A DERMO-EPIDERMAL AUTOLOGOUS SKIN SUBSTITUTE FOR FURTHER THERAPEUTIC USE (BIOPSKIN)

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Unknown

Conditions: Plastic Surgeries

Treatments: Biological: surgical tissue samples; Biological: BLOOD SAMPLES

Study type: Interventional

Funder types: Other

Identifiers

NCT04925323

2020-A01599-30 (Other Identifier)

2020-33

Details and patient eligibility

About

Innovative technologies in the emerging field of regenerative medicine might allow an improvement in the treatment of deep complex wounds leading to faster and better wound healing. Among them, the bioprinting technology, consisting in "printing human cells and biomaterials" to create a "dermo-epidermal substitute" that mimics an alternative of the physiological skin is the most promising alternative.

Besides improving skin substitutes properties, bioprinting allows to translate the manufacturing process of tissue-engineered products from manual, operator-dependent processes to a reproducible and automated solution. This paves the way to the manufacturing of therapeutic bioprinted products at the point of care, as close as possible from patients.

Full description

In this preclinical in vitro study, the investigators plan to generate GMP-compliant validation batches of "bio-printed dermo-epidermal substitutes" from 25 healthy volunteer patients' unused surgical tissue removed during plastic surgeries.

Volunteer's harvested tissue will allow to extract and then amplify the epidermal keratinocytes and dermal fibroblasts. Successive cultures and bioprinting steps will generate a "bio-printed dermo-epidermal substitute" in 2 or 3 weeks. A blood test may also be performed on the volunteers to characterize the genetic stability during the different stages of the process.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult adult males or females
• Members of a social security scheme.
• No contraindications to general anesthesia
• Relevant to a plastic or repair surgery indication generating surgical waste.

Exclusion criteria

• Pregnant and/or nursing women
• Persons deprived of liberty
• Major under guardianship
• Persons unable to read the backgrounder.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

a plastic or repair surgery indication generating surgical waste

Experimental group

Treatment:

Biological: BLOOD SAMPLES

Biological: surgical tissue samples