Skin burns. MedDRA version: 20.0 Level: LLT Classification code 10039798 Term: Second degree burns System Organ Class: 100000004863
Conditions
Interventions
Product Name: Allogeneic (culture-expanded and cryopreserved) adipose-derived mesenchymal stem cells
Product Code: CSCC_ASC2210
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: see
Sponsors
Dept. of Plastic Surgery and Burns Treatment, Copenhagen University Hospital Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: whether treatment with allogeneic adipose-derived stem cells (ASCs) can promote healing of skin burns. ;Secondary Objective: whether treatment with allogeneic ASCs can limit the extent of tissue damage of skin burns.;Primary end point(s): the burn’s degree of healing. ;Timepoint(s) of evaluation of this end point: within week 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2: Rate of healing 3: Microscopic examination of a biopsy 4: Blood perfusion 5: Quality of healing at outpatient follow-ups ;Timepoint(s) of evaluation of this end point: 2: within week 1. 3: within week 2. 4: serial time points within week 2. 5: within 6 months. | — |
Countries
Denmark
Contacts
Public ContactRigshospitalet 2102
Dept. of Plastic Surgery & Burns Treatment, Copenhagen University Hospital Rigshospitalet
Outcome results
None listed