Using stem cells from umbilical cords to improve healing of skin graft donor sites

Umbilical Cord Stem Cells for Skin Grafts in Donor Site Wounds

This study is testing whether using stem cells from umbilical cords can help people heal better and faster from skin graft donor sites compared to standard treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 88 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Fujian Medical University Union Hospital (Academic / other)
• Locations: 1 site (Fujian, Fuzhou)
• Trial ID: NCT05984628 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of human umbilical cord mesenchymal stem cell (hUCMSC) therapy for patients undergoing medium-thickness skin grafts. Participants will receive either hUCMSC therapy or standard treatment, with the study focusing on the healing quality and speed of donor site wounds, as well as the reduction of scar formation. Regular follow-up visits will monitor wound healing progress and any potential side effects. The trial aims to address the clinical need for improved healing methods in skin graft procedures.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 60 with extensive scars or fresh wounds requiring medium-thickness skin grafts.

Not a fit: Patients with significant cardiovascular, liver, or kidney issues, or infectious diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly enhance healing and reduce scarring for patients undergoing skin grafts.

How similar studies have performed: While the use of stem cells in wound healing has shown promise in other studies, this specific application of hUCMSC therapy is relatively novel.

Eligibility criteria

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.

Where this trial is running

Fujian, Fuzhou

• Chenxiaosong — Fujian, Fuzhou, China (Recruiting)

Study contacts

• Study coordinator: xiaosong chen, director

Conditions Skin Wound; Scar, Hypertrophic; hUCMSC; Stem cell