There’s some also encouraging action at the state level on direct-to-consumer stem cell clinics operating without FDA approval including most recently in Washington State.
Last year here in California we passed a bill into law that (1) requires stem cell clinics selling non-FDA approved therapies to post notices for patients and (2) instructs the state medical board to keep track of the situation. Democratic Senator and Dr. Ed Hernandez was the sponsor.
More recently Republican lawmakers in the Florida State legislature sponsored a bill aiming to go much further with clinic oversight. Now Washington State has a pending bill (H.B. 2356) sponsored by Democratic Rep. Eileen Cody that would follow California’s lead in requiring clinic notices to patients.
You can learn more about the Washington bill in this opinion piece by two leaders in the stem cell research field up in the Seattle area, Drs. Chuck Murry and C. Anthony Blau of the University of Washington (UW). I was up visiting the UW just a few months ago to give a talk at their Institute for Stem Cell and Regenerative Medicine. It was great to visit there and learned a lot about the stem cell research ongoing at the UW including from Dr. Murry.
Topic of the Seattle area for-profit stem cell clinics also came up during the visit. The main newspaper up there, The Seattle Times, has run several ads for stem cell clinics selling unproven therapies that lack FDA approval just as we’ve seen happening across the U.S. with mainstream media ad buys these days including here in Sacramento.
I hope more common sense state laws get passed that then as laws provide consumer protections and protect patients. The Washington State bill seems right on track toward that goal. We’ll see if it and the Florida bill end up passing.
My interest in this type of procedure is that I have chronic GVHD & slowly progressing scleroderma as a result of the allogeneic peripheral blood stem cell transplant that I received July 2016. It was a 100% match found through Be The Match, but GVHD has been a difficult condition to handle. Although stem cell transplant/BMT has been used over the past 40 years for treating/curing bone marrow cancers the development of methods/drugs to combat GVHD has been very slow. The use of MSCs might be of value to a patient like myself, there have been clinical trials that indicate positive results in MSC application to modulate the donor’s immune system and reduce if not eliminate the use of medications and steroids that have detrimental side effects. Quality of life after transplant is important, GVHD is a serious aliment in transplant patients. SCCA in Seattle has mentioned that this is an important area to develop therapies and they have emphasized the effort to find an answer.
I have done much web based searching on details of this emerging treatment clinic theater. There are two suppliers of umbilical cord and Wharton’s Jelly to some of the clinics I have contacted: Predictive Biotech and Utah Cord Bank. Are their products effective ? Their web site professes highest quality and safety in their product. According to the clinic owners they are effective, your opinion ? Through various YouTube videos, NIH reports, PubMed articles, anecdotal testimony by: Arnold Caplan PhD, Neil Riordan PhD, Timothy Henry Chief of Cardiology, Roberta Shapiro MD, Asher Milgrom PhD, umbilical cord MSCs are effective. It is generally presented that adipose derived MSCs, MSCs autologous MSCs from a human 60+ years, are not effective, the best source for MSCs are umbilical cord, and then tissue cultured out to 4×10^6, 40×10^6, or 3×10^8 numbers used for infusion/injection, are claimed to be effective. The adipose MSCs are unable to be grown out into sufficient numbers to be effective, and the activity is not as vigorous as from umbilical cord. Is this a valid perspective ? Umbilical cord MSCs are “newly minted” and will grow out exponentially, is this true ? The FDA has defined the field source of material to be used, why have they not included umbilical cord, and allowed the tissue culture of this for treatment ? There are clinics offering umbilical cord derived MSCs internationally and in the US. The majority of clinics that I have spoken to over the phone indicated that they use umbilical cord derived MSCs, supplied by the sources mentioned above. A relatively new company Mesoblast Ltd. of Australia has a progenitor MSC product that is approved for market/use in Japan. The company is in talks with the FDA for permission to market it in the US. Please comment on this. My own opinion is that the medical treatment field is on the cusp of a change in treatment protocol using stem cells in general. The need for double blind trials is more relevant to toxicity of defined drugs used for treatment. I have not read one professional article that found toxicity a problem with the administration of clinically approved MSCs for clinical trial. The media is portraying the industry as a whole in a negative light using certain unprofessional clinics that have done harm to the patient as examples of the danger. I’m inclined to think that umbilical cord derived MSCs are the most beneficial method to use. Please tell me your thoughts on this. Thank you for a response.
Neil
True, there are no FDA approved clinics. It is all still investigational, as far as consulting with a reputable clinic, ask around, post on a social site who has had good results and with whom ?
This is a big problem. As far as I know for many therapies nobody is doing a big double-blind study to test its efficacy (maybe there a clinics who don’t have any interest to get this data concerning their own therapies) and because of missing trials and missing big data many therapies will maybe never be approved.
I suffer from knee OA and I was recently looking into the Rejuv clinic in St. Cloud, MN. They claim to have great success with bone marrow stem cells, PRP and Prolotherapy. Any opinion or info ?
How can I distiguish between an unproven and a proven stem cell clinic?
Good question. I’m not sure any are fully proven at this point in the sense of properly controlled data showing safety and efficacy. However, there is a wide range of different clinic practices that are important to keep in mind and evaluate as best as one can. Do they collect and publish data in reputable journals? Do they include control subjects who get placebo? Are their products compliant with FDA regs? For example, I may not yet be convinced that bone marrow cells really help with osteoarthritis, but such a use is often going to be compliant so such a clinic may not be breaking the rules. In contrast, using fat stem cells for almost any non-cosmetic uses is generally these days going to be breaking FDA rules.