When journalists and health researchers write about patients seeking access to unproven stem cell interventions, they typically examine international travel to clinics located in China, India, Mexico, and elsewhere. In contrast, most domestic companies marketing unlicensed and untested stem cell procedures attract less scrutiny. This oversight is perplexing because numerous U.S. clinics advertise stem cell interventions for amyotrophic lateral sclerosis, multiple sclerosis, dementia, and other diseases. Such businesses promote and provide stem cell-based biologics that are not backed by credible safety and efficacy data and have not been reviewed and approved by the FDA. Precision StemCell, based in Gulf Shores, Alabama, is one example of a domestic clinic marketing stem cell interventions that appear to violate federal regulations.
Dr. Jason Williams, a radiologist, established Precision StemCell in 2012. Williams began by marketing adult stem cell procedures for orthopedic problems and sports-related injuries. One of his earliest clients was Rolando McClain, currently a linebacker for the Baltimore Ravens. Shortly after McClain’s procedure, Marquis Maze, then a wide receiver and kick returner for the University of Alabama, received autologous stem cells for a hamstring injury he suffered during the 2012 BCS Championship game. Their visits generated favorable news media coverage of Dr. Williams’ stem cell interventions.
Dr. Williams soon began administering adipose-derived autologous stem cells to individuals with amyotrophic lateral sclerosis and other diseases. To date, Dr. Williams has injected adult stem cells into at least eighteen people with ALS. Dr. Williams has also injected autologous stem cells into individuals with spinal cord injuries, a patient with Alzheimer’s disease, and a child with optic nerve hypoplasia. These procedures cost $15,000 or more per person.
On December 13, 2012, concerned about the safety of the increasing number of individuals with ALS receiving adipose-derived stem cells at Precision StemCell, I contacted the FDA’s Center for Biologics Evaluation and Research and urged FDA officials to investigate the clinic. I took that step because it appeared to me that Dr. Williams was violating federal regulations, putting stem cell recipients at risk of harm, and charging for interventions that had not first been tested for safety and therapeutic efficacy. Dr. Williams’ administration of stem cells to a minor also played a role in my decision to send a letter to the FDA.
Dr. Williams’ stem cell procedures use liposuction to extract fat tissue from patients’ abdomens. Williams next uses collagenase, an enzyme, to break down the adipose tissue and prepare something called a stromal vascular fraction. Stromal vascular fractions contain a mixture of cell types; it is unclear exactly what cells Dr. Williams administers to his patients. Given that Dr. Williams does not appear to test for cell type, dosing level, and viability of cells, it is doubtful that he knows exactly what he injects into patients’ spines and limbs.
Whatever it is that Dr. Williams administers to patients, it is highly unlikely that it provides any therapeutic benefit. Although Dr. Williams tells patients that he uses a medication, Seligilene, to “reprogram” adipose-derived stem cells and convert them into neural stem cells, he has not conducted pre-clinical research to support this claim. Rather, he refers patients to a study other individuals conducted using rats. While he has posted to YouTube a promotional video about his stem cell “research”, Dr. Williams has never publicly disclosed a detailed scientific justification or research protocol for his stem cell interventions and he has never published study results. It also appears that he failed to conduct in vitro research and pre-clinical studies using animal models before he began charging patients for his stem cell interventions.
At present, administration of adipose-derived stem cells to individuals with ALS, Alzheimer’s disease, optic nerve hypoplasia, and other diseases constitutes human experimentation. It is not part of the routine, established practice of medicine. The experimental, unproven nature of such interventions is one reason why they are not covered by insurance plans as evidence-based treatments. The stem cells Dr. Williams injects into patients should be administered within carefully designed clinical studies allowed to proceed only after rigorous scientific and ethical review by the FDA and an institutional review board.
There are at least three reasons why the stem cell interventions Dr. Williams markets and provides should be administered only after submitting an investigational new drug application to the FDA.
First, the medical devices Dr. Williams uses to process stem cells are not approved by the FDA as a point-of-care stem cell processing system. One of the devices he uses is a liposuction kit. The second piece of equipment is a specimen container. Neither device is approved for the intended purpose of processing autologous stem cells.
