXpanded cells.

"The results of this unique case indicate that PLX cells may be effective in treating other diseases that affect the bone marrow," Reuven Or, the child's physician at Hadassah Medical Center, was quoted in a statement by Pluristem.

Last September, the company said animal studies showed that the therapy had the potential to treat blood tissue complications related with acute radiation syndrome, commonly called radiation sickness.

Last month, the U.S. health regulators gave a go ahead to the company to start a mid-stage trial of the therapy for treating Intermittent Claudication -- a subset of peripheral artery disease.

Pluristem shares, which have gained 5 percent since receiving the FDA nod for the mid-stage trial, were up 15 percent at $2.70 in morning trade on the Nasdaq. They touched a high of $3.10 earlier.

(Reporting by Esha Dey in Bangalore; Editing by Gopakumar Warrier)

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Pluristem stem cell therapy saves a patient, shares jump

Neuralstem Updates ALS Stem Cell Trial Progress

ROCKVILLE, Md., May 8, 2012 /PRNewswire/ --Neuralstem, Inc. (CUR) announced that the Federal Drug Administration (FDA) has approved the return of three patients from earlier cohorts in its ongoing Phase I safety trial to treat amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) with its spinal cord stem cells (HSSC's). These patients will be permitted to return to the trial for second treatments as the next cohort of patients, provided they meet inclusion requirements at the scheduled time. They will be the first to receive stem cell transplantation along the length of the spinal cord.

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The first twelve patients in the trial, which is taking place at Emory University Hospital in Atlanta, Georgia, received stem cell transplants in the lumbar (lower back) region of the spinal cord only. Thelast cohort of three, completed in April, received transplants in the cervical (upper back) region of the spinal cord, where stem cell transplantation could help support breathing, a key function that is lost as ALS progresses. The next cohort of three patients is designed to receive 10 HSSC injections in the lumbar region and 5 in the cervical, for a total of 15 injections along the length of the spinal cord. In the case of the returning patients, who have already received 10 lumbar injections, they will receive five cervical injections. These patients are between 15-17 months out from their first dosing and appear to have tolerated the first procedure well.

Additionally, Neuralstem has submitted a trial amendment to the FDA to increase both the number of patients treated as well as the dose in future cohorts. The amendment would also expand the trial to include certain efficacy endpoints. The trial was initially designed as a safety trial to treat 18 patients.

"The return of these patients to the trial for second treatments is a continuing validation of the trial's safety. Typically, Phase I trials do not bring study subjects back, as that could increase their exposure to potentially harmful treatments," said Karl Johe, PhD, Neuralstem Chairman and Chief Scientific Officer. "Treating these patients who have already received injections in one part of their spine allows us to both increase the overall dosage for each patient as well as transplant them in regions of the spine where they have not been treated," Dr. Johe continued. "Thisnext cohort of patients will be the first in the world to receive stem cell transplants in both cervical and lumbar regions of their spinal cord. With cervical injections of the lumbar patients, for example, we could also potentially support their breathing function, which is vital for preserving quality of life."

"Patients 10-12, who might return to the trial, were among those studied in a paper examining the first safety data from the trial, published online in STEM CELLS last month," said Eva Feldman, MD, PhD, Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health System. "As the paper showed, we believe that the cells and the route of administration are safe. It is a further validation of the safety profile to be able to bring patients back for additional dosing several months past the period which was reported on in the journal." Dr. Feldman is also principal investigator (PI) of the ALS trial and an unpaid Neuralstem consultant.

The FDA-approved amendment to the protocol requires approval of the Emory Institutional Review Board before it can be implemented.

About the Study

The ongoing Phase I study is designed to assess the safety of Neuralstem's spinal cord stem cells (HSSC's) and transplantation technique in up to 18 patients with amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease).

The first twelve patients were all transplanted in the lumbar (lower back) region of the spine. Of these, the initial six (Cohort A) were all non-ambulatory with permanent paralysis. The first patient was treated on January 20, 2010. Successive surgeries have followed at the rate of one every one-to-two months. The first three patients (Cohort A1) were each treated with five unilateral HSSC injections in L2-L4 lumbar segments, while the next three patients (Cohort A2) received ten bilateral injections (5 on each side) in the same region. The next six patients (Cohort B and C) were all ambulatory. Of these, the first three (Cohort B) received five unilateral injections in the L2-L4 region. The last three patients (Cohort C) in this study group received ten bilateral injections in the same region.

