Cell Therapy for Treatment of Intervertebral Disc Degeneration: A Systematic Review.
- Meisel HJ, Agarwal N, Hsieh PC, Skelly A, Park JB, Brodke D, Wang JC, Yoon ST, Buser Z
- Global spine journal | 9 (1 Suppl) | May 2019
Cell therapy treatments for disc degeneration remains a very exciting area of research. Currently, there are multiple clinics offering forms of these treatments for patients with lower back pain.
The science data supporting the use of these techniques remains limited.
The Author’s of this paper reviewed Pubmed/MEDLINE data through October 31, 2018, as well as clinical trial data from EMBASE and ClinicalTrials.gov to April 13, 2018 concerning cell therapy for intervertebral disc repair. Case series of greater than 10 patient’s were considered.
As this was a meta-analysis, the authors themselves did not conduct the actual studies. They did compound the information to draw some conclusions.
Each individual study was assessed for bias as well as methodology quality by two reviewers using Cochorane Handbook, JBJS, and AHRQ criteria.
From the original 1039 potential citations, 12 studies were selected for full review. Only 8 studies met inclusion criteria for review. The N numbers were relatively small. There is one randomized clinical trial. There is one study reporting from the phase 1 pilot randomized clinical trial. There was 5 case series. There was one single arm registry study. The largest N number was 33 patients. All the studies were based on the lumbar spine.
Review of the aggregated population indicates a mean age of approximate 40. Patients were predominantly male. Not all of the studies used autologous cell sources.
3 of 5 series reported improvement of function based on ODI scores compared with baseline at 3, 6, and 12 months.
Safety evidence was poorly reported in the studies.
Study designs did not evaluate the Modification of treatment effects.
There was no economic impact or cost data.
The authors concluded cell therapy for lumbar intervertebral disc repair Strength of evidence for both efficacy and safety was very low on the studies.
The authors expressed concerns about the relative small sample sizes. There is potential for underreporting adverse events from these techniques. Because of the heterogeneity of the populations, and lack of reporting I have treatment effects, the authors also express concerns about any efficacy data from the studies.
The authors did acknowledge some conflict of interest in relationship to the research and other ship and publication.
As in all basic science clinical research, the gold standard would be A randomized clinical trial, with matched Study populations, with adequate numbers to power meaningful data analysis. Unfortunately, we do not have that type of information at this time.
We commend the authors for their professionalism, as they explore a therapeutic option that has multifaceted ramifications.
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