Umbilical Cord Stem Cells for Skin Grafts in Donor Site Wounds

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05984628
Study type	Interventional
Source	Fujian Medical University Union Hospital
Contact	xiaosong chen, director
Phone	13365910035
Email	chenxiaosong74@163.com
Status	Recruiting
Phase	N/A
Start date	October 20, 2021
Completion date	October 20, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03947450` - Autologous Volar Fibroblast Injection Into the Stump Site of Amputees	Phase 2
Completed	`NCT01437852` - StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns	Phase 1
Active, not recruiting	`NCT03649308` - Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting	N/A
Completed	`NCT05112679` - Limb Health and Socket Pressure in Response to Powered Ankle Protheses	N/A
Completed	`NCT03795116` - Light Emitting Diode-Red Light (LED-RL) Phototherapy for Skin Scarring Prevention	Phase 2
Recruiting	`NCT04557761` - Comparison of microMend® Devices to Sutures in Closing Lacerations in Children	N/A
Active, not recruiting	`NCT03394612` - Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Full-Thickness Skin Defects in Adults and Children	Phase 2
Withdrawn	`NCT05643755` - Preoperative Image-based Education Effect on Postoperative Satisfaction of Patients Undergoing First-time Dermatologic Surgery	N/A
Completed	`NCT03754218` - Amnion Wound Covering for Enhanced Wound Healing	Early Phase 1
Active, not recruiting	`NCT05517902` - StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects	Phase 3
Terminated	`NCT03005054` - StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects	Phase 2
Completed	`NCT06352853` - Scalpel Versus Diathermy in Transverse Abdominal Skin Incision During Cesarean Section	N/A
Completed	`NCT03960164` - Dermal Regeneration Photosynthetic Matrix	Early Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.