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Umbilical Cord Stem Cells for Skin Grafts in Donor Site Wounds

NCT05984628 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-07-02

No results posted yet for this study

Summary

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.

Conditions

  • Skin Wound
  • Scar, Hypertrophic

Interventions

PROCEDURE

human umbilical cord mesenchymal stem cells

After the completion of the donor site harvesting in the experimental group, allogeneic umbilical cord mesenchymal stem cells are injected into the deep layer of the de-epithelialized area and the surrounding 0.5cm subcutaneous region. After the injection, the wound is covered and dressed with conventional dressings.

PROCEDURE

blank solvent

After the completion of the donor site harvesting in the experimental group, the de-epithelialized area and the surrounding 0.5cm subcutaneous region is injected an equal volume of blank solvent for stem cell suspension in the control group. After the injection, the wound is covered and dressed with conventional dressings.

Sponsors & Collaborators

  • Fujian Medical University Union Hospital

    lead OTHER

Principal Investigators

  • xiaosong xiaosong, xiaosong · Affiliated Union Hospital of Fujian Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-20
Primary Completion
2025-09-01
Completion
2026-10-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05984628 on ClinicalTrials.gov