Preliminary Study to the Manufacturing of a Non-stick Membrane for Surgery Using Patient's Own Cells (MESO-PATCH)

Not Applicable

Terminated

• Conditions: Cancer
• Interventions: Procedure: Biological samples collection

• Registration Number: NCT02439047
• Lead Sponsor: Centre Oscar Lambret

Brief Summary

The objective of this study, which will be realised in vitro on human samples, is to test 2 cell sources isolated from peritoneum for adult mesothelial cells (peritoneal samples) and from adipose tissue for the adipose stem cells (adipose tissue samples). The latter will be differentiated towards the mesothelial phenotype and morphotype. The 2 routes will be compared and the most satisfactory one will be chosen to make a non-stick patch.

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 Timeline

• Study First Submitted: 2015-04-23
• Study First Submitted QC: 2015-05-05
• Study First Posted: 2015-05-08
• Study Start: 2015-06
• Primary Completion: 2015-11
• Study Completion: 2016-11
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-08
• Last Update Posted: 2018-11-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biological samples collection	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

Primary Outcome Measures

Name	Time	Method
Morphotype/Phenotype expression	1 year	Mesothelial morphotype and phenotype expression of the 2 types of cells after culture

Trial Locations

Locations (1)

Centre Oscar Lambret; 🇫🇷 Lille, France