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Stempeucel - Cell Therapy to treat Critical Limb Ischemia (CLI)
Stempeucel® is our flagship product. It is an on-demand, off-the-shelf product based on pooled, allogeneic Mesenchymal Stromal Cells (MSC) derived from bone marrow of healthy, adult volunteers. In August 2020, Drug Controller General of India (DCGI) has granted manufacturing and marketing approval of Stempeucel® product for the treatment of CLI due to Buerger’s Disease and CLI due to Atherosclerotic Peripheral Arterial Disease. Stempeucel® becomes the first allogeneic cell therapy product to be approved for commercial use in India and the first stem cell product to be approved Globally for CLI indication. Stempeucel® is being developed for the treatment of Knee Osteoarthritis (OA), Diabetic Foot Ulcer (DFU), Perianal Fistula (PAF) and Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 pneumonia.
Cell Bank Generation
The patented production process includes an unique process of multiple cell bank generation from which the Investigational Medicinal Product (IMP) is produced.
Robust Cell Yield
The addition of growth factors to culture media at certain passage has resulted in robust cell yield without compromising the quality of the MSCs.
Master Cell Bank
The "master cell bank" or MCB is generated from individual donors comprising of mesenchymal stromal cells that are fully characterized and cryopreserved.
Working Cell Bank
Cryopreserved MCB`s are thawed, cultured and expanded for generating a "working cell bank" or WCB. The WCB`s are thoroughly characterized according to our extensive QC criteria.
Production
For Stempeucel® production, appropriate numbers of WCB vials are thawed & expanded up to certain passages, harvested & characterized using a variety of parameters.
Therapeutic Indications
Critical Limb Ischemia due to Buerger`s Disease
Critical limb ischemia (CLI) due to Buerger`s disease is a major unmet medical need with a high incidence of morbidity.
CLI due to Peripheral Arterial Disease
Critical limb ischemia (CLI) due to PAD is a severe blockage in the arteries of the lower extremities, which markedly reduces blood flow.
Knee Osteoarthritis
It is also known as degenerative joint disease, is typically the result of wear and tear and progressive loss of articular cartilage.
Diabetic Foot Ulcer
Diabetic foot ulcer is a major complication of diabetes mellitus, and probably the major component of the diabetic foot.
ARDS due to COVID-19 Pneumonia
The most frequent cause of death following COVID-19 infection is Acute Respiratory Distress Syndrome (ARDS), which can be induced by the virus
Peri-anal Fistula
A major complication of Crohn`s disease leading to fistulous tracts in the peri-anal region