Stempeucel-OA demonstrates durable 24-month efficacy & cartilage preservation in phase 3 knee osteoarthritis Study

New Delhi: Stempeutics, a leader in allogeneic cellular medicines for inflammatory diseases, has announced the publication of 24-month efficacy and safety results from its Phase 3 randomized, double-blind, placebo-controlled clinical study of Stempeucel-OA® for knee osteoarthritis.

The findings were published in Osteoarthritis and Cartilage Open, a peer-reviewed international journal.

At the 24-month follow-up, a single intra-articular injection of Stempeucel-OA® demonstrated statistically significant and durable improvements in clinical outcomes compared with placebo, reinforcing its potential as a disease-modifying therapy for knee osteoarthritis. Patients treated with Stempeucel-OA® showed marked improvements in pain and physical function, as reflected by significant gains across the WOMAC composite index and all WOMAC sub-scores, with strong statistical significance. Imaging assessments using T2 mapping revealed preservation of cartilage in the medial femorotibial compartment in the treatment group, while patients receiving placebo experienced progressive cartilage degeneration.

Notably, cartilage volume increased over time in the Stempeucel-OA® group. Biomarker analysis further supported these findings, with a significant reduction in urinary C-terminal cross-linked telopeptide of type II collagen, a marker of cartilage degradation, in treated patients, in contrast to an increase observed in the placebo group at both early and long-term time points.

Earlier 12-month data from the same Phase 3 study had been published in The American Journal of Sports Medicine in 2023, and the newly reported two-year results extend the evidence for sustained clinical and structural benefits.

In India, Stempeucel-OA® is commercially available through marketing partnerships with Alkem Laboratories under the brand name StemOne® and with Cipla under the brand name CiploStem®. The therapy is accessible across major hospitals nationwide.

Commenting on the findings, Dr. Joe Joseph Cherian, Professor and Head of the Department of Orthopaedics at St. John’s Medical College Hospital, Bangalore, and a Phase 3 investigator, said the two-year follow-up data highlight the potential of allogeneic cellular therapy to address key unmet needs in knee osteoarthritis, particularly among younger patients. He noted that existing treatments often provide only transient symptom relief without altering disease progression, whereas the Phase 3 data for Stempeucel-OA® indicate durable pain reduction, meaningful improvements in physical function and quality of life, and the potential to preserve cartilage and slow disease progression in patients with Kellgren–Lawrence Grade 2 and Grade 3 osteoarthritis.

Dr. Nikhil Verma of Rush University Medical Center, Chicago, said the results could open new directions for cell-based regenerative therapies over the coming decade. He added that Stempeutics has further characterized the potency of Stempeucel-OA® through its secretion of pro-chondrogenic factors such as thrombospondin-2, an extracellular matrix protein known to play a critical role in chondrogenic differentiation and activation of endogenous chondroprogenitor cells. Given that osteoarthritis is driven by progressive cartilage loss, the presence of these factors in the mesenchymal stem cell secretome provides a plausible mechanistic explanation for the observed clinical and structural benefits.

Dr. Pawan Gupta, President of Medical and Regulatory Affairs at Stempeutics, highlighted the growing burden of osteoarthritis, describing it as one of the most prevalent and debilitating conditions associated with aging, with rising incidence partly linked to increasing obesity rates. He noted that an estimated 30 million people in India alone are affected. While current therapies primarily focus on short-term pain relief and inflammation control, he said Stempeucel-OA® has the potential to deliver sustained symptom improvement while preserving cartilage and slowing disease progression in patients with radiographic Grade 2 and Grade 3 osteoarthritis.

The original publication is available at Osteoarthritis and Cartilage Open via ScienceDirect.