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

Cancer Clinical Trial

— MESO-PATCH  

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02439047
• Other study ID #: MESO-PATCH-1408
• Status: Terminated
• Phase: N/A
• Start date: June 2015
• Est. completion date: November 2016

Study information

• Verified date: November 2018
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: November 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille

Sponsors (2)

Lead Sponsor	Collaborator
Centre Oscar Lambret	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphotype/Phenotype expression	Mesothelial morphotype and phenotype expression of the 2 types of cells after culture	1 year