The following should not be taken as a recommendation (or warning) regarding Precision Stem Cell. However, that facility was recently rendered an injustice which requires correction.
On March 19, 2013, ALS Worldwide (ALSWW) published a report on the procedure carried out by Dr. Jason Williams at Precision Stem Cell in Gulf Shores, Alabama (PSC). The report was particularly scathing. However, it was replete with inaccuracies. I would like to contrast points from the ALSWW report with facts reported to me from a number of independent sources which include Dr. Williams, persons who have visited his clinic, and patients treated by Dr. Williams in the subject stem cell procedure. To begin with, I will briefly explain the theoretical underpinnings of the procedure Dr. Williams performed, as well as his motivation for doing something outside of his original medical training.
Dr. Williams explains his history, procedure, rationale, and plans for development in a recently-released video. He had been doing mesenchymal stem cell (MSC) extraction and delivery into joints for a time, a somewhat routine procedure done in many clinics as a sports rehabilitation therapy. A friend, Frank Orgel, approached him about trying the procedure to treat his own ALS. Dr. Williams was initially skeptical but after online literature research learned of studies done using this technique in laboratory settings. Note that the link here is not necessarily the one used by Dr. Williams. The reader can search PubMed using the terms “autologous stem cells amyotrophic mesenchymal” and be presented with results which are representative of the applicable published studies.
Selegiline (Anipryl, L-deprenyl, Eldepryl, Emsam, Zelapar) is a drug used for the treatment of early-stage Parkinson’s disease, depression and senile dementia. Dr. Williams found published studies suggesting that selegiline treatment of MSCs was sufficient to trans-differentiate them toward a neural lineage. Dr. Williams extracts the MSCs via machines made exactly for the purpose of extraction of adipose (fat) tissue and real-time separation of MSCs from the adipose tissue. The extraction and separation process is all done in a sterile closed system. The MSCs are then bathed in selegiline solution created by from powder mixed with sterile saline using a professional compounding protocol. After treatment, the cells are then injected into the spine via lumbar puncture The idea is that the treated cells are a mixture of MSCs and neural-lineage cells which then quell the inflammatory aspect of ALS and provide neurotrophic factors. The extent and duration of benefit is presumed based on severity of progression (ie patients with a slower, less aggressive, progression would experience more benefit and of a longer duration).
TCA Cellular of Louisiana had been previously conducting a clinical trial using intrathecal delivery of MSCs to treat ALS until they were shut down for improperly administering the procedure outside of trial (including allogenic products delivered to some patients). Currently, The Mayo Clinic is conducting a similar trial. Clearly there is scientific rationale for investigating this procedure as a treatment for ALS. While Dr. Williams started with the cart before the horse, if you will, he has matured his operation into a true investigative research program. He is partnering with accredited researchers and is forming a company specifically to handle the research program. Together they are working on a genetic modification of the MSCs to more abundantly deliver anti-inflammatory and neurotrophic factors as well as concurrent delivery of the treatment vehicle to the patient cells to help the host cells defend themselves from disease process. This can be likened to the Brainstorm product which nearly everyone is excited about.
1. Precision Stem Cell is conducting a trial
As discussed above, Dr. Williams never claimed that his procedure was a clinical trial. He expanded his current practice of treating joint damage to ALS by request of a friend seeking the possibility of relief via MSC injection. Labeling the procedure as a “trial” and then remarking that there is no rigorous data collection is disingenuous at best. Further, discussion of pricing in the report appears deliberately worded to taint Dr. Williams as a con artist of the sort endemic in the world of life-threatening diseases. Dr. Williams is indeed now planning a trial, in preparation for which he has ceased treating patients, but none of the previous treatments were ever represented as a trial. Dr. Williams had been planning to transition to a trial many months prior to the ALSWW visit.
2. Dr. Williams has no credentials as a neurologist/plastic surgeon
This is true. However, neither of these qualifications are necessary to perform the subject procedure. Mechanically it is almost no different from the joint therapy he has been performing for years. Injection into the spine does carry extra risk. However, nurses without neurology credentials routinely administer spinal taps and injection of spinal block anesthesia daily around the United States, and without benefit of the imaging equipment employed by Dr. Williams. Insofar as the liposuction, Dr. Williams is certified in the use of that equipment since 2010 and can produce a copy of such certificate upon demand.
