Mesenchymal Stem Cells: Alterations in Genome (MESSAGE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00836732
First received: February 3, 2009
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

The aim is to study small genetic alterations induced by cell culture in human mesenchymal stem cells in GMP condition.


Condition Intervention
Pened Chest Surgery for Programmes Coronary Bypass
Procedure: harvest of a small bone marrow sample

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: MESenchymal Stem Cells: Alterations in GEnome

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Presence of small genetic alteration in mesenchymal stem cells [ Time Frame: one month ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: November 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: harvest of a small bone marrow sample
    harvest of a small bone marrow sample during open chest surgery
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 18 old
  • age < 75 old
  • opened chest surgery for programmed coronary bypass
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836732

Locations
France
nantes University Hospital
Nantes, France, 44340
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Patricia Lemarchand, MD Nantes UH - institut du thorax
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00836732     History of Changes
Other Study ID Numbers: BRD 08/9-S
Study First Received: February 3, 2009
Last Updated: September 27, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
celle therapy
cell culture
mesenchymal stem cells

ClinicalTrials.gov processed this record on September 30, 2014