CellProThera and BioCardia announced an agreement to expand their current collaboration to the SIngXpand clinical trial in Singapore. The study will evaluate the safety and efficacy of in vitro expanded peripheral blood CD34+ stem cells output by the StemXpand automated process and delivered via BioCardia’s Helix biotherapeutic delivery system for the treatment of patients soon after a myocardial infarction.
Under the terms of the agreement, CellProThera will fund completion of all regulatory and clinical activities undertaken by both firms for the clinical investigation. If the study results in regulatory approval of the product, CellProThera will have exclusive commercial rights in Singapore to the Helix Biotherapeutic delivery system for the delivery of culture expanded CD34+ cells to treat patients who have had a recent myocardial infarction. BioCardia will receive double-digit royalty payments on future sales of the combination product.
A press release reports that published data has shown that delivery of stem cell therapy to the heart using the Helix system resulted in superior cell retention and fewer treatment emergent major adverse cardiac events than either percutaneous intracoronary infusion or direct injection using a straight needle. Additionally, peer reviewed literature on clinical trials of CD34+ cells have noted minimal adverse events, with potential benefit in the treatment of cardiac conditions. The published results of the pilot study conducted by CellProThera have shown meaningful improvement in cardiac functions after injection of CD34+ stem cells into the myocardium following myocardial infarction.