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A Study to Evaluate the Safety and Efficacy of In Vitro Expanded Peripheral Blood CD34+ Stem Cells Output by the StemXpand Automated Process and Delivered via Helix Biotherapeutic Delivery System for the Treatment of Patients Soon After a Heart Attack

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Trial Profile

A Study to Evaluate the Safety and Efficacy of In Vitro Expanded Peripheral Blood CD34+ Stem Cells Output by the StemXpand Automated Process and Delivered via Helix Biotherapeutic Delivery System for the Treatment of Patients Soon After a Heart Attack

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 10 Nov 2018

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At a glance

  • Drugs Endothelial stem cell therapy CellProThera (Primary)
  • Indications Myocardial infarction
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms SIngXpand
  • Sponsors CellProthera

    • Most Recent Events

    • 10 Nov 2018 New trial record
    • 30 Oct 2018 According to a BioCardia media release, 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.
    • 30 Oct 2018 According to a BioCardia media release, CellProThera and BioCardia have announced an agreement to expand their current collaboration to the SIngXpand Clinical Trial in Singapore.Under the terms of the agreement, CellProThera will fund completion of all regulatory and clinical activities undertaken by both firms for the clinical investigation.
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