Stem cells in the treatment of burns
Phase 1
- Conditions
- Skin burns.MedDRA version: 20.0Level: LLTClassification code 10039798Term: Second degree burnsSystem Organ Class: 100000004863Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
- Registration Number
- EUCTR2018-002870-27-DK
- Lead Sponsor
- Dept. of Plastic Surgery and Burns Treatment, Copenhagen University Hospital Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Age =18 years, of either gender
- Patients with deep dermal burns
- The intervention must be possible to be initiated within a defined time of the acquired burn injury
- Signs informed consent to participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Previous cancer, except treated non-melanoma skin cancer
- Systemic therapies altering wound healing
- Known hypersensitivity to used substances
- Pregnancy or breastfeeding
- Incapacity to give informed consent
- Withdrawal of informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method