India | January 20, 2026: Stempeutics, a leader in allogeneic cellular medicines for inflammatory diseases, announced the publication of 24-month efficacy and safety results from its Phase 3, randomized, double-blind, placebo-controlled clinical study of Stempeucel-OA® in knee osteoarthritis. The results were published in Osteoarthritis and Cartilage Open, a peer-reviewed international journal.

At 24 months, a single intra-articular injection of Stempeucel-OA® demonstrated statistically significant and durable improvements in clinical outcomes compared with placebo, supporting the therapy’s potential as a disease-modifying treatment for knee osteoarthritis.

Key 24-Month Findings

• Pain and function: Statistically significant improvement in the WOMAC composite index and all WOMAC sub-scores in the Stempeucel-OA® group versus placebo (p < 0.0001).

• Cartilage preservation: T2 mapping showed no worsening of cartilage in the medial femorotibial compartment in the Stempeucel-OA® group, while the placebo group demonstrated progressive degeneration (p < 0.0001). Cartilage volume increased in the Stempeucel-OA® group over time.

• Biomarker response: Urinary C-terminal cross-linked telopeptide of type II collagen (uCTX-II), a biomarker of cartilage degradation, decreased significantly in the Stempeucel-OA® group and increased in the placebo group at Days 90 and 730 (p < 0.0001).

Twelve-month results from the same Phase 3 study were previously published in the American Journal of Sports Medicine (2023;51(9):2254-2266).

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®, and is accessible across major hospitals nationwide.

Dr. Joe Joseph Cherian, MS, Professor and Head of the Department of Orthopaedics at St. John’s Medical College Hospital, Bangalore, and a Phase 3 investigator, commented:

“The two-year follow-up data underscore the potential of allogeneic cellular therapy to address key unmet needs in knee osteoarthritis, particularly in younger patients where existing treatments provide only transient symptom relief without altering disease progression. Based on the Phase 3 data, Stempeucel-OA® demonstrates durable pain reduction, improvements in physical function and quality of life, and the potential to preserve cartilage and slow disease progression in patients with Grade 2 and Grade 3 osteoarthritis as defined by Kellgren–Lawrence criteria.”

Dr. Nikhil Verma, MD, Rush University Medical Center, Chicago, added:

“These results may usher in new directions for the field of cell-based regenerative therapies over the coming decade.” Stempeutics has further characterized the potency of Stempeucel-OA® through its ability to secrete pro-chondrogenic factors, including thrombospondin-2 (TSP-2). TSP-2 is an extracellular matrix protein that plays a critical role in chondrogenic differentiation and in stimulating endogenous chondroprogenitor cells. Given that osteoarthritis is fundamentally driven by progressive cartilage loss, the presence of these factors in the MSC secretome provides a plausible mechanistic link to the observed clinical and structural outcomes.

Dr. Pawan Gupta, President, Medical & Regulatory Affairs at Stempeutics, stated:

“Osteoarthritis is one of the most prevalent and debilitating conditions associated with aging, with increasing incidence driven in part by rising obesity rates. In India alone, an estimated 30 million individuals are affected. Current treatment options largely focus on temporary pain relief and inflammation control without altering disease progression. Stempeucel-OA® has the potential to deliver durable symptom improvement while preserving cartilage and slowing disease progression in patients with radiographic Grade 2 and Grade 3 osteoarthritis.”