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Recruiting NCT07580755

Mesenchymal Stem Cells in the Treatment of Burn Wounds

No phase Interventional Burn Injury Burn Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: low-dose stem cell gel group, high-dose stem cell gel group, with only the gel.
Who it may be relevant to
Registry conditions: Burn Injury, Burn Patients. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized Controlled Study on the Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Extensive Burns

Overview

Burn patients were randomly divided into the low-dose stem cell gel group, the high-dose stem cell gel group, and the placebo group (with only the gel), and received the same treatment under the same conditions simultaneously.

Detailed description

This study adopted a randomized, double-blind, parallel-controlled research method. It planned to enroll 90 burn patients who underwent autologous thick skin transplantation. These patients were randomly divided into the low-dose stem cell gel group, the high-dose stem cell gel group, and the placebo group (with only the gel), with 30 patients in each group. The three groups of subjects received the same treatment under the same conditions simultaneously.

Interventions

  • Combination product low-dose stem cell gel group
    Using hydrogels containing low-doses of placenta-derived mesenchymal stem cells as wound dressings to promote wound healing in burn patients after thick skin grafting
  • Combination product high-dose stem cell gel group
    Using hydrogels containing or without differenthigh-doses of placenta-derived mesenchymal stem cells as wound dressings to promote wound healing in burn patients after thick skin grafting
  • Other with only the gel
    Using only hydrogels as wound dressings to promote wound healing in burn patients after thick skin grafting

Primary outcome measures

  • Re-epithelialization areas [Time frame: Up to 6 month]
  • Complete burn wound healing [Time frame: Up to 12 month]

Eligibility criteria

Inclusion criteria

  • Voluntary participation and signing of the informed consent form;
  • Burn patients, subjects requiring autologous skin grafting;
  • Age 18 to 65 years old, gender not restricted;
  • During this clinical study, single person, single donor skin area (lateral thigh or trunk) treatment;
  • Skin burn area < 30% of total body surface area (TBSA);
  • The donor skin area is the first time for donation, and the donor skin area is medium-thick skin (thickness approximately 0.4mm);
  • The area of the excised skin flap ≥ 90 cm2;
  • Able to cooperate with this study protocol and accept regular postoperative follow-up visits.

Exclusion criteria

  • Those allergic to sodium alginate (gel component);
  • Electric shock injuries, chemical burns, radiation injuries or combined with other traumas;
  • Subjects with severe systemic diseases (judged by the researchers);
  • Subjects with uncontrolled hypertension or diabetes (judged by the researchers);
  • Pregnant or lactating women;
  • Subjects whose condition may affect the study assessment or require the concurrent use of medical treatments that may affect the efficacy assessment;
  • Subjects with acute or chronic kidney diseases, renal failure or serum creatinine level = 1.5 times the upper limit of normal value;
  • Subjects with acute or chronic liver diseases, total bilirubin, alanine aminotransferase, aspartate aminotransferase = 2.0 times the upper limit of normal value;
  • Subjects with a history of malignant tumors;
  • Subjects who have participated in other clinical studies for less than 3 months;
  • Subjects with mental disorders and without self-awareness, unable to express clearly;
  • Subjects using immunosuppressants and those who have been using corticosteroids for a long time (more than 1 month) (excluding local application);
  • Subjects with infectious diseases (any one of the four items positive in the test);
  • Subjects with other severe systemic diseases;
  • Other subjects that the researchers consider not eligible for inclusion.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Xinxiang Medical College — Xinxiang

Identifiers

NCT: NCT07580755 · MSCBW-2022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