Pened Chest Surgery for Programmes Coronary BypassMESSAGENCT00836732
Mesenchymal Stem Cells: Alterations in Genome
A study testing harvest of a small bone marrow sample in people with Pened Chest Surgery for Programmes Coronary Bypass, run by Nantes University Hospital at 1 site in France.
Trial summary
The aim is to study small genetic alterations induced by cell culture in human mesenchymal stem cells in GMP condition. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pened Chest Surgery for Programmes Coronary Bypass
- What is being tested?
- harvest of a small bone marrow sample
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2008to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 old
- age < 75 old
- opened chest surgery for programmed coronary bypass
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MESenchymal Stem Cells: Alterations in GEnome
The aim is to study small genetic alterations induced by cell culture in human mesenchymal stem cells in GMP condition.
- Being tested
- harvest of a small bone marrow sample
- Keywords
- celle therapy, cell culture, mesenchymal stem cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
harvest of a small bone marrow sampleProcedure or surgery
harvest of a small bone marrow sample during open chest surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of small genetic alteration in mesenchymal stem cells
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startNov 2008
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pened Chest Surgery for Programmes Coronary BypassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Lemarchand, MD, Principal investigator, Nantes UH - institut du thorax
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836732
- Sponsor's protocol ID
- BRD 08/9-S
- Acronym
- MESSAGE
- Status last verified
- Sep 2013
- First submitted
- 3 Feb 2009
- Last updated
- 30 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MESenchymal Stem Cells: Alterations in GEnome
- ClinicalTrials.gov ID
- NCT00836732
- Acronym / sponsor ID
- MESSAGE / BRD 08/9-S
- Keywords
- celle therapy, cell culture, mesenchymal stem cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim is to study small genetic alterations induced by cell culture in human mesenchymal stem cells in GMP condition.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18 old
- age < 75 old
- opened chest surgery for programmed coronary bypass
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| harvest of a small bone marrow sampleharvest of a small bone marrow sample during open chest surgery | Procedure or surgery | – |
Primary outcome
Presence of small genetic alteration in mesenchymal stem cells
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Lemarchand, MD principal investigator
Nantes UH - institut du thorax
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing harvest of a small bone marrow sample in people with Pened Chest Surgery for Programmes Coronary Bypass, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of small genetic alteration in mesenchymal stem cells (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2013.