Preliminary Study to the Manufacturing of a Non-stick Mem... | NCT02439047

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

NCT02439047

Sponsor

Centre Oscar Lambret

Status

Terminated

Last Update Posted

Mar 16, 2026Actual

Enrollment

6Actual

Phase

Not Applicable

Conditions

Cancer

Interventions

Biological samples collection

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2014-A01866-41	Other Identifier	ANSM

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

difficulty of carrying out the analysis and low recruitment

Expanded Access Info

Start Date

Jun 2015Actual

Primary Completion Date

Nov 2015Actual

Completion Date

Nov 2016Actual

First Submitted Date

Apr 23, 2015

First Submission Date that Met QC Criteria

May 5, 2015

First Posted Date

May 8, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2026

Last Update Posted Date

Mar 16, 2026Actual

Name	Class
Institut National de la Santé Et de la Recherche Médicale, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Biological samples collection	Experimental	-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	Procedure: Biological samples collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biological samples collection	Procedure	-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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Morphotype/Phenotype expression	Mesothelial morphotype and phenotype expression of the 2 types of cells after culture	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lucie BRESSON, MD	Centre Oscar Lambret	Principal Investigator
Feng Chai, MD	INSERM U1008	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Oscar Lambret		Lille		59020	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided