2 November 2018 - - France-based cell therapy product developer CellProThera and US-based regenerative biologic therapies developer BioCardia (OTC: BCDA) have inked an agreement to expand their current collaboration to the SIngXpand Clinical Trial in Singapore, the companies said.

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.

CellProThera, headquartered in Mulhouse, France, is developing a cell therapy product for the regeneration of the damaged heart shortly after a severe heart attack.

CellProThera has developed a proprietary technology to expand human peripheral blood CD34+ cells and turn them into a stem cell graft ProtheraCytes.

The graft is then directly injected into the heart tissue of the patient during a minimally invasive procedure.

A randomised phase I/IIb clinical trial is currently ongoing in several centres in France and in the UK. The innovative approach developed by CellProThera is viewed by experts as one of the most promising to treat AMI and potentially prevent the occurrence of chronic heart failure.

BioCardia, Inc., headquartered in San Carlos, California, is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP and CardiALLO cell therapies are the company's biotherapeutic product candidates in clinical development.

The company's current products include the Helix Biotherapeutic Delivery System and the Morph steerable guide and sheath catheter portfolio.

BioCardia also partners with other biotherapeutic companies to provide its Helix systems and clinical support to their programmes studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction.

CardiAMP cell therapy uses a patient's own (autologous) bone marrow cells to potentially stimulate the body's natural healing response through a minimally-invasive, catheter-based procedure.

The Helix Biotherapeutic Delivery System is known as the Helical Infusion Catheter outside of the United States.