StemGenex CSO Tells FDA at Hearing to Regulate Adult Stem Cell Therapies as ‘Blood Tissue Product’

StemGenex CSO Tells FDA at Hearing to Regulate Adult Stem Cell Therapies as ‘Blood Tissue Product’

In a presentation at a U.S. Food and Drug Administration (FDA) public hearing earlier this month, the chief scientific officer of StemGenex Medical Group, Steven A. Brody, MD, PhD, said succinctly: “Stem cells have arrived and have captivated the scientific and medical communities. With this excitement comes responsibility and with this responsibility comes regulation.”

Steven Brody
Dr. Steven Brody (Courtesy of StemGenex)


The purpose of the FDA hearings, held at National Institutes of Health (NIH) facilities in Bethesda, Maryland, on Sept. 12–13, was to obtain comments on four Draft Guidances of Human Cells, Tissues and Cellular and Tissue-Based Products relating to the regulation of adult stem cell therapies from a broad range of stakeholders, including  healthcare professionals, clinicians, biomedical researchers, patients, tissue establishments, biological and device product manufacturers, and the public.

The FDA asked for feedback on the scope of its draft guidelines, ranging from the particular topics covered and questions posed, to the identification of additional issues not covered but for which guidance would be helpful, and whether the FDA’s recommendations for each topic were sufficiently clear and consistent to provide meaningful guidance.

The nearly 500 event attendees heard presentations from approximately 90 speakers, many whom advocated relatively open access to adult stem cell therapies. But others maintained that adult stem cells should be regulated as a drug, to allow for the rigorous scientific screening that new drugs are required to go through, a process that evaluates both their safety, efficacy and proper dosing so as to limit potential harm and unknown outcomes to patients receiving them

Paul Knoefpler, a stem cell researcher at the University of California, Davis, is a strong advocate for strict FDA regulation. On his blog, The Niche, Knoefpler writes: “As a scientist who studies and worries a great deal about the tumorigenicity of stem cells, I personally think the FDA is doing its job of being extremely careful about the safety of stem cell-based drugs and the need for compelling pre-clinical safety data.”

Paul Knoepfler
Paul Knoepfler

In another blog entry, Knoefpler — who began his blog in 2009 while recovering from prostate cancer surgery — also argues that stem cell therapies are indeed the equivalent of drug therapies. “Stem cells are drugs and possibly permanent ones,” he writes in a June post. “Yeah, stem cells can be extremely unusual drugs, but they are often drugs even if some argue they aren’t. … Unlike other drugs, once a patient receives a stem cell drug, it will not necessarily simply go away like other drugs because a stem cell drug consists of living cells that often behave in unpredictable ways. What this means is if the stem cells are doing bad things your doctor has no way to stop it. You have no way to stop it.”

Knoefpler adds: “I am as excited as anybody about the potential of stem cells to treat a whole bunch of diseases and injuries, but they are not some kind of miracle cure for everything. When a doctor offers to inject some kind of stem cells into a patient … we just do not know at this point if it will do any good with the exception of bone marrow transplant.”

A drug approval process, however, could delay patient access to stem cell therapies for years, StemGenex argues, noting that the regulatory pathway to market authorization for a new drug, under favorable circumstances, can take some 10 to 15 years and a cost of tens of millions of dollars.

StemGenex, based in La Jolla, California, specializes in regenerative medicine and adult adipose stem cell therapy, emerging fields of medicine which, the company says, can help people with unmet clinical needs. Physicians at its treatment center offer stem cell therapy procedures to applicable patients requesting them. StemGenex is also currently sponsoring five clinical trials  in patients with multiple sclerosis, Parkinson’s disease, rheumatoid arthritis, chronic obstructive pulmonary disease (COPD), and osteoarthritis, evaluating quality of life changes in people with these diseases who have received adipose tissue-derived stem cell treatment.

In his presentation, Brody, who specializes in regenerative and restorative medicine, and who has expertise in endocrinology and metabolism, gynecology, and reproductive medicine, asked the FDA to consider three changes, in particular, as it proceeded with finalizing the new guidances:

  1. Recognize the structural and non-structural properties of adipose tissue
  2. Review and expand the definition of minimal manipulation
  3. Regulate human cells, tissues, and cellular and tissue-based products in the same manner as blood tissue products, and within the existing comprehensive standards of organizations such as the American Association of Blood Banks (AABB)

“Organizations such as the AABB are ideally suited to safely guide and regulate the use of adipose-derived stem cells,” Brody said in a press release. “The AABB established regulatory framework would require stem cell treatment centers to meet standards that would ensure public safety.”

StemGenex’s position on stem cell therapy regulation is that amending the draft guidances as related to Brody’s recommendations would constitute a positive step in providing medical professionals with the ability to offer their patients a properly regulated but promising treatment option, particularly in instances where there is little hope.

Ed Tobias, an MS patient and columnist for Multiple Sclerosis News Today, also takes a look at this month’s FDA stem cell hearing in his column,”Packed House at FDA Stem Cell Hearing,” published today.

