Living progenitor cells, often misnamed “Stem Cells,” have been put forward as potential treatments for a wide variety of indications. Unfortunately, in most of those cases, scientifically robust data does not exist.
With regards to COVID-19, however, level one clinical studies conducted by top labs, have found that they may be beneficial for patients suffering from COVID-19 and, when combined with other recent studies, that such living progenitor cell treatments may be closer to broad application status.
Named the “Breakthrough of the Year” by Science in 1999, claims of the uses of stem cells abounded, with promises of cures for Duchenne’s muscular dystrophy (which only this year has seen some success in early trials of gene therapies) to restoring feeling and movement in patients with paralysis from spinal cord injuries. As with most scientific breakthroughs, early understanding usually leads to ambitious timelines and overpromised successes (for example, a cure for cystic fibrosis was promised within a few short years after identifying the gene responsible in 1989. Research toward a cure is still on going, over 30 years later). Only recently are we seeing benefits from stem cell research, and due to the unregulated nature of the treatments, it is difficult to tease out the efficacy.
Before the U.S. FDA clamped down on some stem cell clinics in 2017, the treatments were used, without substantial evidence of safety or efficacy, for just about anything. The FDA took action in 2017 to close down some stem cell clinics offering “cures” for amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), macular degeneration, Parkinson’s disease, and more after three patients who were treated for macular degeneration were left blinded. Hopefully, the FDA will continue to exert pressure on clinics to, at the very least, encourage proper handling of the cells to prevent infection, but to also strive toward using the products for evidence-based therapies.
In orthopedics, several options are currently available to provide cell-based therapies to patients. The primary options include platelet-rich plasma (PRP), and bone marrow aspirate concentrate (BMAC). Both of these treatments involve extracting autologous tissue samples (blood or iliac crest bone marrow), concentration and extraction of cellular components and reinjection to the treatment site. PRP is a relatively inexpensive process, which costs about $700, while a BMAC preparation costs in order of magnitude more. Both treatments are considered investigational and are not covered by insurers, so they are typically reserved for patients with the desire and means to pay out-of-pocket. The first FDA approved cellular therapy for orthopedic use is MACI from Vericel. The therapy requires extraction and shipment of a sample of the patient’s knee cartilage to the company which expands and cultures the cells in a porcine collagen membrane. The final product is then shipped to the surgeon for implantation in a second procedure.