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Neuralstem Updates ALS Stem Cell Trial Progress

TiGenix : presenting at Key Conferences – Spring 2012

Regulated information May 8, 2012

TiGenix to Present at Key Conferences Spring 2012

Leuven (BELGIUM) - May 8, 2012 - TiGenix (TIG.BR), a leader in the field of cell therapy, announced today that during the months of May and June the company will present at a number of key events in Europe and the U.S. geared at investor, industry, and academic audiences to highlight the commercial potential of ChondroCelect, the only approved cell therapy in Europe, and of the company`s innovative proprietary allogeneic stem cell platform with programs in Phase I, II, and III for a range of inflammatory and autoimmune diseases.

May 15-16 BioEquity, Marriott Hotel, Frankfurt, Germany Presenter: Eduardo Bravo, CEO Date & time: Tuesday, May 15, 16:00-16:25 Room: Level 1, Room Gold 1

May 21-23 World Stem Cells and Regenerative Medicine Congress, Victoria Park Plaza, London, UK Presenter: Eduardo Bravo, CEO Date & time: Monday, May 21, 15:25 -15:50 Title: Cell Therapy & Regenerative Medicine - Progressing into phase III with an orphan indication

May 24 Knowledge for Growth, ICC Ghent, Belgium Presenter: Eduardo Bravo, CEO Time: 11:30 Keynote speech - Advanced therapies: this time it is for real

June 5-8 18th International Stem Cell Therapy Sociey Annual Meeting, Sheraton Seattle, WA, U.S. Presenter: Eduardo Bravo, CEO Date & time: June 7, 13:45-15:15 Title: Plenary Session 4 - Regenerative Medicine and Positioning for Commercial Success - Lessons from the commercial roll out of ChondroCelect in Europe

June 18-21 BIO International Convention, Boston Convention & Exhibition Center, MA, U.S. Presenter: Eduardo Bravo, CEO Date & time: June 20, 15:00-15:45 Title: Stem Cell Therapies...Fact or Fiction?

June 23 VFB Biotech Congres, Leuven, Belgium Location: Imec, Kapeldreef 75, Leuven Presenter: Gil Beyen, Chief Business Officer Time: 11am

June 23 Dag van de Biotechnologie, Leuven, Belgium Location: TiGenix headquarters, Leuven Event: Open day event throughout Flanders for all biotech companies & academic labs Time: 10am-5pm

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TiGenix : presenting at Key Conferences - Spring 2012

Treatment spares Lebanon man from amputation

LEBANON Retired Dartmouth College professor Roger Smith said he had nothing to lose by joining a stem cell therapy clinical trial. In fact, if he didn't join, he did have something to lose possibly his leg.

In the end it appears the experiment saved his leg. And Smith, who'd already lost two toes to amputation, said he's proud to have played a part in a study that could dramatically improve the outcome for many other patients facing lower-limb amputations resulting from diabetes, high cholesterol, smoking, genetic predisposition and other causes.

The three-year study that ended last year was led by vascular surgeons at Dartmouth-Hitchcock Medical Center in Lebanon, who believe the treatment may offer new hope to sufferers of peripheral artery disease, a condition that causes nearly 60,000 lower-limb amputations every year.

Dr. Richard J. Powell, chief of vascular surgery at Dartmouth-Hitchcock, was the lead investigator of the second-phase national study, which included 72 patients from 20 different sites across the United States.

It's a winner, Powell said. For me, it was dramatic, because there has been nothing that has been shown to work. The results of the third-stage trial are to be presented to the Food and Drug Administration to be approved as a treatment for patients, Powell said.

Peripheral artery disease afflicts more than 9 million patients in the United States, according to Dartmouth-Hitchcock. The condition results from blockages in blood vessels caused by atherosclerosis hardening of the arteries. Options for these patients are limited to the insertion of stents or bypass surgery.

And for about 150,000 patients in the United States who have the most severe form of the disease, amputation is the only option. The results of this recent study suggest amputation could be prevented in the majority of these severe cases.

And if the third phase of the clinical trials confirms the earlier results, the lives of those patients with severe cases could be tremendously affected, Powell said.

This is the first potential treatment that is non-surgical for really severe cardiovascular disease in the legs, he said. Roger Smith's story

About six years ago, Smith, 79, said he was having pain in his leg and trouble sleeping. He was initially misdiagnosed as having the nerve-related condition referred to as spinal stenosis, more commonly known as sciatica. When his condition worsened, he was correctly diagnosed with advanced peripheral artery disease. He lost two of his toes to amputation and was in danger of losing his leg.

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Treatment spares Lebanon man from amputation