For pain doctor Mark Wallace, arthritis meant his hobby of competitive swimming was becoming too painful.

Every stroke was like an ice pick in my shoulder, said Wallace, chief of the division of pain medicine at UC San Diego. Cortisone shots relieved the pain for about a month, and then it would return.

For philanthropist Denny Sanford, even walking was too painful. He sought relief for his arthritis with a right knee replacement, but that didnt work well. So to treat his other knee, he looked for an alternative.

Wallace and Sanford said they found that relief with stem cells; Wallace at UC San Diego using cells from his bone marrow, and Sanford at a clinic in Germany using cells from his fat tissue. Their cases particularly Wallaces illustrate how the use of stem cells to relieve joint pain is becoming an accepted part of orthopedic medicine.

With millions of baby boomers experiencing the miseries of arthritis, the need is great and growing. However, the zoo of stem cell treatments is confusing. Outside of legitimate clinical trials, outright quackery proliferates. And legitimate or not, insurance generally doesnt cover these treatments, which can cost several thousands of dollars, or even tens of thousands of dollars.

Those looking for legitimate stem cell treatments face bewildering choices about where to go and which of the many kinds of stem cells are best for their condition.

Arthritis sufferers need to be realistic about what stem cells can do, said Dr. William Bugbee, an orthopedic surgeon who practices at Scripps Health. They may experience a relief in pain, but again they might not. And patients who expect stem cells to regenerate their deteriorated joints will be disappointed.

There's a whole gamut of things that fall under regenerative medicine, Bugbee said. But there's really nothing scientifically proven to regenerate tissue, particularly in arthritic joints. So the term regenerative medicine is sexy, but it doesn't really describe what we can do clinically.

That said, pain relief in itself is a major achievement in those with arthritis.

There is a huge business to manage arthritic pain in patients that don't need a new knee or knee replacement, Bugbee said. And we have very few effective long-lasting treatments and certainly no treatments that slow the progression of the disease. So there's a huge need. So these treatments like stem cells are filling a void for people who want to get symptom relief.

Bugbee said he cautions patients keep their expectations in check.

I would say this might provide you some symptom relief, you might get a few months or six months or a year of relief, but you might not. And I don't know that it's better than giving you a cortisone shot, Bugbee said. But some people respond. And so it's worth it if they've tried other options and they don't really want to have surgery yet.

Scores of therapies derived from stem cells are in clinical trials in the United States. While some have shown promising results in experimental testing, none have yet been approved by the U.S. Food and Drug Administration.

However, doctors have the authority to perform certain kinds of stem cell treatments on their own. These involve autologous cells, taken from the patient, and minimally manipulated. Doctors separate the desired cells, such as by spinning them in a centrifuge, and then re-injecting these same cells at the point of treatment.

But the precise definition of what doctors can and cant do is unclear, leaving a gray area where doctors act on their own. In some cases, the outcome is tragic. Three people with macular degeneration were left blind after being treated at a Florida stem cell clinic with their autologous cells. Moreover, the trials were registered with a web site called clinicaltrials.gov, a service of the National Institutes of Health. The NIH doesnt fully vet these trials for scientific soundness.

The orthopedic use of stem cells to relieve joint pain falls on the legitimate side of this gray area, said Bugbee and Paul Knoepfler, a stem cell researcher at UC Davis.

Knoepfler said a reputable academic medical center such as UC San Diego is a good place to look for legitimate treatment. Also, patients should consider what kind of stem cells are to be used, and whether its reasonable to expect they have the power to treat the condition. This is a principle called homologous use, he said.

Using stem cells derived from bone marrow to treat arthritis fits the homologous use principle, Knoepfler said. But injecting those cells into the brain to treat autism would not, he said.

In addition to his aching left shoulder, UC San Diego pain physician Wallace suffered from a strained medial collateral ligament on the inside of his right knee that had never healed. He sought relief from another pain doctor at the university, Jeffrey Chen.

When Chen told colleagues he was taking volunteers for a stem cell treatment, using a centrifuge he was testing, Wallace jumped at the chance. Bone marrow was extracted from his left hip, processed through the centrifuge, and the separated cells injected into the painful joint and the knee ligament.

Some inflammation resulted, and the pain actually got somewhat worse for a week, Wallace said. The cells initially cause inflammation, hence the pain.

After a week it went back to baseline, Wallace said. And then each week was getting better and better and better. It took about four weeks and then I was doing breast stroke kicks and I had very little pain in my shoulder. Now it's been over two years.

Wallaces positive response couldnt have be predicted, Chen said. Some patients get no relief, some do.

