Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT05984628

Umbilical Cord Stem Cells for Skin Grafts in Donor Site Wounds

Led by Fujian Medical University Union Hospital · Updated on 2025-07-02

88

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Umbilical Cord Stem Cells for Skin Grafts in Donor Site Wounds

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients between 18 and 60 years old with extensive scars, large benign tumors, or fresh wounds on the body surface
  • Patients undergoing medium-thickness skin graft surgery with donor sites from the thigh, abdomen, or back
  • Participants who understand the study purpose, risks, benefits, and rights, and agree to participate and cooperate fully
Not Eligible

You will not qualify if you...

  • History of hypertension, hypotension, or heart diseases including myocardial ischemia, coronary heart disease, or myocarditis
  • Liver or kidney dysfunction
  • Infectious diseases such as viral hepatitis, syphilis, or HIV/AIDS
  • Venous thrombosis, thoracic or abdominal aortic aneurysm, or aortic dissection
  • Blood disorders including abnormal coagulation, anemia, leukemia, polycythemia vera, or aplastic anemia
  • Allergic conditions such as urticaria, bronchial asthma, or multiple drug/food allergies
  • Respiratory diseases like chronic bronchitis, emphysema, bronchiectasis, respiratory failure, COPD, or interstitial pneumonia
  • Digestive diseases including severe gastric or duodenal ulcers, chronic gastritis, or chronic pancreatitis
  • Urinary diseases such as chronic urinary tract infections, nephritis, or nephrotic syndrome
  • Endocrine diseases including hyperthyroidism, diabetes, acromegaly, pituitary or adrenal diseases, or diabetes insipidus
  • Organic neurological or psychiatric disorders including encephalitis, traumatic brain injury sequelae, epilepsy, schizophrenia, hysteria, depression, severe insomnia, or neurasthenia
  • Chronic skin diseases especially infectious, allergic, or inflammatory systemic skin diseases like extensive eczema, pemphigus, or pemphigoid
  • Autoimmune and collagen diseases such as systemic lupus erythematosus, dermatomyositis, or scleroderma
  • History of long-term smoking, alcohol abuse, or drug addiction
  • History of major surgeries such as gastric, lung, spleen, kidney, or liver resection
  • History of other significant malignant tumors
  • Blood donation or organ transplantation within the past 5 years
  • Pregnancy, lactation, menstrual period, or within one year after ending pregnancy
  • Previous rejection for voluntary blood donation
  • Other conditions deemed unsuitable by investigators

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Trial Site Locations

Total: 1 location

1

Chenxiaosong

Fujian, Fuzhou, China, 350001

Actively Recruiting

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Research Team

X

xiaosong chen, director

CONTACT

X

xiaosong xiaosong, director

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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