An interventional study of human umbilical cord mesenchymal stem cells and blank solvent in Skin Wound and Scar, Hypertrophic, sponsored by Fujian Medical University Union Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Fujian Medical University Union Hospital · Not applicable, Interventional, and Treatment
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:
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.
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.
129 studies on the registry are indexed under Cicatrix, Hypertrophic; 31 are open to participants now.
This study's planned enrollment of 88 is above the median of 36 across 106 interventional studies indexed under Cicatrix, Hypertrophic.
Browse Cicatrix, Hypertrophic studies →Fujian Medical University Union Hospital is the lead sponsor of 109 studies on the registry; 79 are open to participants now.
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Exclusion Criteria:
Participants who meet any of the following criteria are not suitable for inclusion:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: 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
Time frame: 12 months
Itching at wound site
It will be assessed at the time of presentation and at 12 months after the intervention using severity of pruritus scale. It is 4 point rating scale from 0 (no itch) to 3(severe itch disturbing the sleep) assessing severity of pruritus within 24-hours recall period. Pre and post intervention ratings will be compared and percentage increase or decrease in the rating will be documented.
Time frame: 12 months
Pain At scar Site
Patient will be asked to rate his/her current, best and worst pain level over past 24 hours on scale of 0 (no pain) to 10 (worst pain imaginable). Pain at scar site will be assessed at time of presentation and then at 12 months after start of the treatment. Pre and post intervention ratings will be compared and percentage increase or decrease in the rating will be documented. This scale is chosen due to its high feasibility and good compliance.
Time frame: 12 months
Started Oct 2021 (actual). Primary completion is estimated for Dec 2027, 74 months after the start.
Of 33 interventional studies with no phase under Cicatrix, Hypertrophic, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 30. This study's planned 74 months is above that.
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