Overview
Sponsor-declared trial summary
Hypertrophic scarring.
The objective is to investigate the potential therapeutic efficacy of allogeneic adipose-derived stem cells and autologous stromal vascular fraction on scar quality as compared to placebo.
Key facts
- Sponsor
- Copenhagen University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Decision date (initial)
- 2025-04-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
The objective is to investigate the potential therapeutic efficacy of allogeneic adipose-derived stem cells and autologous stromal vascular fraction on scar quality as compared to placebo.
Secondary objectives 7
- Safety assessment.
- Changes in scar volume and microstructure after six and 12 months.
- Changes in scar elevation index after six and 12 months.
- Change in collagen arrangement and architecture after 12 months.
- Changes in biomarker expression of punch biopsies after 12 months.
- Immune response to allogeneic stem cells after 12 months.
- Presence of stem cells in the scar tissue after 12 months.
Conditions and MedDRA coding
Hypertrophic scarring.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Adults ≥ 18 years of age
- Hypertrophic scars (age of scar > 2 years) after burn injuries on the front trunk or extremities.
- 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.
- BMI > 22 and enough abdominal fat for a minor liposuction.
- Ability to understand information about the project.
Exclusion criteria 9
- Significant comorbidities or lack of cognitive abilities to follow instructions.
- Not being able to participate due to language or other personal issues.
- Contraindications for abdominal liposuction.
- Pregnancy or breastfeeding
- Current or previous steroid therapy (systemic or local) within one year.
- Scar revision surgery within one year in the affected areas.
- Keloids.
- Active cancer or previous cancer within two years (skin cancers do not apply).
- Penicillin and Streptomycin allergy.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change in total patient score of the Danish Patient and Observer Scar Assessment Scale version 3.0.
Secondary endpoints 8
- Change in total observer score of the Danish Patient and Observer Scar Assessment Scale version 3.0.
- Scar volume and microstructure measured by three-dimensional photography, measured in nano cubic meter.
- Scar elevation index / scar thickness by ultrasound video sequencing, measured as a ratio and in milli meter.
- Changes in collagen fiber arrangement.
- Up- and/or downregulation of biomarkers from punch biopsies.
- Development of de novo HLA.
- Histologic assessment of the presence of donor stem cells / DNA.
- Safety assessment by documenting any adverse events or suspected unexpected serious adverse reactions at every follow-up.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Culture expanded Adipose Derived Regenerative Cells, ADRC001
PRD10512270 · Product
- Active substance
- ADRC001
- Other product name
- ADRC001
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRADERMAL INJECTION
- Authorisation status
- Not Authorised
- MA holder
- OUPHET
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
CryoStor CS10 + Physiologic solution, e.g., Ringers Lactate
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Copenhagen University Hospital
- Sponsor organisation
- Copenhagen University Hospital
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Copenhagen University Hospital
- Contact name
- Laura Hansen
Public contact point
- Organisation
- Copenhagen University Hospital
- Contact name
- Laura Hansen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 39 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Gen O-SAS | 1 |
| Protocol (for publication) | Gen P-SAS | 1 |
| Protocol (for publication) | Patient Handout | 1 |
| Protocol (for publication) | Protocol 2024-519160-41-00 | 3 |
| Recruitment arrangements (for publication) | Patient Recruitment | 2 |
| Recruitment arrangements (for publication) | Recruitment Material Facebook | 3 |
| Subject information and informed consent form (for publication) | Deltagerinformation | 5 |
| Subject information and informed consent form (for publication) | Fr du beslutter dig | 2 |
| Subject information and informed consent form (for publication) | Samtykkeerklring | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC | 1 |
| Synopsis of the protocol (for publication) | Protocol Synopsis | 2 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-20 | Denmark | Acceptable 2025-04-11
|
2025-04-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-27 | Denmark | Acceptable 2025-08-19
|
2025-08-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-26 | Denmark | Acceptable 2026-04-17
|
2026-04-17 |