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February 27, 2023
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High-dose allogeneic disc progenitor cells may improve low back pain

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CHICAGO — Results showed a high-dose injection of allogeneic disc progenitor cells for treatment of degenerative disc disease yielded statistically significant improvements in low back pain, function, quality of life and disc volume.

“Early data shows not only can we decrease patients’ back pain, improve their function as measured by the Oswestry Disability Index, [and] decrease their narcotic usage, but, most important of all, we’re seeing that we can regrow their disc and, intuitively, something that can regrow their disc and improve disc height and volume is a game changer,” Matthew F. Gornet, MD, of the Orthopedic Center of St. Louis in conjunction with Spiritt Research, told Healio about results presented at the North American Spine Society Annual Meeting.

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Improved VAS scores

Gornet and colleagues randomly assigned 60 patients with early to moderate, symptomatic lumbar degenerative disc disease to receive low-dose injectable allogeneic disc progenitor cells and a viscous carrier (n=20), high-dose injectable allogeneic disc progenitor cells and a viscous carrier (n=20), the viscous carrier alone (n=10) or a placebo (n=10). Researchers assessed low back pain VAS, Oswestry Disability Index (ODI) and EuroQol-5D for 52 weeks.

Results showed patients in the high-dose cell group had statistically significantly improved VAS scores vs. baseline at 12, 26 and 52 weeks after injection, while patients in the viscous carrier group achieved statistical significance in VAS at 52 weeks. Although mean pain VAS improved from baseline after treatment, researchers found it only achieved statistical significance at 26 weeks in the low-dose cell group and placebo group.

Gornet noted patients in the high-dose cell group had a statistically significant increase in disc volume compared with the other groups. This increase in disc volume was maintained for 2 years, according to Gornet.

“To have something that will regrow your disc is obviously novel, it’s exciting and it’s disruptive in the sense that it will, I think, completely redo how we initially treat low back pain that is refractory to conservative care,” Gornet said.

Decrease in narcotic usage

Researchers noted patients in the high-dose cell group had reduced back pain VAS from baseline that was statistically significantly greater than a minimum clinically important difference (MCID) of –20 mm at 52 weeks. Patients in the high-dose cell group also experienced an improvement in ODI score from baseline at 52 weeks that was statistically significantly greater than a MCID of –10 points and an EQ-5D index score that was statistically significantly greater than a MCID of 0.08, according to results.

“The improvement we got in Oswestry Disability Index in particular rivaled disc replacement surgery,” Gornet said. “If you look at where we are, disc replacement is probably the gold standard for treatment for single-level symptomatic discogenic pain. Our Oswestry point improvement was close to [disc replacement] beginning at 6 months and then carrying out to 2 years.”

Gornet added that patients in the high-dose cell group experienced a decrease in narcotic usage compared with patients in the other groups.

“So, we’re seeing a dramatic improvement in other health care measures, and we know what opiates do to patients in our general population and where that ultimately leads,” Gornet said. “This, at least for back pain, shows some promising data.”

References:

DiscGenics announces positive 2-year clinical data from study of discogenic progenitor cell therapy for degenerative disc disease. https://www.discgenics.com/news-posts/2023/1/23/discgenics-announces-positive-two-year-clinical-data-from-study-of-discogenic-progenitor-cell-therapy-for-degenerative-disc-disease. Published Jan. 23, 2023. Accessed Feb. 27, 2023.