Autologous adipose tissue derived stem and regenerative cells, as used in this disc injury model, were effective in promoting disc regeneration, as evidenced by disc matrix production and overall disc morphology.
The neuro-interventional patients under study show a lower hemorrhage risk than the population studied by Crawford. A significant superiority with respect to hemorrhage risk is established two years after the start of the PTET treatment.
Study Design:
Systematic review.
Objective:
To review, critically appraise, and synthesize evidence on use of cell
therapy for intervertebral disc repair.
Methods:
A systematic search of PubMed/MEDLINE was conducted for literature published
through October 31, 2018 and EMBASE and
ClinicalTrials.gov
databases through April 13, 2018 comparing allogenic or autologous cell
therapy for intervertebral disc (IVD) repair in the lumbar or cervical
spine. In the absence of comparative studies, case series of ≥10 patients
were considered.
Results:
From 1039 potentially relevant citations, 8 studies across 10 publications on
IVD cell therapies in the lumbar spine met the inclusion criteria. All
studies were small and primarily case series. For allogenic cell sources, no
difference in function or pain between mesenchymal cell treatment and sham
were reported in 1 small randomized controlled trial; 1 small case series
reported improved function and pain relative to baseline but it was unclear
if the change was clinically significant. Similarly for autologous cell
sources, limited data across case series suggest pain and function may be
improved relative to baseline; whether the changes were clinically
significant was not clear. Safety data was sparse and poorly reported. The
need for subsequent surgery was reported in 3 case-series studies ranging
from 6% to 80%.
Conclusions:
The overall strength of evidence for efficacy and safety of cell therapy for
lumbar IVD repair was very low primarily due to substantial risk of bias,
small sample sizes and lack of a comparator intervention. Methodologically
sound studies comparing cell therapies to other treatments are needed.
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