Stempeutics

Therapeutics – Stempeucel®

Stempeucel® is the first ‘Made in India’ Cell Therapy to treat Critical Limb Ischemia (CLI)

ABOUT THE PRODUCT

Stempeucel®

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® also approved for the treatment of Knee Osteoarthritis (OA). other indication under development, Non healing Diabetics foot ulcer, Perianal Fistula due to Crohn's disease, Chronic Low Back pain due to Degenerative Disc Disease

HOW TO DIFFERNTIATE

Key Features & Differentiation

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.

PRODUCT USECASE

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.

Chronic Low Back Pain (CLBP)

CLBP is caused by damage to the disc as a result of ageing, genetics and injuries

Peri-anal Fistula

A major complication of Crohn's disease leading to fistulous tracts in the peri-anal region

Product Development Status

Critical Limb Ischemia due to Buerger's Disease

Critical Limb Ischemia due to Peripheral Arterial Disease

Knee Osteoarthritis

Diabetic Foot Ulcer

PAF due to Crohn's Disease

Chronic Low Back Pain

Indication

Basic R&D

Pre-Clinical

Phase 1

Phase 2

Phase 3

Marketing Authorization

*Current status of Clinical Trials: All clinical trials are approved by DCGI