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
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
*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