Safety and Tolerability Study of Mesenchymal Stem Cells, HeXell-2020, in Elderly Subjects With Mild to Moderate Frailty Syndrome

StatusNot Yet Recruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 11 months later Jan 31, 2028 → Dec 31, 2028
See other at-risk trials from Hexun Biosciences Co., LTD.

Record History

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  1. Primary completion pushed from Jan 31, 2028 to Dec 31, 2028 Show 4 more changesShow less
    • Start date: Jan 31, 2026 to Dec 31, 2026
    • Study completion pushed from Jul 31, 2028 to Jul 31, 2029
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints: details revised at 6 of 7 entries
  2. Secondary endpoints: details revised at 1 of 7 entriesv2
  3. 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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a phase I study to investigate the safety, and Tolerability of HeXell-2020 in Elderly Subjects with Mild to Moderate Frailty Syndrome. 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 NCT07144072
Lead Sponsor Hexun Biosciences Co., LTD.
Conditions
(from sponsor)		 Frailty in Older Adults
Related terms Frailty
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov