Achieving Regeneration in Lumbar Degenerative Disc Disease

DiscGenics’ IDCT (rebonuputemcel), an allogeneic discogenic progenitor cell therapy, recently demonstrated safety and yielded durable improvements in low back pain, function, quality of life, and pain medication usage by 12 weeks in patients with lumbar degenerative disc disease (DDD). These results were seen in 2-year data from the phase 1/2 DGX-A01 study (NCT03347708). The FDA also recently granted IDCT regenerative medicine advanced therapy designation.

CGTLive^™ spoke with investigator Matthew Gornet, MD, spine surgeon at The Orthopedic Center of St. Louis, to learn more about the current unmet needs in the lumbar DDD population and the potential of IDCT to address them. He stressed that the cell therapy could offer both cost-savings and clinical benefit advantages in treating the disease.

CGTLive: What are the current unmet needs with lumbar degenerative disc disease?

Matthew Gornet, MD: For practitioners who treat patients with low back pain, the biggest unmet need right now is there really isn't anything other than surgery to address low back pain, if it fails conservative measures. So, if you have an episode of acute low back pain that goes beyond the standard treatment, we would all advocate the patients get some form of conservative care, like therapy or chiropractic care, and worst case, injections. But if that fails, now the patient has a need for further treatment, what are the possibilities for them? Right now, the only possibilities are either a diskectomy or lumbar spinal fusion procedure, which either don’t yield great results or are very invasive and costly.

So, right now we have a gap in treatment, which is essentially failing conservative care and having nothing else other than invasive, costly surgery. I believe that the new cellular-based treatment from DiscGenicssits right in between those 2 areas. Not only from a cost stand point, but the clinical outcomes, which, at least initially in our trial, showed very favorable outcomes in the high-dose group compared to these alternative treatments, such as fusion or even disc replacement. Now, again, we didn't look at those head-to-head, but we used historical data as a benchmark. So right now, I think there's a lot of promisein these new cellular therapies for patients, as most patients are afraid of surgery, and this gives them options they've never had.

What data have you seen so far with IDCT?

Gornet: It's a prospective, randomized, double-blind clinical trial; this is the first prospective randomized, double-blind clinical trial that I have ever participated in as a spinal specialist. Highlights of the study showed that in the high dose group in appropriately selected patients, we achieved a 15-point improvement or more in a statistically significant group of patients compared to the placebo or the vehicle. This is an early teaser, we'd obviously like more data, but this is an early glimpse of what the possibilities are. The results of this patient group are so favorable, again, compared to the alternatives, that it even adds more excitement.

How could cell therapy change the treatment landscape of lumbar DDD?

Gornet: We were also able to demonstrate an improvement in disk volume. And I can tell you, as a spinal surgeon, I've seen many, many things. I've operated and done many clinical trials, and I've had a lot of publications, but in my experience, in my lifetime, in my career, I have never seen anything, regrow a disc, or make it bigger. But I’ve seen it with IDCT. And we were able to show that in our data. So, the high dose group showing dramatic improvement, visibly and from a mathematical computation, showing that disk volume increased—all those are signs that we're actually regenerating the spine. That right there should excite everyone.

Once we clearly show we can identify and treat structural back pain, that opens the door for other potential treatments if this treatment should fail. If anything, this could refine treating more appropriate patients with spinal surgery, and the other patients who may want to avoid it or be less appropriate for it could use IDCT.

REFERENCES
1. DiscGenics announces positive two-year clinical data from study of discogenic progenitor cell therapy for degenerative disc disease. News release. DiscGenics. January 23, 2023. https://www.prnewswire.com/news-releases/discgenics-announces-positive-two-year-clinical-data-from-study-of-discogenic-progenitor-cell-therapy-for-degenerative-disc-disease-301728259.html
2. DiscGenics announces FDA regenerative medicine advanced therapy (RMAT) designation granted to IDCT for degenerative disc disease. News release. DiscGenics. January 26, 2023. https://www.discgenics.com/news-posts/2023/1/26/discgenics-announces-fda-regenerative-medicine-advanced-therapy-rmat-designation-granted-to-idct-for-degenerative-disc-disease