A DERMO-EPIDERMAL AUTOLOGOUS SKIN SUBSTITUTE FOR FURTHER THERAPEUTIC USE (BIOPSKIN)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04925323|
Recruitment Status : Recruiting
First Posted : June 14, 2021
Last Update Posted : June 14, 2021
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|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|
|Experimental: a plastic or repair surgery indication generating surgical waste||
Biological: BLOOD SAMPLES
Biological: surgical tissue samples
unused surgical tissue removed during plastic surgeries
- 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.
- Population Doubling Rate of keratinocytes [ Time Frame: 24 MONTHS ]
- Population Doubling Rate of fibroblasts [ Time Frame: 24MONTHS ]
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
|Contact: Dominique CASANOVA||04 91 35 38 email@example.com|
|Contact: baptiste BERTRANDfirstname.lastname@example.org|
|assistance publique hôpitaux de Marseille||Recruiting|
|Contact: dominique casanova email@example.com|
|Study Director:||jean-olivier ARNAUD||AP HM|
|Principal Investigator:||Dominique CASANOVA||AP HM|