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

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ClinicalTrials.gov Identifier: NCT04925323
Recruitment Status : Recruiting
First Posted : June 14, 2021
Last Update Posted : June 14, 2021
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Plastic Surgeries Biological: BLOOD SAMPLES Biological: surgical tissue samples Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: VALIDATION OF A GMP-COMPLIANT BIOPRINTING PROCESS FOR MANUFACTURING A DERMO-EPIDERMAL AUTOLOGOUS SKIN SUBSTITUTE FOR FURTHER THERAPEUTIC USE
Actual Study Start Date : January 12, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : October 2023

Arm Intervention/treatment
Experimental: a plastic or repair surgery indication generating surgical waste Biological: BLOOD SAMPLES
BLOOD SAMPLES

Biological: surgical tissue samples
unused surgical tissue removed during plastic surgeries




Primary Outcome Measures :
  1. bioprinted dermo epidermal substitute sterility assessment [ Time Frame: 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.

  2. Population Doubling Rate of keratinocytes [ Time Frame: 24 MONTHS ]
  3. Population Doubling Rate of fibroblasts [ Time Frame: 24MONTHS ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04925323


Contacts
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Contact: Dominique CASANOVA 04 91 35 38 55 dominique.casanova@ap-hm.fr
Contact: baptiste BERTRAND 04.91.35.38.55 baptiste.bertrand@ap-hm.fr

Locations
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France
assistance publique hôpitaux de Marseille Recruiting
Marseille, France
Contact: dominique casanova       dominique.casanova@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: jean-olivier ARNAUD AP HM
Principal Investigator: Dominique CASANOVA AP HM
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT04925323    
Other Study ID Numbers: 2020-33
2020-A01599-30 ( Other Identifier: IDRCB )
First Posted: June 14, 2021    Key Record Dates
Last Update Posted: June 14, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No