- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02439047
Preliminary Study to the Manufacturing of a Non-stick Membrane for Surgery Using Patient's Own Cells (MESO-PATCH) (MESO-PATCH)
Non-stick Patch of Mesothelial Cells in a Hydrogel Matrix : Exploratory Analysis Assessing the Morphotype and Mesothelial Phenotype After Culture From 2 Cells Sources of Human Origin.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- Patient information and collection of a signed informed consent
- Clinical data collection: surgery date, age, weight, height, medical and surgical history
- Prospective collection of peritoneal and adipose biopsies of patients during their surgery at the Oscar Lambret Center (Dr L. BRESSON)
- Transportation of the samples to the 1008 INSERM Unit.
- Isolation of cells from the samples : mesothelial cells from the peritoneum and adipose stem cells from adipose tissue
- Cell culture and expansion of mesothelial cells; and cell culture and differentiation of adipose stem cells
- Identification by the morphotype and phenotype of mesothelial cells
- Comparison of the results according to the cell source, peritoneum or adipocyte, to the purity of cells and to the efficacy of the expansion
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lille, France, 59020
- Centre Oscar Lambret
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged more than 18 years old,
- Planned surgery For peritoneal samples : abdominal surgery (laparotomy or coelioscopy) For adipose tissue samples : breast reconstructive surgery (lipomodelage)
- Informed and signed consent
Exclusion Criteria:
- Pregnant or breastfeeding woman
- Patient under guardianship or tutorship
- For peritoneal samples : previous abdomino-pelvic radiotherapy or abdominal surgery ; peritoneal carcinosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Biological samples collection
-Peritoneal samples : will be collected during abdominal surgery A biopsy from 1 to 2 cm2 will be performed in healthy peritoneum -Adipose tissue samples : will be collected during surgery for breast reconstruction |
-Peritoneal samples : will be collected during abdominal surgery A biopsy from 1 to 2 cm2 will be performed in healthy peritoneum - Adipose tissue samples : will be collected during surgery for breast reconstruction |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Morphotype/Phenotype expression
Time Frame: 1 year
|
Mesothelial morphotype and phenotype expression of the 2 types of cells after culture
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lucie BRESSON, MD, Centre Oscar Lambret
- Study Director: Feng Chai, MD, INSERM U1008
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MESO-PATCH-1408
- 2014-A01866-41 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.