CellProThera and BioCardia have partnered for clinical trial and marketing in Singapore of early stem cell therapy for patients following myocardial infarction.
Image: CellProThera, BioCardia to trial stem cell therapy in patients following myocardial infarction. Photo: Courtesy of Photokanok/FreeDigitalPhotos.net.
The agreement expands the companies’ 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 heart attack.
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 suffered a recent heart attack. BioCardia will receive double-digit royalty payments on future sales of the combination product.
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 intra-coronary infusion or direct injection using a straight needle.
In addition, 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 heart attack.
Source: Company Press Release