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news.CardioCell is planning to proceed with finalizing a Phase IIb clinical trial protocol based on recommendations from a Heart Failure Advisory Board comprising cardiology key opinion leaders and its Scientific Advisory Board members.
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In a recent meeting members of both boards analyzed preliminary Phase IIa safety and efficacy data from CardioCell’s on-going chronic heart failure (HF) study, "Single-blind, Placebo-controlled, Crossover, Multi-center, Randomized Study to Assess the Safety, Tolerability and Preliminary Efficacy of a Single Intravenous Dose of Ischemia-tolerant Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Heart Failure of Non-ischemic Etiology" (NCT02123706).
Data from three months following a single infusion show signs of potential efficacy in the treated group in contrast to the control group. As a result, the group unanimously recommended that CardioCell expand the study into Phase IIb and designed new protocols to more definitely assess the effects of this novel intervention on cardiac function and the outcomes in patients with heart failure.
"Given the negative results of many trials conducted in patients with heart failure, innovation is required in this field. As a result of encouraging animal and clinical data, we are developing a robust Phase IIb program using CardioCell’s therapy," says Heart Failure Advisory Board Co-chair Dr. Mihai Gheorghiade, Professor of Medicine and Surgery and Director of Experimental Therapeutics at the Center for Cardiovascular Innovation at Northwestern University Feinberg School of Medicine.
The proposed Phase IIb study will include approximately 600 patients with heart failure and reduced ejection fraction due to coronary artery disease and/or primary cardiomyopathy.
Once the protocol is finalized and the FDA’s IND approval is received, the Phase IIa study centers – Northwestern University, Emory University, the University of Pennsylvania and Stony Brook University – will be asked to participate. In addition to those sites, CardioCell is in a process of identifying more sites in the United States to conduct this relatively large Phase IIb program.
Only CardioCell’s chronic HF therapies feature itMSCs, which are exclusively licensed from CardioCell’s parent company Stemedica. Unlike all other MSCs – which are grown under normoxic conditions – Stemedica’s bone-marrow-derived, adult, allogeneic itMSCs are unique because they are grown under hypoxic conditions. In vitro experiments demonstrate cells that are exposed to hypoxic conditions show greater homing and engraftment than cells grown under normoxic conditions.
Compared to other MSCs, itMSCs secrete higher levels of growth factors and other important proteins associated with neoangiogenesis and healing.