3. Positive effects lasted only 1-4 days
While the positive effects noted by some patients could indeed merely be placebo effect (impossible to determine either way absent double-blind trial), how Mr. Byer makes this claim is a puzzle. He never contacted any of the patients referred to him by Dr. Williams. The “days” time estimate Mr. Byer repeated in the ALSWW report appears to have come from a public post from a person on the ALSTDI forum. That person denies having been contacted by Mr. Byer.
4. The clinic is a poorly-equipped “stem cell facility”
Leaving aside a discussion of exactly what a “stem cell facility” is, PSC is a radiological facility. No surgical procedures are performed. The equipment used to extract, manipulate, and reintroduce the MSCs are all routine equipment useful in many procedures involving filtering and extraction of select fluids/tissue. The protocol for harvesting MSCs has been well-documented for decades. The liposuction and extraction are done with machines built exactly for those tasks in a closed system which guarantees sterility. The mention of the equipment not being FDA-approved for extracting MSCs is a total red herring apparently intended to taint the reader’s opinion of PSC.
5. Sterile procedures are not followed – infection risk
Sterile procedures are indeed not followed. The reason for this is that they are unnecessary. The entire movement of cells is done via hypodermics, transferring from the patient from one sealed sterile container to another throughout the entire process and back to the patient. Alcohol swab wipe on external surfaces prior to injection is all that is necessary. There is no open surgery requiring a sterile environment. Despite the claim in the ALSWW report, surgical drapes are indeed used during liposuction. Talking about the radiology suite as an “OR” is another disingenuous attempt to discredit PSC. The table talked about is a standard flouroscopy table so Dr. Williams can use imaging guidance for his procedure. Photographs reveal the table to be very clean and in fine shape. Since patients are not under general anesthesia or sedation, the risk of “easily falling off” is a function of zero.
6. Patients have retracted statements of benefit
This claim is a mystery because the patients to whom Dr. Williams referred Mr. Byer deny having been contacted. The patient Mr. Byer apparently used in this example denies having been contacted by Mr. Byer. Further, he maintains his original statement.
7. Williams uses a 0.8 micron filter making MSC harvest impossible
Dr. Williams uses an 80 micron filter. It is possible that Mr. Byer was observing another filter type or misread the label. Dr. Williams admits the possibility of having handed Mr. Byer a 0.8 micron filter by accident. Nevertheless, this question could have been resolved by email or phone call prior to publication.
8. The selegiline mixture is unsanitary
The selegiline is not, as claimed in the ALSWW report, ground in a mortar and pestle at PSC. The selegiline solution used for bathing the MSCs is made with sterile saline (not distilled water) under the guidance and protocol of David Rothbardt, a registered compounding pharmacist. According to Dr. Williams, neither Mr. Byer nor his medical adviser Dr. Hematti ever observed compounding of selegiline at PSC. Further, the selegiline is removed via rinse after bathing period and prior to reintroduction to the patient.
9. The PSC facility has no vapor lock system
Perhaps Mr. Byer has confused PSC with a biohazard facility? This allegation makes no sense and appears another in a long string of comments included to confuse the uninformed and unwary.
As demonstrated above, the report by ALSWW is full of inaccuracies, misrepresentations, and diversions from truth. The motivations for Mr. Byer to publish that report are beyond the scope of this blog post. The facts are that PSC is a clinic offering a treatment used by many clinics for joint rehabilitation. The equipment and techniques are common and well-documented. The facility is clean and the procedure is carried out under appropriately-sterile conditions. The applicability of this treatment to ALS is unknown, although the study data available is compelling enough for The Mayo Clinic to run a clinical trial.
There are some questions regarding the treatment provided by Dr. Williams. The dosages administered are estimates based on instrument capacity rather than actual flow cytometry count. The data regarding selegiline needs further independent verification. Without evaluation, it’s impossible to know how complete is the presumed process of trans-differentiation of MSCs to neural lineage. The efficacy of either straight or selegiline-treated MSC intrathecal injection is still an open question.
However, one thing is clear: PSC did not deserve such a baseless derogatory review from ALSWW.