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Umbilical Cord Stem Cells for Skin Grafts in Donor Site Wounds

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 3 months later Sep 1, 2025 → Dec 31, 2027
See other at-risk trials from Fujian Medical University Union Hospital

Record History

  1. Notable Primary completion pushed from Sep 1, 2025 to Dec 31, 2027
    • Study completion pushed from Oct 20, 2026 to Dec 31, 2027
    • Site contact updated
    v5
  2. Notable Primary completion date: Sep 1, 2024 to Sep 1, 2025
    • Study completion date: Oct 20, 2025 to Oct 20, 2026
    v4
  3. Notable Primary completion date: Sep 1, 2023 to Sep 1, 2024v3
  4. Minor Interventions: Control group (Procedure), hUCMSC group (Procedure) to blank solvent (Procedure), human umbilical cord mesenchymal stem cells (Procedure)v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
The goal of this clinical trial is to evaluate the safety and effectiveness of human umbilical cord mesenchymal stem cell (hUCMSC) therapy in patients undergoing medium-thickness skin grafts for donor site wounds. The study aims to answer the following main questions: * Question 1: Does hUCMSC therapy improve the healing quality and speed of donor site wounds in comparison to standard treatment? * Question 2: Does hUCMSC therapy reduce scar formation in the donor site wounds? Participants in this study will undergo medium-thickness skin grafts, and those in the treatment group will receive hUCMSC therapy. The main tasks for participants will involve regular follow-up visits, monitoring of wound healing progress, and assessment of any potential side effects or complications associated with the therapy. In order to evaluate the effectiveness of hUCMSC therapy, researchers will compare the treatment group receiving hUCMSC therapy with a control group that receives standard treatment alone. The aim is to determine if the use of hUCMSC therapy leads to improved healing outcomes and reduced scar formation compared to the standard treatment group.
Trial Details
NCT Number NCT05984628
Lead Sponsor Fujian Medical University Union Hospital
Conditions
(from sponsor)
Skin Wound, Scar, Hypertrophic
Related terms Cicatrix, Hypertrophic
Enrollment 88 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov