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CardioCell gets IND approval from FDA

San Diego-based CardioCell LLC on Wednesday received the Food and Drug Administration’s investigational new drug (IND) approval for a phase 2a clinical study using its allogeneic stem-cell therapy to treat subjects with chronic heart failure (CHF).

Preparation is underway to initiate the study at Emory University, Northwestern University and the University of Pennsylvania in May.

“With the FDA’s IND approval, CardioCell is pleased to proceed with a Phase 2a CHF clinical trial based on the safety data reported in previous clinical trials using our unique, hypoxically grown stem cells,” says Dr. Sergey Sikora, Ph.D., CardioCell’s president and CEO. “At the study’s conclusion we will understand if our therapy produces signs of improvement in a population of patients with dilated CHF, a condition largely unaddressed by current therapies. Dilated CHF is characterized by a viable but non-functioning myocardium in which cardiomyocytes are alive but are not contracting as they should. We hope that unique properties of our itMSCs will transition patients’ cardiomyocytes from viable to functioning, eventually improving or restoring heart function.”

Only CardioCell’s CHF therapies feature itMSCs, which are exclusively licensed from CardioCell’s parent company Stemedica Cell Technologies Inc. Unlike all other MSCs -- which are grown under normoxic conditions -- Stemedica’s bone-marrow-derived, allogeneic itMSCs are unique because they are grown under hypoxic conditions that more closely resemble the environment in which they live in the body. Compared to other MSCs, itMSCs secrete higher levels of growth factors usually associated with angiogenesis and healing. The current CHF study has been designed to help determine if CardioCell’s itMSC-based therapies stimulate the transition of viable but non-functioning myocardium into functioning myocardium.

CHF generates more than 1 million hospitalizations annually.

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