NCT05984628

Umbilical Cord Stem Cells for Skin Grafts in Donor Site Wounds

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Fujian Medical University Union Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

The donor site of the medium-thickness skin graft procedure usually forms scars or even hypertrophic scars, which significantly differ from normal skin physiology and cause discomfort to patients such as itching and burning sensations. Currently, the pathological mechanism of scar formation is not fully understood. There is a pressing clinical need for new methods to improve the healing quality and speed of donor site wounds in patients undergoing medium-thickness skin grafts and to reduce scar formation. It is well known that various types of stem cells from different sources are involved in the process of wound repair. Under the regulation of various signaling molecules and chemotactic factors, they migrate to the wound, proliferate, and differentiate into various cellular components of the skin, thus constructing new tissue structures and achieving wound healing. Stem cells possess powerful self-renewal and multi-directional differentiation abilities. Some stem cells have been successfully applied in the treatment of severe burn wounds and non-healing wounds, yielding promising results. Furthermore, in recent years, tissue engineering techniques have been used to combine stem cells with appropriate scaffolds to create tissue-engineered skin, utilizing the potential of stem cells for multi-directional differentiation and rapid expansion. This approach allows for rapid coverage and functional reconstruction of large-area wounds. Therefore, we also hope to enhance the healing quality of donor site wounds in patients undergoing medium-thickness skin grafts and inhibit excessive scar formation by utilizing stem cell technology. Among the various options, the use of human umbilical cord mesenchymal stem cells (UCMSC) is highly feasible for treating donor site wounds in medium-thickness skin graft procedures. UCMSC has abundant sources, easy collection, easy expansion, no harm to donors, no ethical controversies, potential for industrialization and standardized clinical treatment, and excellent biological characteristics. This study aims to investigate the safety and efficacy of human umbilical cord mesenchymal stem cell (hUCMSC) therapy for donor site wounds in medium-thickness skin grafts, as well as its effect in reducing scar formation.

Conditions

• Skin Wound
• Scar, Hypertrophic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-20
• Primary completion: 2025-09-01
• Completion: 2026-10-20
• First posted: 2023-08-09
• Last updated: 2025-07-02

Locations

1 site across 1 country: China