A DERMO-EPIDERMAL AUTOLOGOUS SKIN SUBSTITUTE FOR FURTHER THERAPEUTIC USE

Not Applicable

• Conditions: Plastic Surgeries
• Interventions: Biological: BLOOD SAMPLES; Biological: surgical tissue samples

• Registration Number: NCT04925323
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2021-01-12
• Study First Submitted: 2021-03-29
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-07
• Last Update Submitted: 2021-06-07
• Study First Posted: 2021-06-14
• Last Update Posted: 2021-06-14
• Primary Completion: 2023-04
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
a plastic or repair surgery indication generating surgical waste	surgical tissue samples	-
a plastic or repair surgery indication generating surgical waste	BLOOD SAMPLES	-

Primary Outcome Measures

Name	Time	Method
bioprinted dermo epidermal substitute sterility assessment	24 MONTHS	Culture media from dermo-epidermal bioprinted substitutes were sampled in Bactec culture bottles (Peds Plus Aerobic/F and Plus Anaerobic/F culture vials, containing each 40 mL of medium). The Bactec method (Becton Dickinson, Sparks, MD, USA) uses a computer-controlled incubation/detection system. The media used contained proprietary factors designed to inactivate a wide variety of antibacterial and antifungal agents. Bactec culture bottles were incubated at 37 °C for a total of 10 days, and automated readings were taken every 10 min. Detection of organisms resulted in an audible alarm and automatic recording of time to detection.
Population Doubling Rate of keratinocytes	24 MONTHS
Population Doubling Rate of fibroblasts	24MONTHS

Trial Locations

Locations (1)

assistance publique hôpitaux de Marseille; 🇫🇷 Marseille, France