Second, it appears that Dr. Williams’ stem cell procedures exceed what is known as the “minimal manipulation” standard. Dr. Williams uses collagenase to dissolve adipose tissue and prepare a stromal vascular fraction, he adds platelet rich plasma to the mix, and Seligelene, a drug that is not approved for the intended use of treating individuals with ALS, Alzheimer’s disease, or spinal cord injuries, is used for the ostensible purpose of “reprogramming” adipose-derived stem cells and turning them into neural stem cells.
Third, Dr. Williams takes stem cells from fat tissue and injects them into individuals with ALS, Alzheimer’s disease, and spinal cord injuries. This practice appears to constitute nonhomologous administration of autologous stem cells. What “nonhomologous use” means is that stem cells from fat are being asked to serve a function that they do not ordinarily perform. Stem cells from fat tissue are also injected into parts of the body where they are not normally found. One reason to conduct pre-clinical studies followed by carefully designed, scientific and ethical human subjects research when engaging in such activity is to establish whether administering adipose-derived stem cells in this manner is safe and efficacious.
If Dr. Williams wants to conduct research addressing safety and efficacy of adipose-derived stem cell injections for ALS he should have first submitted an Investigational New Drug application to the FDA and then waited until the FDA let the proposed study proceed or imposed a clinical hold. Instead, it appears that Dr. Williams began injecting adult stem cells into individuals without first submitting an IND application to the FDA or seeking to have a research protocol approved by an IRB. For over a year Dr. Williams has engaged in unapproved, unauthorized human subjects research. Over twenty individuals paid substantial amounts of money to Dr. Williams for these unproven, experimental stem cell interventions.
Dr. Williams failed to conduct pre-clinical studies before marketing his stem cell interventions, failed to submit his research protocol for review by an IRB and the FDA, put ill and injured patients at risk of harm with no realistic prospect of therapeutic benefit, violated federal regulations governing human subjects research and the administration of stem cells, and charged patients for stem cell interventions with identifiable risks and little or no chance of benefit. Such activity merits the scrutiny of both the FDA and Alabama’s Board of Medical Examiners. Administration of such stem cell interventions also exposes Dr. Williams to the possibility that some of his former patients will file lawsuits against him. Litigation against U.S.-based companies that marketed and provided access to unlicensed stem cell interventions is in progress in California and Nevada.
In February 2013, Dr. Peiman Hematti and Stephen Byer, two representatives from ALS Worldwide, visited Precision StemCell. They subsequently posted to the Internet a detailed report that is sharply critical of Dr. William’s stem cell procedures. It appears that their visit has prompted Dr. Williams to announce that in future he will administer adult stem cells to patients in Bogota, Colombia rather than at his clinic in Gulf Shores, Alabama. However, Dr. Hematti and Mr. Byer are patient advocates rather than representatives of an authorized regulatory body capable of enforcing compliance with relevant federal and state regulations. At any time Dr. Williams might decide to resume administering adult stem cells to patients at his U.S. clinic. Also of great concern, Dr. Williams is threatening Dr. Hematti and Mr. Byer with legal action if they do not remove their report from the Internet.
Threats intimating the possibility of litigation are common when stem cell clinics are accused of profiting from interventions that appear to violate federal regulations and put patients at risks. Critics are forced to decide whether to withdraw their concerns or face the threat of a lawsuit and the substantial expenses that typically accompany litigation. Sometimes, depending upon whether the concerns of critics are substantiated, the threat of litigation diminishes following site inspections by duly authorized regulatory bodies. I hope investigators from the FDA and Alabama’s Board of Medical Examiners visit Precision StemCell, meet with Dr. Williams, conduct thorough inspections of his “stem cell processing system” and the facility in which he prepared stem cells for injection, and address whether his stem cell interventions were in compliance with federal and state regulations. While it appears that Dr. Williams now plans to administer adult stem cells at his clinic in Colombia, his activities injecting adult stem cells into patients at his Gulf Shores clinic merit careful scrutiny. Dr. Williams’ latest plan to administer stem cells and “gene therapy” to patients from the United States and elsewhere at a new Precision StemCell clinic in Colombia should also be investigated by federal and state investigators responsible for ensuring compliance with regulations governing the marketing and administration of unlicensed and unproven stem cell interventions.