Umbilical Cord Stem Cells for Skin Grafts in Donor Site Wounds

NCT05984628 | Recruiting DMC

• 1 other identifier: 2020GXB001-01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hUCMSC; Skin Wound; Scar, Hypertrophic; Stem cell

Outcome Measures

Primary Outcomes (2)

• Time to epithelialization of the skin wound

  Record the size of the donor site wound at each follow-up time point and document it with photographs.

  12 months

• Observation of scar formation

  Record the height and erythema of the donor site scar at each follow-up time point and document them with photographs. It will be assessed using, Vancouver scar scale at time of presentation and at 12 months after the intervention. Pre and post intervention ratings will be compared and percentage increase or decrease in the rating will be documented. Vancouver Scar Scale is a 13 points scale and includes four parameters, pigmentation, vascularity pliability and height of scar.13 It is an objective scale and examining doctor will assess and record score out of 13. Lesser the score better is the scar

  12 months

Secondary Outcomes (2)

• Itching at wound site

  12 months

• Pain At scar Site

  12 months

Study Arms (2)

human umbilical cord mesenchymal stem cells

EXPERIMENTAL

Injection of human umbilical cord mesenchymal stem cells (hUCMSC) into the donor site. 1. Dosage of stem cell preparation: Calculated based on the area of the donor site, with a cell count of 1X10\^5cells/cm2. 2. Administration method: The cells are prepared as an injectable suspension using a blank solvent for stem cells at a concentration of 1X10\^6 cells/ml (0.1 ml/cm2). 3. Timing of administration: Administered immediately after completion of the donor site harvesting procedure. 4. Treatment duration: The stem cell administration is a single dose, administered at the specified timing as described above

Procedure: human umbilical cord mesenchymal stem cells

blank solvent

PLACEBO COMPARATOR

Injection of an equal volume of blank solvent for suspension of stem cells into the donor site. 1. Dosage of Control group preparation: Calculated based on the area of the donor site. 2. Administration method: Injection of an equal volume of blank solvent for suspension of stem cells into the donor site. 3. Timing of administration: Administered immediately after completion of the donor site harvesting procedure. 4. Treatment duration: The Control group administration is a single dose, administered at the specified timing as described above

Procedure: blank solvent

Interventions

human umbilical cord mesenchymal stem cells PROCEDURE

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.

human umbilical cord mesenchymal stem cells

blank solvent PROCEDURE

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.

blank solvent

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients between 18 and 60 years old with extensive scars, large benign tumors, or fresh wounds on the body surface.
• Patients who undergo medium-thickness skin graft surgery (donor site can be from the thigh, abdomen, or back).
• Participants who have a thorough understanding of the study objectives, significance, implementation plan, potential benefits, risks involved, measures to address risks, and the rights and obligations of the subjects (including privacy protection and the right to withdraw), and are willing to participate in this clinical study and can cooperate effectively.

You may not qualify if:

• Hypertension, hypotension, heart disease (including history of myocardial ischemia, coronary heart disease, myocarditis).
• Liver or kidney dysfunction.
• Infectious diseases (including viral hepatitis, syphilis, HIV/AIDS, etc.).
• Venous thrombosis, thoracic or abdominal aortic aneurysm, aortic dissection.
• Blood disorders (abnormal coagulation function, anemia, leukemia, polycythemia vera, aplastic anemia, etc.).
• Allergic conditions (urticaria, bronchial asthma, history of allergic reactions to two or more drugs or foods).
• Respiratory system diseases (chronic bronchitis, emphysema, bronchiectasis, respiratory failure, chronic obstructive pulmonary disease, interstitial pneumonia).
• Digestive system diseases (severe gastric or duodenal ulcers, chronic gastritis, chronic pancreatitis).
• Urinary system diseases (chronic urinary tract infections, nephritis, nephrotic syndrome).
• Endocrine system diseases (hyperthyroidism, diabetes, acromegaly, pituitary diseases, adrenal diseases, diabetes insipidus).
• Organic neurological disorders or psychiatric illnesses (encephalitis, sequelae of traumatic brain injury, epilepsy, schizophrenia, hysteria, depression, severe insomnia, neurasthenia).
• Chronic skin diseases (especially infectious, allergic, and inflammatory systemic skin diseases, such as extensive eczema, pemphigus, pemphigoid).
• Autoimmune diseases and collagen diseases (such as systemic lupus erythematosus, dermatomyositis, scleroderma).
• History of long-term smoking, alcohol abuse, or drug addiction.
• History of major surgeries (such as gastric, lung, splenic, renal, or liver resection).

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Chenxiaosong

Fujian, Fuzhou, 350001, China

RECRUITING

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• xiaosong xiaosong, xiaosong

  Affiliated Union Hospital of Fujian Medical University

  STUDY CHAIR

Central Study Contacts

xiaosong chen, director

CONTACT

13365910035; chenxiaosong74@163.com

xiaosong xiaosong, director

CONTACT

13365910035; chenxiaosong74@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The efficacy evaluation component is conducted in a blinded manner, meaning that the assessors of efficacy outcomes are composed of plastic surgeons who are not members of the research team, have not participated in the intervention, and are unaware of the group allocation of the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Plastic Surgery and Regenerative Medicine

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: August 9, 2023
• Study Start: October 20, 2021
• Primary Completion: September 1, 2025
• Study Completion (Estimated): October 20, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

CN (1)