MSC Gel — Mesenchymal Stem Cell Gel for Burn Wound Treatment
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| Trial ID | NCT07580755 ↗ |
|---|---|
| Sponsor | The First Affiliated Hospital of Xinxiang Medical College · China |
| Cell Source | msc · allogeneic |
| Indication | burn-wound |
| Phase | NA |
| Status | RECRUITING |
| Delivery Route | topical application (stem cell gel) |
| Enrollment | 90 |
| Publication | — |
Trial Design
This clinical trial evaluates the therapeutic efficacy and safety of a mesenchymal stem cell gel in patients with burn injuries. Participants are assigned to one of three groups: low-dose stem cell gel, high-dose stem cell gel, or gel-only control. As registered on ClinicalTrials.gov, the interventions are a low-dose stem cell gel group, a high-dose stem cell gel group, and a gel-only control group.
Clinical Significance
Burn wounds are a canonical indication for regenerative medicine, involving tissue injury, inflammation, infection risk, scar formation, and delayed re-epithelialisation occurring simultaneously. This study is notable for using MSCs not via intravenous infusion but as a gel applied directly to the wound site — a locally administered format.
Reasons MSC Gel is drawing attention:
- Topical regenerative therapy — stem cell gel applied directly to the injured area
- Dose-comparison design — low-dose and high-dose stem cell gel arms compared
- Gel-only control — designed to distinguish the effect of the gel vehicle from that of the cells it contains
- Wound healing indication — a field well suited to direct assessment of re-epithelialisation and tissue repair
Limitations and Discussion
The information available from the ClinicalTrials.gov registration alone is insufficient to confirm cell source, manufacturing method, cell count, gel composition, or development phase. Burn wound management also requires evaluation beyond the rate of re-epithelialisation — infection, scarring, pain, and long-term skin function recovery are all relevant outcomes. Quality control, viability, local retention time, and lot-to-lot consistency of cell-containing gel products remain important challenges.