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Study on the efficacy and safety of allogeneic epidermal cell membrane and freeze-dried products in burn wound and skin donor area

Study on the efficacy and safety of allogeneic epidermal cell membrane and freeze-dried products in burn wound and skin donor area

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079745
Enrollment
Unknown
Registered
2024-01-11
Start date
2024-01-12
Completion date
Unknown
Last updated
2024-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns

Interventions

Active cell membrane group:Covering a membrane infiltrated with active allogeneic cells
Freeze-dried cell membrane group:Covering a membrane infiltrated with freeze-dried allogeneic cells

Sponsors

Department of Burns and Plastic Surgery, The Fourth Medical Center of Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ? The burn area is within the range of 1%-30%TBSA, and the single observable wound surface is not less than 8×8 cm2.? Selected patients should be voluntary, fully understand and voluntarily sign informed consent.?Age 18-60 years old, gender is not limited.? Outpatient or inpatient, within 5 days after injury.? Female patients of childbearing age should have effective contraceptive methods during the trial.

Exclusion criteria

Exclusion criteria: ? Patients with a clear history of malignant tumors, AIDS, autoimmune diseases, and organ transplantation.? Pregnant or lactating patients.? Patients with myocardial infarction and cerebrovascular accident within 6 months.?According to the comprehensive evaluation of the researchers, the poor willingness of patients and their families to treat the disease may lead to the risk of trial termination.? A comprehensive assessment by the researcher found that patients and their families could not accept the possible situation related to poor quality of life caused by scars after successful treatment.? Patients with poor systemic condition, multiple organ failure, serious systemic infection and severe wound infection, etc., the researchers comprehensively evaluated that the condition was unstable or the wound had no skin ability.?Other conditions deemed unsuitable for inclusion by the investigator.? Patients with simultaneous use of recombinant human epidermal growth factor gel as a wound treatment drug.

Design outcomes

Primary

MeasureTime frame
Wound surface measurement index;Wound healing effect;

Secondary

MeasureTime frame
Biochemical index detection;

Countries

China

Contacts

Public ContactChuanan Shen

The Fourth Medical Center of Chinese PLA General Hospital

shenchuanan@126.com+86 139 1059 5595

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026