Stem-cell transplants are only approved for a handful of rare conditions—but
that hasn’t stopped for-profit clinics from using them for a host
of cosmetic and medical issues, including orthopedics.
A website for five affiliated
stem-cell clinics hails a “breakthrough” for Parkinson’s disease: “Stem
Cells Replace Damaged Nerves, Reverse Symptoms.” Another promotes,
“Regenerative treatments with stem cells, growth factors, and platelet-rich
plasma that are non-steroidal and outpatient” and promises to, “repair
and regenerate damaged tendons, ligaments and cartilage from arthritis
or sports injuries. Hair restoration and Platelet Rich Plasma Face-lifts
too!!!” As a further incentive, “insurance MAY cover the cost
of Stem Cell Therapy for numerous arthritic conditions and soft tissue
For those of you whose lives—or whose loved ones’ lives—have
been upended by chronic or
incurable conditions such as Parkinson’s, that’s just the kind of breakthrough you’ve been waiting
for. But here’s some advice about these and other for-profit
stem-cell treatments that you probably don’t want to hear:
“Steer clear of them. They’re probably taking advantage of
you and it’s probably unproven,” says Lawrence Goldstein,
director of the
Sanford Stem Cell Clinical Center at UC San Diego Health.
Stem-cell science is a relatively new field. Stem cells hold
great potential for medicine because of their ability to develop into different types
of cells in the body, and to repair and renew tissue. But so far, the
only stem cell-treatments approved for wide use in the U.S. involve transplants
from bone marrow or blood for patients with certain cancers and other
disorders, says Sidney Golub, director of the Sue and Bill Gross
Stem Cell Research Center at the University of California, Irvine.
Meanwhile, dozens of experimental stem-cell treatments are being tested
across the country in clinical trials on human subjects. “There
are some really exciting developments showing great promise, but they
are unproven at present,” Golub
says. If most stem-cell therapies are unproven, how is it that nearly 600 clinics across the country offer costly stem-cell treatments for both cosmetic and medical purposes,
ranging from spinal-cord injuries to
California has 113 of these clinics, more than any other state, according
to stem-cell researchers
Leigh Turner of the University of Minnesota and
Paul Knoepfler of the University of California, Davis. Florida comes in second with 71,
followed by Texas with 37. Many of these clinics say they use stem cells
derived from patients’ own fat and, for related reasons, argue that
their treatments are exempt from the U.S. Food and Drug Administration’s
rigorous approval process. Others utilize a Regenokyne system, which although
in use in Europe is not clearly FDA approved in the USA. It utilizes a
system of blood centrifugation. Another system provides concentration
of bone marrow aspirated from the pelvis. All are of questionable effectiveness.
Their websites show heart-wrenching
testimonials from patients who have undergone treatments and believe they have benefitted.
The treatments can cost $15,000, $25,000 or more, and generally aren’t
covered by health insurance.
If you’re swayed by the testimonials, if you’ve tried every
other treatment, and even if you have the money to burn, you should still
steer clear, experts say. “If somebody is telling you something
that’s too good to be true, it’s too good to be true,”
In addition to spending thousands of dollars on a therapy that may not
help, you could experience undesirable medical side effects, they warn.
The risk is far greater than the potential benefit,” says Mary Bass,
director of public policy at
Americans for Cures, a patient advocacy group that supports stem-cell research for chronic
diseases and injuries. “There are really no shortcuts in the scientific
discovery process. Shortcuts come at grave cost to patients’ health,
now or down the line,” Bass says.
The Food and Drug Administration, too, said in a statement for consumers
that it is “concerned” that patients may be “vulnerable to unscrupulous providers
of stem-cell treatments that are illegal and potentially harmful.”
Kevin McCormack, director of patient advocate outreach for the
California Institute for Regenerative Medicine (CIRM), the state’s stem-cell agency, acknowledges that patients
don’t want to hear this kind of advice. “They’ve often
explored every other option and don’t have anything left,”
But there may be something you can do, he says: Search for a scientifically
sound clinical trial that is testing a stem-cell therapy for your condition.
One trustworthy place to look, McCormack says, is the
Alpha Stem Cell Clinics Network—three clinics in Southern California specializing in stem-cell clinical
trials that are funded by CIRM. They have more than
20 trials underway for conditions ranging from HIV to ovarian cancer, he says. “If
there’s something at one of those clinics, you know it’s legitimate
and as safe as can be,” McCormack says.
To find other stem-cell clinical trials, start with the government-runclinicaltrials.gov database. But be cautious. Some for-profit stem-cell clinics post on that
site, and patients who want to participate in their “studies”
must pay for the cost of the treatment. If you identify a trial that might fit
your situation, do some digging, says Cathy Danielson,
a stem-cell patient advocate based in Oregon.
“Start asking questions, start posting on online forums,” she
says. “Ask who funded it. Follow the money.”
Goldstein urges patients to look for trials that are conducted by academic
medical centers or nonprofit medical institutions, and to ask study sponsors
if they have received FDA approval for their trials. “Patients will
recognize legitimate clinical trials because, in general, they won’t
be charged for the cost of the treatment,” he says.
Finally, if you find a trial, there’s no guarantee you’ll receive
the experimental stem-cell treatment. That’s because in most trials,
some participants—chosen randomly—will receive either a placebo
or the current standard of care, while others will get the experimental
treatment. In other words, there are obstacles to obtaining stem-cell
therapy at this point. Remember that, until clinically proven and reproducible
in multiple different trials, a remedy is simply a placebo effect.
Although exciting, there are precious few studies in peer-reviewed journals
that show a clear cut positive effect from injecting platelet rich plasma,
stem cells or other concentrates of patient-derived cells. Presently,
any concentrate that is injected has a positive effect on a patient only
if the patient “truly believes” that the injection has worked.
Spend your hard-earned dollars accordingly.