Allogeneic disc progenitor cells may improve outcomes for patients with disc degeneration
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Key takeaways:
- High-dose injectable disc cell therapy may yield improved outcomes for patients with degenerative disc disease.
- High-dose allogeneic disc progenitor cells decreased pain scores up to 2 years.
High-dose allogeneic disc progenitor cells may provide a regenerative solution for lumbar degenerative disc disease, as patients demonstrated clinical improvements for pain and disc volume up to 2 years, according to published results.
Mathew F. Gornet, MD, a spine surgeon at The Orthopedic Center of St. Louis, and colleagues randomly assigned 60 patients (mean age, 37.9 years) with symptomatic single-level lumbar degenerative disc disease to receive a single intradiscal injection of low-dose progenitor cells (3,000,000 cells/mL; n = 20), high-dose progenitor cells (9,000,000 cells/mL; n = 20), the vehicle alone (sodium hyaluronate; n = 10) or placebo (normal saline; n = 10).
Outcomes were assessed from baseline to 2-year follow-up and included VAS pain scores, disc volume on radiographs and adverse events. Overall, patient follow-up was 85% at 2 years.
Patients who received high-dose progenitor cells had a mean percentage decrease in VAS pain scores of –62.8% at 1 year. Gornet and colleagues noted this decrease was significantly greater than the minimal clinically important difference of 20 points and was maintained at 2-year follow-up. They also noted patients who received high-dose progenitor cells were the only patients who had a significant change in disc volume, with mean increases of 249 mm3 at 1 year and 402.1 mm3 at 2 years.
Gornet and colleagues found patients who received the vehicle alone also had a significant mean percentage decrease in VAS pain scores of –52.8% at 1 year. They noted patients who received low-dose progenitor cells and patients who received the placebo had no significant improvements in VAS pain scores at 1 year.
Overall, researchers found 6.7% of patients experienced a serious adverse event. However, no patients who received progenitor cells had a serious adverse event.
“The promising results of high-dose [injectable disc cell therapy] IDCT in this study, particularly the sustained decrease in low back pain and improvements in function, quality of life and disc volume, support further development of this therapy,” Gornet and colleagues wrote in the study.
Perspective
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Cell and gene therapy for symptomatic degenerative disc disease addresses the pathophysiologic processes of the condition through immunoregulatory activities that is related to pain reduction and downstream matrix protection. Disc progenitor cells has been the first cell source studied in human trials, and the current report further shows safety and trend of efficacy. Mesenchymal stem cells are a most studied source for cell therapy based on the same hypothesis of immunoregulatory and potential trophic effect, for which safety has been well established. The outcome of cell therapy, regardless of cell sources, has been promising showing trend but no breakthrough has been evident. Future research will focus on genetic modification of various types of cells and extracellular vesicles, including induced pluripotent stem cells and cell products, that will focus on augmented efficacy through over-expressed targeted molecules and improved patient access through scalability in manufacturing and lowered cost.
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