Rocky Mountain Brain & Spine Institute has previously published blogs on stem cell therapies for back symptoms. If you haven’t read those blogs, here’s the quick “Cliff’s Notes”… stem cells don’t work.
However we have always given the caveat that “if” stem cells were ever to work, then it would be a great treatment option for many patients and revolutionize spine surgery. Well… we may be closer to that day. A company, DiscGenics, recently announced that the US Food and Drug Administration has granted fast track designation for its investigation cell therapy (IDCT).
Interestingly, DiscGenics, may have been the brainchild of the controversial neurosurgeon, Christopher Duntsch, who is currently serving a life sentence in prison, and better known as “Dr. Death”. Duntsch completed an MD-PhD (MD’s are the one’s that help people, Ph.D.’s are the ones that sit in the lab) program, and at least according to the Wondery podcast, one of Duntsch’s original goals may not have been to practice clinical neurosurgery, but be a researcher and entrepreneur. Regardless, Duntsch seemingly was removed from the company years ago, while DiscGenics has continued to research stem cells as a treatment for low back pain and degenerative disc disease.
The DiscGenics investigational cell therapy uses adult allogeinic (human but from a matched donor) progenitor cells (cells in a very early stage of development) from intervertebral disc tissue. In preclinical studies, these cells may be able to repair a degenerated disc. They claim that in mice, rabbits, and dogs their Discogenic Cells:
- Are safe and non-tumor forming
- Have the ability to generate intervertebral-like tissue
- Result in disc height improvement and normalization of tissue architecture
DiscGenics is now conducting two prospective, randomized, double-blinded, sham-controlled multicenter clinical trials in the United States and Japan. This type of trial is the best it gets in regards to proving or disproving an idea and rarely is achievable in a medical study. DiscGenics will, first and foremost, see if their cells are safe and reduce pain. As we’ve discussed in prior blogs, a placebo-effect may have provided pain improvement in other, less well designed, studies with stem cells. The proposed design of this DiscGenics study should overcome a placebo-effect. The secondary outcome, which we all should be most interested in, will be a radiographic improvement. Can their stem cells truly “fix” a degenerated disc.
Both studies are currently enrolling. On August 7, 2019, the first patients were treated in Japan. The patients will be studied over a 12-month period. The US arm is underway in 14 centers across 12 US states and will enroll 60 subjects.
The target end date is August 2021. Results likely will not be released for years.
For more information or to follow the trial click here.
Of note, Wondery (previously presented “Dr. Death”) has also recently released a new podcast, called “Bad Batch”, which investigates a stem cell company who may have sold a product that not only was contaminated with bacteria and caused serious infections, but may not have even contained stem cells at all. The podcast, albeit superficially, explores problems with the stem cell hype in America, potential misrepresentations of unproven benefit from stem cell therapy, and the lack of FDA approval. The company mentioned in this podcast is not DiscGenics. And again, the noteworthy feature of this DiscGenics study is that they may be the first FDA approved company.