Safety and Preliminary Effectiveness Study of Mesenchymal Stem Cells, HeXell-2020, in Patients With Stable Coronary Artery Disease

StatusRecruiting
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 31, 2027 → Dec 31, 2028
See other at-risk trials from Hexun Biosciences Co., LTD.

Record History

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  1. Primary completion pushed from Dec 31, 2027 to Dec 31, 2028 Show 6 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Dec 1, 2025 to Aug 27, 2026
    • Study completion pushed from Jul 31, 2028 to Jul 31, 2029
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 2 of 12 entries
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
This is a phase I/IIa study to investigate the safety, tolerability, and preliminary effectiveness of HeXell-2020 in patients with stable coronary artery disease (CAD). HeXell-2020 is an investigational drug product consisting of allogenic umbilical cord mesenchymal stem cells (UCMSCs) as the drug substance. All enrolled and eligible subjects will receive HeXell-2020 treatment.
Trial Details
NCT Number NCT07137104
Lead Sponsor Hexun Biosciences Co., LTD.
Conditions
(from sponsor)		 Coronary Artery Disease
Related terms Coronary Artery Disease
Enrollment 39 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov