HealthDay News – Results from a phase I, uncontrolled, dose-escalation study found that a single intra-articular injection of autologous adipose-derived stromal cells (ASCs) can reduce pain and inflammation related to knee osteoarthritis (OA). These results were published in Stem Cells Translational Medicine.
Christian Jorgensen, MD, PhD, head of the clinical unit for osteoarticular diseases at Lapeyronie University Hospital in Montpellier, France, and colleagues focused on 18 French and German men and women, aged 50 to 75, with severe knee OA for at least a year before joining the study.
High Yield Data Summary
- Intra-articular injection of autologously-derived ASCs may be a safe therapeutic option for severe knee OA
Between April 2012 and December 2013, all of the patients first underwent liposuction to extract fat-derived samples of specific stem cells. One-third of the patients received a single, low-dose injection of autologous ASCs directly into their knee. Another third received a medium-dose injection, and the remaining group received a high-dose injection.
After six months, the study team found that all three groups showed improvements in terms of pain, function, and mobility. However, only those in the low-dose group were determined to have statistically significant improvements in terms of both knee pain and function recovery.
Apart from one case of chest pain (about three months after the injection), only a few patients experienced mild side effects.
Summary and Clinical Applicability
Data from this phase I study provided preliminary evidence for ASC efficacy in knee OA in a a limited number of patients.
“The potential mode of action of ASCs for the treatment of OA includes… direct differentiation of ASCs into chondrocytes.. [and]possible paracrine effect of secreted bioactive molecules, including anti-inflammatory and chondroprotective mediators,” the authors concluded.
Limitations and Disclosures
A placebo arm was not included in this uncontrolled trial. Clarification of lack of dose-response curve will have to be elucidated.
Pers Y, Rackwitz L, Ferreira R et al. Adipose mesenchymal stromal cell-based therapy for severe osteoarthritis of the knee: A Phase I dose-escalation trial. Stem Cells Transl Med. 2016. doi:10.5966/sctm.2015-0245.