Development of an in vitro keloid scar model for identifying and testing new anti-scar therapies.

Completed

Conditions: cheloid
keloid
keloidal scar
10040899

Registration Number: NL-OMON39107

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

For keloid patients:
- history of keloid formation: presence of at least 1 major keloid (>0.5cm)at least 6 months old, diagnosed as such by plastic surgeon specialized in scarring
- 18 years or older and capable of giving informed consent;For healthy controls:
- previously undergone surgery of the trunk region (thorax, abdomen) resulting in a
normal scar at least 5cm in length
- normal scar should be at least 6 months old
- no abnormal scarring in medical history
- 18 years or older and capable of giving informed consent

Exclusion Criteria

- systemic illness
- chronic use of systemic medication (e.g. corticosteroids, anti-inflammatory drugs such as aspirin)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Development of a human, in vitro, immunocompetent full-thickness<br /><br>tissue-engineered keloid scar model and identification of robust and relevant<br /><br>parameters to assess scar formation in vitro<br /><br><br /><br>Keloid scar parameters:<br /><br>• epidermal and dermal thickness (histological analysis)<br /><br>• contraction<br /><br>• myofibroblast a-SMA expression (immunohistochemical staining)<br /><br>• wound healing mediator expression (ELISA)<br /><br><br /><br>Immune cell parameters:<br /><br>• changes in monocyte and T cell phenotype after co-culture with keloid tissue<br /><br>compared to normal tissue. Flow cytometric analysis to identify transition into<br /><br>e.g.: macrophages, Th1, Th2, fibrocytes, endothelial cells etc.)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Validation of the in vitro keloid scar model with the aid of parameters<br /><br>identified above<br /><br>• Positive controls: therapeutics currently used for treating scars (e.g. 5FU,<br /><br>corticosteroids). Normalization (partial) of scar parameters is expected.<br /><br>• Negative controls: therapeutic known to be ineffective in scar treatment<br /><br>(e.g. vitamin D3). No normalization effect of scar parameters is expected.</p><br>