ADRC001 for Hypertrophic scarring

Inclusion criteria

• {"criterion_text":"- Adults ≥ 18 years of age\n- Hypertrophic scars (age of scar > 2 years) after burn injuries on the front trunk or extremities.\n- Three uniform 6 cm x 6 cm areas of burn scar tissue on the front of the thorax or extremities. The scar should be large enough to separate the areas with a minimum of two centimeters.\n- BMI > 22 and enough abdominal fat for a minor liposuction.\n- Ability to understand information about the project."}

Exclusion criteria

• {"criterion_text":"- Significant comorbidities or lack of cognitive abilities to follow instructions.\n- Not being able to participate due to language or other personal issues.\n- Contraindications for abdominal liposuction.\n- Pregnancy or breastfeeding\n- Current or previous steroid therapy (systemic or local) within one year.\n- Scar revision surgery within one year in the affected areas.\n- Keloids.\n- Active cancer or previous cancer within two years (skin cancers do not apply).\n- Penicillin and Streptomycin allergy."}

Primary endpoints

• {"endpoint_text":"- Change in total patient score of the Danish Patient and Observer Scar Assessment Scale version 3.0.","definition_or_measurement_approach":"Measured as change in the total patient score using the Danish Patient and Observer Scar Assessment Scale v3.0."}

Secondary endpoints

• {"endpoint_text":"- Change in total observer score of the Danish Patient and Observer Scar Assessment Scale version 3.0.","definition_or_measurement_approach":"Measured as change in the total observer score using the Danish Patient and Observer Scar Assessment Scale v3.0."}
• {"endpoint_text":"- Scar volume and microstructure measured by three-dimensional photography, measured in nano cubic meter.","definition_or_measurement_approach":"Measured by three-dimensional photography; units specified as nano cubic meter."}
• {"endpoint_text":"- Scar elevation index / scar thickness by ultrasound video sequencing, measured as a ratio and in milli meter.","definition_or_measurement_approach":"Measured by ultrasound video sequencing; reported as a ratio and in millimetres."}
• {"endpoint_text":"- Changes in collagen fiber arrangement.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Up- and/or downregulation of biomarkers from punch biopsies.","definition_or_measurement_approach":"Measured via biomarker analysis from punch biopsy samples (details not specified)."}
• {"endpoint_text":"- Development of de novo HLA.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Histologic assessment of the presence of donor stem cells / DNA.","definition_or_measurement_approach":"Histologic and DNA assessment of biopsy tissue to identify presence of donor stem cells/DNA."}
• {"endpoint_text":"- Safety assessment by documenting any adverse events or suspected unexpected serious adverse reactions at every follow-up.","definition_or_measurement_approach":"Safety monitored by documentation of adverse events and SUSARs at each follow-up visit."}

Methods

• Document titled 'Recruitment Material Facebook' present (indicates use of Facebook for recruitment).
• Document titled 'Patient Recruitment' present (details not specified).
• Patient handout / recruitment materials available (documents titled 'Patient Handout' and 'Deltagerinformation').

Denmark

Earliest CTIS Part Ii Submission Date

21-03-2025

Latest Decision Or Authorization Date

17-04-2026

Processing Time Days

392

Number Of Sites

1

Number Of Participants

39

Primary sponsor

Full Name

Copenhagen University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}