HUMSCs Combined With Col I to Third-Degree Burn Wound

ConditionsBurn Wounds Third-Degree Burn Wounds

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-65

SponsorThe First Affiliated Hospital of Xinxiang Medical College

About this trial

To evaluate the safety and tolerability of human umbilical cord mesenchymal stem cells combined with bovine type I collagen in the treatment of third-degree burn wounds.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-65 years, gender unrestricted

Confirmed third-degree burns, wound area 1%-5% TBSA

Admission within 72 hours after burn injury

Voluntarily signed informed consent

Disqualifiers

Pregnant or lactating females

Severe immunodeficiency or autoimmune disease

History of malignant tumor, or coagulation dysfunction

Severe cardiac, hepatic, or renal insufficiency

Trial design

Design model

Parallel

Treatments tested in this trial

HUMSCs combined with bovine type I collagen
Combination product
To evaluate the safety and tolerability of human umbilical cord mesenchymal stem cells combined with bovine type I collagen in the treatment of third-degree burn wounds
bovine type I collagen
Biological/Vaccine
To evaluate the safety and tolerability of bovine type I collagen in the treatment of third-degree burn wounds
Sterile blank dressing / Vaseline gauze
Device
To evaluate the safety and tolerability of sterile blank dressing / vaseline gauze in the treatment of third-degree burn wounds.

Treatment groups

108 Participants

are divided into 3 treatment groups

Group A: Combination Therapy GroupExperimental treatment 1 intervention

Group B: Collagen Control GroupActive comparator 1 intervention

Group C: Placebo GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

Re-epithelialization areas

Re-epithelialization will be determined by clinical evaluations and recorded by digital color photographs

Time frame

Up to 6 month

Complete burn wound healing

Time (days) to complete re-epithelialization of burned skin. It will be based on clinical evaluations and digital color photographs

Time frame

Up to 12 month

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Xinxiang Medical College

Lead sponsor

Source ClinicalTrials.gov

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