As Tobias and the FDA note, public comments into stem cell therapy and its regulation are welcome from the interested public — which certainly includes patients, family members and caregivers — through the close of Tuesday, Sept. 27, on an FDA website for comments (click on “Comment Now” blue button in the upper right corner).


  1. Adrian Sohn says:

    I am thinking of getting an MS treatment from StemGenex. I am not worried about the stem cells as they are from my own body. On one hand I don’t se how it can possibly work for me with 20 years hx with ms.
    On the other hand I see on Facebook and have spoken with the stemgenex doctor Dr Andre Lalonde and think that the possible benefits greatly outweigh the risks.
    I’ve seen no adverse effects from Stemgenex treatment and many claimed benefits
    I am a family doctor and below is my clinic’s website

    • Brandon says:

      Adrian I would strongly advise you to not spend your money on the Stemgenex treatment. Particularly for MS.
      Only stem cell transplant showing benefits in MS is HSCT (hematopioetic stem cell transplant). Because HSCT uses lighter chemotherapy to stop your immune system from attacking itself.
      Then you get your stem cells back to build a new immune system.
      Stemgenex does nothing to stop the underlying problem with MS, just offers people false hope and takes their money.
      Please do some research on HSCT for MS, it’s being preformed in the US and many other counties successfully and with great results. I don’t know your situation but if you have MS as I do, I can tell you to please look into HSCT.

        • Philip Irwin says:

          I just had a procedure called TVAM from a clinic in CA (Autonomic Specialists). I also had a stem cell treatment. The stem cell treatment I received is a little different then what StemGenex does. I looked into both but Autonomic Specialists was about $10k less so I went with them and also was able to get the TVAM procedure. Being only a week since I had this done I am already noticing an improvement. I have more energy and I am sleeping better. I had severe spasticity in my legs and it is showing signs of improvement. There is less pain and my walking has also improved. Not sure if it is just me being hopeful or it is actually working this quick but I think it was money well spent.

          • Adrian Sohn says:

            That is encouraging to hear Phillip.
            I’vethoughtfor over 1 yr bout going to Stemgenex in California.
            My neurologist says its a waste of $$
            “go on a holiday wth your wife, they cant do what they say they will. Its just not possible!
            You’ve had MS for 20 years, they cant change the damage that has been done!
            He’s a very educated man who reads all the latest studies no bad will in him, just the hoe for my best.
            I’d love to hear more of your progress!
            ps that website is a tribe of people I’ve known for 30 years! I’m the guy near the water

          • Philip Irwin says:

            My neurologist said the same thing. They are medical doctors and they make their money by giving you meds. If there is a cure for your condition I am not sure some doctors try to shy away from it. I have been told by 2 different doctors to not do it since there was not enough tests done on stem cells yet. I decided to do it anyway, because I needed to do something. The spasticity in my leg was getting so bad, I was only getting about 2 hrs of sleep at night and I had serious issues walking. Just after a week, I am getting way better sleep and I have greatly reduce my consumption of Baclofen and the spasticity and weakness in my leg has greatly improved. The point of stem cells is to fix those damaged cells, so I don’t think it matters how long you have had MS, I think it can still work. I have had MS for about 10yrs.

          • Adrian says:

            Thank you Phillip
            I’ve had ms for 20 years
            I don’t think my neurologist is just trying to push drugs
            If there was a good study showing Stemgenex works he’d be all for it
            But still I’m going to do it!
            I’ll tell you how it goes

  2. erik oxy says:

    Hello , I have been very very interested in the kind of stem cell therapy provided by stemgenix, and I have been accepted and spoke to them unfortunately the cost is greater then I could ever afford. I live in Kansas and I did have as company in Kansas that provides the same service, The Kansas Regenerative Clinic. They are cheaper but Medicare obviously won’t cover it

  3. Courtney says:

    That’s the issue with all the stem cell treatments even though it is a study the cost is only affordable by the rich. So those of us that fight for our money have no chance.

  4. Shaun says:

    Hello to all of my fellow people who suffer the same problems. I have used a swiss company and recieved stem cells for my 9yrs progressive MS. My condition has greatly improved and 7mths on I am still seeing improvements. I am from the uk & my neurologist says negative things and advises against it. Well he doesn’t have to live with the horrible effects of this disease and I can’t afford the time that the rest of the world is taking to cathe up. 25,000 euros well spent for me and I can 100% recommend it to anyone else. Let the drug companies disregard this treatment afterall it’s they that will lose out. The uk are suggesting chemo 1st, no surprise that they will still be able to make a profit out of our needless suffering.

  5. Ellen says:

    My husband’s neurologist poo-pooed Autonomic Specialists in CA when I inquired about the mesenchymal stem cell therapy they boast about. He said they should be locked up for fraud. I, too, think outside the box and never quick to dismiss something that makes a certain amount of sense. I hope your progress continues. As far as the cost – without insurance to pay for it, it’s a pipe dream to many. Their site quoted about $11k I believe.

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