To improve results, doctors are experimenting with different approaches, different kinds of centrifuges, different combinations of cells, sometimes including non-stem cells that help the pain relief process.

People are getting relief, Chen said. But you have to make sure it's consistent and that the mechanism is understood.

Inflammation is a necessary part of the healing cascade, Chen said. Steroids suppress inflammation, providing temporary relief at the expense of slowing down long-term healing.

Were trying to shorten that healing cascade, Chen said. We actually want some inflammation in there so it actually heals. This is one of the ways that potentially could do that for us.

Denny Sanford, the philanthropist who got stem cell therapy for his left knee, likewise said that it worked for him, actually regenerating some cartilage.

Sanford went to a clinic in Munich, Germany operated by Sanford Health, one of the beneficiaries of his philanthropy. As in Wallaces case, the cells were also autologous, but from a different source, Sanfords adipose or fat tissue.

Sanford spoke about the results at a recent conference in San Diego on the use of stem cells for orthopedic purposes.

I had a full mechanical knee put in on the right side, and it was absolutely, horribly painful, Sanford said. I didnt want to go through that again.

Besides the ongoing pain, the mechanical knee makes an annoying clicking sound when walking, Sanford said. The procedure in Germany was simple by comparison, he said, and recovery time and results were superior.

Three months recovery on the mechanical knee, three weeks on the stem cell knee, Sanford said. Today, the pain is virtually nonexistent in the stem cell knee versus the mechanical knee. It works beautifully. And its been year and a half.

Sanford said in an interview that Germanys regulations allow better access to these therapies than in the United States, and noted athletes such as golfer Jack Nicklaus have gone there.

One of the things that made procedure attractive was the low risk of using the stem cells, Sanford said.

They may not do anything, but in my case they have, he said.

Dr. Darryl DLima is director of Orthopedic Research at Scripps Healths Shiley Center for Orthopaedic Research and Education. He says clinical trials vary in scientific validity, and patients should keep those differences in mind.

The most valid studies randomly assign patients to either receive the experimental therapy or not, so differences among the two patient group and control group are likely related to the treatment, DLima said.

In the stem cell world, these studies are relatively few.

I would say 80 to 90 percent of so-called clinical studies are lower-level studies classified as cohort studies, DLima said.

These studies arent approved by the FDA, but are authorized by a review board from the institution giving the therapy.

The problem is that they don't have control groups, DLima said. The patient is his own control. They document the patientss clinical condition before the treatment and then document the patient's clinical condition after the treatment. Most of the studies are fairly loosely designed and there's no active (effort) to get the patients back for follow up.

Patients should also consider the kinds of cells to be used, because some are higher risk than others, DLima said. Autologous cells are the safest, because theyre the patients own cells.

The most risk comes from using tissues grown from embryonic stem cells or a man-made equivalent called induced pluripotent stem cells. Thats because pluripotent stem cells can make nearly any type of tissue in the body. So any remaining pluripotent stem cells in transplanted tissues tend to form tumors called teratomas, disorganized masses of random tissue types, such as hair, brain, liver and bone. For these trials, FDA authorization is required.

Intermediate on the risk level are non-pluripotent stem cells, such those found in bone marrow or fat, taken from other people. The FDA must also approve these trials.

Lisa Kadyk, senior science officer for the California Institute for Regenerative Medicine, the states stem agency, listed a number of warning signs that a stem cell treatment might not be legitimate.

-- Slick websites and hyped claims of effectiveness

-- Large out-of-pocket costs to patients

-- Small stand-alone clinics not associated with hospital networks or other high profile medical groups

Kadyk said patients can get more extensive guidance from the International Society for Stem Cell Research. Go to j.mp/stemle for the information.

Using cautious wording, Kadyk said by email that it is possible that some autologous therapies, such as bone-marrow derived cells for arthritis, could produce a therapeutic benefit in some situations.

This possibility would explain anecdotal stories of benefit maybe sometimes these treatments really are helping patients, and in other cases they are not, Kadyk said.

A simple explanation for the difference in response is that one persons stem cells may not be as healthy or as able to repair as another persons stem cells, she said. This can be due to their genetic makeup, or simply due to aging as one ages, ones stem cells age as well, and become less functional. Or, the differences could be ascribed to differences in how the cells are isolated, how they are treated after isolation, and how they are administered back to the patient.

With unregulated therapies, there is no standard for any of this, so patients are taking a gamble, rather than having some assurance that the methods used have been proven to work effectively, she said.

bradley.fikes@sduniontribune.com

(619) 293-1020

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