A DERMO-EPIDERMAL AUTOLOGOUS SKIN SUBSTITUTE FOR FURTHER THERAPEUTIC USE

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-12

Study Completion Date

2023-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Plastic Surgeries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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a plastic or repair surgery indication generating surgical waste

Group Type EXPERIMENTAL

BLOOD SAMPLES

Intervention Type BIOLOGICAL

BLOOD SAMPLES

surgical tissue samples

Intervention Type BIOLOGICAL

unused surgical tissue removed during plastic surgeries

Interventions

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BLOOD SAMPLES

Intervention Type BIOLOGICAL

surgical tissue samples

unused surgical tissue removed during plastic surgeries

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.