US-based biotechnology company CardioCell has reported positive results from its Phase IIa clinical trial of ischemia-tolerant mesenchymal stem cells (itMSCs) for chronic heart failure (HF).
The stem cells are derived from bone marrow and are allogeneic, developed under chronic hypoxic conditions.
It generates a higher level of growth factors and other proteins related to neoangiogenesis and promote healing.
The Phase IIa trial was designed as a single-blind, placebo-controlled, crossover study intended to evaluate the safety and efficacy of the itMSCs through intravenous (IV) administration.
The study included 22 patients divided into a treatment group and a control group who received itMSCs through IV infusion and placebo.
A baseline change was tracked after 90 days and 180 days, and the assessment was done on the basis of a six-minute walk, Kansas City Cardiomyopathy Questionnaire (KCCQ), New York Heart Association (NYHA) and cardiac MRI.
Results suggested that the itMSCs demonstrated safety and tolerability while resulting in clinical improvements.
Additionally, the study also exhibited the efficacy of itMSCs in preventing inflammation considered responsible for HF progression and resulted in the reduction of natural killer (NK) cells.
Stony Brook University Heart Institute co-director cardiology division chief Dr Javed Butler said: “The study’s premise was that the stem cell benefits may be related to their paracrine properties.
“We hypothesised that these benefits should also be retained with IV administration, and, theoretically, enhanced in HF patients who do not have any evidence of myocardial scarring.
“The results support that IV administration is a safe and viable strategy that has the potential to offer significant health benefits.”
The IV itMSC administration is considered a more practical approach for offering health benefits.