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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39107

Enrollment

Registered

2013-03-20

Start date

2014-06-23

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cheloid keloid keloidal scar

Interventions

140 ml of peripheral blood will be withdrawn via standard procedures used in venapuncture. This is not part of the medical treatment for the patient and therefore is extra for this study. This blood

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)