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RECRUITING

NCT05984628

Umbilical Cord Stem Cells for Skin Grafts in Donor Site Wounds

Sponsor: Fujian Medical University Union Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2021-10-20

Completion Date

2026-10-20

Last Updated

2025-07-02

Healthy Volunteers

Yes

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.

Inclusion Criteria: 1. Patients between 18 and 60 years old with extensive scars, large benign tumors, or fresh wounds on the body surface. 2. Patients who undergo medium-thickness skin graft surgery (donor site can be from the thigh, abdomen, or back). 3. 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. Exclusion Criteria: Participants who meet any of the following criteria are not suitable for inclusion: 1. Hypertension, hypotension, heart disease (including history of myocardial ischemia, coronary heart disease, myocarditis). 2. Liver or kidney dysfunction. 3. Infectious diseases (including viral hepatitis, syphilis, HIV/AIDS, etc.). 4. Venous thrombosis, thoracic or abdominal aortic aneurysm, aortic dissection. 5. Blood disorders (abnormal coagulation function, anemia, leukemia, polycythemia vera, aplastic anemia, etc.). 6. Allergic conditions (urticaria, bronchial asthma, history of allergic reactions to two or more drugs or foods). 7. Respiratory system diseases (chronic bronchitis, emphysema, bronchiectasis, respiratory failure, chronic obstructive pulmonary disease, interstitial pneumonia). 8. Digestive system diseases (severe gastric or duodenal ulcers, chronic gastritis, chronic pancreatitis). 9. Urinary system diseases (chronic urinary tract infections, nephritis, nephrotic syndrome). 10. Endocrine system diseases (hyperthyroidism, diabetes, acromegaly, pituitary diseases, adrenal diseases, diabetes insipidus). 11. Organic neurological disorders or psychiatric illnesses (encephalitis, sequelae of traumatic brain injury, epilepsy, schizophrenia, hysteria, depression, severe insomnia, neurasthenia). 12. Chronic skin diseases (especially infectious, allergic, and inflammatory systemic skin diseases, such as extensive eczema, pemphigus, pemphigoid). 13. Autoimmune diseases and collagen diseases (such as systemic lupus erythematosus, dermatomyositis, scleroderma). 14. History of long-term smoking, alcohol abuse, or drug addiction. 15. History of major surgeries (such as gastric, lung, splenic, renal, or liver resection). 16. History of other significant malignant tumors. 17. Blood donation or organ transplantation within the past 5 years. 18. Pregnancy, lactation, menstrual period, or within 1 year after termination of pregnancy. 19. Previous circumstances of being rejected for voluntary blood donation. 20. Other situations deemed unsuitable for participation in this study by the investigators.

Locations (1)

Chenxiaosong

Fujian, Fuzhou, China