Therapeutics – Stempeucel®
ABOUT THE PRODUCT
Stempeucel®
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HOW TO DIFFERNTIATE
Key Features & Differentiation
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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.
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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.
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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.
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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.
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Production
For Stempeucel® production, appropriate numbers of WCB vials are thawed & expanded up to certain passages, harvested & characterized using a variety of parameters.
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PRODUCT USECASE
Therapeutic Indications
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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.
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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.
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Knee Osteoarthritis
It is also known as degenerative joint disease, is typically the result of wear and tear and progressive loss of articular cartilage.
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Diabetic Foot Ulcer
Diabetic foot ulcer is a major complication of diabetes mellitus, and probably the major component of the diabetic foot.
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Chronic Low Back Pain (CLBP)
CLBP is caused by damage to the disc as a result of ageing, genetics and injuries
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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
ARDS due to COVID-19 Pneumonia
PAF due to Crohn's Disease
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
*COVID-19 ARDS trial is on hold due to drop in the number of cases
*COVID-19 ARDS trial is on hold due to drop in the number of cases