Stempeutics Nabs US Patent for Osteoarthritis Treatment Combining Bone Marrow Stem Cells and Hyaluronic Acid
The Indian biotech company previously published a Phase 3 RCT comparing its therapy to placebo in 146 KOA patients.
Key Points
- Stempeutics Research received a US patent covering Stempeucel-OA followed by hyaluronic acid for osteoarthritis.
- The treatment uses a single intra-articular dose of 25 million bone marrow-derived mesenchymal stromal cells under ultrasound guidance.
- Stempeutics reported statistically significant improvements in WOMAC scores versus placebo in a 146-patient Phase 3 knee osteoarthritis study.
Stempeutics Research, an Indian cell-therapy developer, announced that the United States Patent and Trademark Office has granted US patent No. 12,661,377 for its treatment approach using Stempeucel-OA for osteoarthritis.
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The patent covers an ultrasound-guided, intra-articular treatment involving a single dose of Stempeucel-OA administered before a single injection of mid-molecular-weight hyaluronic acid. Stempeucel-OA contains 25 million ex vivo expanded, pooled and cultured adult human bone marrow-derived mesenchymal stromal cells.
The therapy is intended to reduce inflammation and pain, improve joint function and support preservation of cartilage quality in patients with Grade II and III knee osteoarthritis. The patented invention also covers methods associated with increasing levels of anti-inflammatory markers and decreasing levels of disease-progression markers in individuals with osteoarthritis.
Stempeutics cited an estimated 48.4 million people in India living with knee osteoarthritis in 2021. In India, the therapy is marketed as CiploStem by Cipla and StemOne by Alkem Laboratories.
Phase 3 findings
The patent builds on the clinical development of Stempeucel-OA for knee osteoarthritis, including a Phase 3 study involving 146 patients. Stempeutics reported a statistically significant improvement of 71.43% compared with placebo on the primary endpoint, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) composite index (p<0.0001).
The company also reported statistically significant improvements in the secondary endpoints of WOMAC pain, stiffness and physical function. It said MRI T2 mapping showed maintenance of cartilage quality. Improvements were also observed in high-sensitivity C-reactive protein, the anti-inflammatory marker interleukin-10 and the urinary cartilage degradation marker CTX II in the Stempeucel-OA arm.
Licensing plans
Stempeutics said it has filed more than 100 patents and received more than 60 patent grants globally, including in the US, Japan and the EU.
The company has licensed its technology/product for chronic limb-threatening ischemia in Japan and plans to pursue similar licensing opportunities for osteoarthritis in Japan and globally.
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