Stempeutics mesenchymal stem cell therapy is approved in India for treating critical limb ischemia due to multiple causes.
Stempeucel allogeneic mesenchymal stem cell (MSC) therapy (Stempeutics) improved symptoms of grade 2/3 osteoarthritis, according to new findings from a phase 3 trial conducted in India published in The American Journal of Sports Medicine.
“Mesenchymal stromal cells (MSCs), which have the potential for cartilage regeneration in osteoarthritis, have been presented as an alternative source for cell-based therapy to chondrocytes.The regenerative potential of MSCs is of interest in osteoarthritis, as very few treatment modalities have been shown to reverse or stop the loss of cartilage,” first author Pawan Kumar Gupta, MD, DNB, PhD, and coauthors wrote in the paper.
Gupta and colleagues investigated stempeucel in 146 patients with grade 2/3 osteoarthritis randomized to either a single intraarticular injection of 25 million cells of bone marrow-derivedMSC(BMMSC) treatment or placebo in a 1:1 ratio, followed by 20 mg/2 mL hyaluronic acid under ultrasound guidance. Stempeucel is approved in India for treating critical limb ischemia (CLI) due to Buerger’s Disease and CLI due to atherosclerotic peripheral arterial disease. In addition to osteoarthritis, Stempeutics is developing the therapy for indications of diabetic foot ulcer, perianal fistula and acute respiratory distress syndrome due to COVID-19 pneumonia.
The trial’s primary end point was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score and secondary end points were WOMAC subscores for pain, stiffness, and physical function; the visual analog scale score for pain; and magnetic resonance imaging findings using T2 mapping and cartilage volume. The study is registered under the identifier CTRI/2018/09/015785 in the National Institutes of Health and Clinical Trials Registry in India.
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“Osteoarthritis is a chronic, progressive, and degenerative condition with limited therapy options. Recently, biologic therapies have been an evolving option for the management of osteoarthritis,” the authors wrote.
Overall, the investigators evaluated data from 65 patients treated with Stempeucel and 68 treated with placebo that had completed 12-month follow-up. Both groups of patients had similar baseline characteristics, including high visual analog scale (VAS) and WOMAC scores. The treated group showed significant improvements in the WOMAC total score compared with the placebo group at 6 (-23.64% [95% CI, -32.88 to -14.40]) and 12 months (-45.60% [95% CI, -55.97 to -35.23]; P <.001 for both time points).
“In this small, randomized trial, BMMSCs proved to be safe and effective for the treatment of grade 2 and 3 osteoarthritis. The intervention was simple and easy to administer, provided sustained relief of pain and stiffness, improved physical function, and prevented worsening of cartilage quality for up to 12 months,” Gupta and coauthors wrote.
BMMSC-treated patients also experienced significantly improved on WOMAC pain, stiffness, and physical function subscores, as well as VAS scores at 6 and 12 months (P <.001). Investigators foundno worsening of deep cartilage in the medial femorotibial compartment of the knee in the BMMSC group at 12-month follow-up according to T2 mapping compared with significant and gradual worsening of cartilage in the placebo group (P <.001). Cartilage volume did not change significantly in theBMMSC group.
There were 5 adverse events [AEs] in 4 patients (5.5%) of swelling and pain at the injection site that were possibly/probably related to stempeucel and improved within a few days. One treatment-emergent AE of COVID-19 was fatal. Other serious AEs included, in 4 patients in the stempeucel group, intestinal obstruction (n = 2), COVID-19 (n = 2), gastroenteritis (n = 1), and severe fever with thrombocytopenia. Serious AEs in 4 patients in the placebo group included COVID-19 (n = 2), transient ischemic attack (n = 1), and hypertension (n = 1). These serious AEs were deemed unrelated to study treatments.
“For future studies, it may be interesting to observe the safety and efficacy of genetically modified MSCs overexpressing IL-10 and transforming growth factor–beta in osteoarthritis,” the investigators concluded.
