Our Science

About MKC

We are in-licensing IP and Technology for our first regenerative medicine portfolio which has led to approval of commercially marketed therapeutics in India for three different indications: Osteo-Arthritis (OA) of the knee; and Critical Limb Ischemia due to Buerger’s Disease and Atherosclerotic peripheral arterial disease.

Our technology licensing partner has recently completed randomized blinded phase 3 trial for a fourth indication of Diabetic Foot Ulcers at Plantar location and is currently unblinding / analyzing the data. All four products are derived from a robust, scalable, pooled allogeneic bone-marrow derived Mesenchymal Stromal Cell (MSC) therapy platform.

Pooling overcomes limitation of Product made from individual donors, resulting in homogeneous characteristics with ability to expand in prolonged culture while maintaining trilineage differentiation potential resulting in manufacture of significantly larger number of Doses from single starting GMP cell bank; with said Drug Product having desired potency, as measured by strong immuno-modulatory bioactivity and broad cytokine / growth factors secretion profile, and thereby resulting in durable clinically-meaningful efficacy outcomes.

The Drug Product is hypothesized to work via mechanisms of immunomodulation of disease environment to halt / reverse progression of disease and create a quasi-niche to facilitate regeneration of lost / damaged cells & tissues.

Regenerative Medicine

Regenerative medicine is a field of medicine that aims to replace or reboot tissues or organs damaged by disease, injury, or age.

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Mechanism of Action

The Drug Product is hypothesized to work via mechanisms of immunomodulation of disease environment to halt / reverse progression of disease and create a quasi-niche to facilitate regeneration of lost / damaged cells & tissues.

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Mesenchymal Stromal Cells (MSC): In-licensed Platform

MSC are the in vivo pharmacy within the body that migrate to areas of inflammation, injury or disease and immuno-modulate the disease environment to permit repair / regeneration.

MSCs possess broad immunomodulatory properties that are displayed on any immune cell population through either cell-cell contact (Fas/FasLigand cognate interaction, programmed Death1 system; notch pathway; toll like receptors) or through the production of an array of bioactive molecules (as detailed in proximity of the lines) and extracellular vesicles that function as cargo of soluble mediators, including nucleic acids, mitochondria, growth factors, cytokines and lipids.

The end result is the creation of a micro-environment—called “quasi-niche”—that stimulate a phenotypic switch of the target cells.

In addition, engulfment of apoptotic bodies by macrophages, upon killing of MSCs from activated NK- and T-cells, results in the switch of macrophages towards a tolerogenic profile.

Taken together, these events explain why the duration of the therapeutic effects of MSCs exceeds their survival in the host.

Ref: Ciccociopoppo R. et al. Developing Cell Therapies as Drug Products. Br J Pharmacol 178 (2), Jan 2021

Technology Platform

Current products are derived from a robust, scalable, pooled allogeneic bone-marrow derived Mesenchymal Stromal Cell (MSC) therapy platform, in-licensed from Stempeutics.

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Value-add of in-licensed Pooling Technology & IP

Stempeutics Proprietary Pooling Technology makes it best-in-Class. Stempeucel® has been demonstrated to be safe in over 350 patients across multiple clinical trials

Reduces Donor-donor Variability

Pooling of donors reduces donor-donor variability as experienced in other products. Regulatory agencies have expressed serious concerns in reproducibility when a single donor product is used.

Robust Large-scale Production

Pooling donors allows for larger scale of production thus enabling robust large-scale production and reducing lot to lot variability.

Broader Cytokines/ Growth Factor Array

Pooling of donors provides a larger cytokine/growth factor expression profile thus increasing the therapeutic potential. Dependency of an individual donor to provide the optimal profile is eliminated

Low Cost of Production

Large scale production reduces cost of production with significant savings in facilities, personnel and quality control lot release tests (safety and characterization) related costs.

Proprietary Patented Process

The unique and non-obvious benefits of pooling have led to a granted patent protecting Stempeutics' approach in 18 countries including US, EU and Japan.

Pooling overcomes limitation of Product made from individual donors, resulting in homogeneous characteristics with ability to expand in prolonged culture while maintaining trilineage differentiation potential resulting in manufacture of significantly larger number of Doses from single starting GMP cell bank; with said Drug Product having desired potency, as measured by strong immuno-modulatory bioactivity and broad cytokine / growth factors secretion profile, and thereby resulting in durable clinically-meaningful efficacy outcomes.

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The patented manufacturing process of " Stempeucel®" includes a unique process of multiple cell bank generation from which the Investigational Medicinal Product (IMP) is produced. Unique cell seeding densities are used for the preparation of various cell bank generations. The addition of growth factors to culture media at certain passage has resulted in robust cell yield without compromising the quality of the MSCs.

The "master cell bank" or MCB is generated from individual donors comprising of mesenchymal stromal cells that are fully characterized and cryopreserved. Next, cryopreserved MCB's are thawed, cultured and expanded for generating a "working cell bank" or WCB. The WCB's are also thoroughly characterized according to our extensive QC criteria prior to cryopreservation. For Stempeucel® manufacturing, appropriate numbers of WCB vials are thawed and expanded up to certain passages, harvested and characterized using a variety of parameters necessary to establish the sterility, identity and potency of the product.

CMC & Manufacturing

The "master cell bank" or MCB is generated from individual donors comprising of mesenchymal stromal cells that are fully characterized and cryopreserved. Next, cryopreserved MCB's are thawed, cultured and expanded for generating a "working cell bank" or WCB. The WCB's are also thoroughly characterized according to our extensive QC criteria prior to cryopreservation. For Stempeucel® manufacturing, appropriate numbers of WCB vials are thawed and expanded up to certain passages, harvested and characterized using a variety of parameters necessary to establish the sterility, identity and potency of the product.


The patented manufacturing process of "Stempeucel®" includes a unique process of multiple cell bank generation from which the Investigational Medicinal Product (IMP) is produced. Unique cell seeding densities are used for the preparation of various cell bank generations. The addition of growth factors to culture media at certain passage has resulted in robust cell yield without compromising the quality of the MSCs.


We are currently engaged in discussions with Partners & GMP CDMOs to manufacture new qualified US donor derived allogeneic cell banks and representative lots of drug product and demonstrate in vitro comparability to the Drug Product from Indian Donor banks that has been used in treatment of many hundreds of patients in clinical trials and now commercially in India. This new US Donor-derived Drug Product will be used for patient treatment in US/Europe clinical trials under appropriate INDs/CTAs.

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