Myocardial InfarctPhase 2NCT00560742
Efficacy Study of Intramuscular or Intracoronary Injection of Autologous Bone Marrow Cells to Treat Scarred Myocardium
A Phase 2 study testing Intramuscular administration of bone marrow cells and Intracoronary administration of bone marrow cells in people with Myocardial Infarct and Bone Marrow Cells, run by University Hospitals, Leicester at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine whether the administration of patient's own bone marrow cells into scar areas of the heart, can improve the contractile function of these areas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarct, Bone Marrow Cells
- What is being tested?
- Intramuscular administration of bone marrow cells and Intracoronary administration of bone marrow cells
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2002to Jul 2007
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing elective CABG
- chronic irreversible myocardial scar
- coronary vessel supplying the scar must be amenable to bypass grafting
Who cannot join
- significant valvular heart diseases
- major organ failures, eg. heart, liver, renal etc
- pre-existing bone marrow conditions
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Leicester
Leicester, Leicestershire, LE3 9QP
About this study
Official title: Efficacy of the Mode of Delivery of Autologous Bone Marrow Cells Into Heart Scar Muscle for the Recovery of Contractile Function
The purpose of this study is to determine whether the administration of patient's own bone marrow cells into scar areas of the heart, can improve the contractile function of these areas.
- Conditions
- Myocardial Infarct, Bone Marrow Cells
- Being tested
- Control, Intramuscular administration of bone marrow cells, Intracoronary administration of bone marrow cells
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlProcedure or surgery
Coronary artery bypass grafting without bone marrow cells injection
Intramuscular administration of bone marrow cellsProcedure or surgery
Coronary artery bypass grafting, and intramuscular administration of bone marrow cells into myocardial scar
Intracoronary administration of bone marrow cellsProcedure or surgery
Coronary artery bypass grafting, and intracoronary administration of bone marrow cells into myocardial scar
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Procedure: Control |
| Intramuscular | Experimental | Not described Receives: Procedure: Intramuscular administration of bone marrow cells |
| Intracoronary | Experimental | Not described Receives: Procedure: Intracoronary administration of bone marrow cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contractile function of treated scar areas
Measured: 6 months
Secondary outcomes (1)
Global left ventricular functions
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startNov 2002
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Investigators
- Manuel Galiñanes, MD PhD FRCS, Principal investigator, University Hospitals, Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560742
- Sponsor's protocol ID
- PG04050
- Other IDs
- UHL ref: 7638
- Status last verified
- Nov 2007
- First submitted
- 16 Nov 2007
- Last updated
- 20 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Mode of Delivery of Autologous Bone Marrow Cells Into Heart Scar Muscle for the Recovery of Contractile Function
- ClinicalTrials.gov ID
- NCT00560742
- Acronym / sponsor ID
- PG04050
- Conditions
- Myocardial Infarct, Bone Marrow Cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- Nov 2002
- Study completion
- Jul 2007 (actual)
- First posted
- 20 Nov 2007 (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 purpose of this study is to determine whether the administration of patient's own bone marrow cells into scar areas of the heart, can improve the contractile function of these areas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Control |
| Intramuscular | Experimental | Procedure: Intramuscular administration of bone marrow cells |
| Intracoronary | Experimental | Procedure: Intracoronary administration of bone marrow cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing elective CABG
- chronic irreversible myocardial scar
- coronary vessel supplying the scar must be amenable to bypass grafting
Key exclusion criteria (3 listed)
- significant valvular heart diseases
- major organ failures, eg. heart, liver, renal etc
- pre-existing bone marrow conditions
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 |
|---|---|---|
| ControlCoronary artery bypass grafting without bone marrow cells injection | Procedure or surgery | Control |
| Intramuscular administration of bone marrow cellsCoronary artery bypass grafting, and intramuscular administration of bone marrow cells into myocardial scar | Procedure or surgery | Intramuscular |
| Intracoronary administration of bone marrow cellsCoronary artery bypass grafting, and intracoronary administration of bone marrow cells into myocardial scar | Procedure or surgery | Intracoronary |
Primary outcome
Contractile function of treated scar areas
Time frame: 6 months
1 secondary outcome
Global left ventricular functions
Time frame: 6 months
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 20 Nov 2007.
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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.
Manuel Galiñanes, MD PhD FRCS principal investigator
University Hospitals, Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intramuscular administration of bone marrow cells and Intracoronary administration of bone marrow cells in people with Myocardial Infarct and Bone Marrow Cells, run by University Hospitals, Leicester at 1 site in United Kingdom.
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 3 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 20 Nov 2007. 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 United Kingdom. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contractile function of treated scar areas (time frame: 6 months). 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 20 Nov 2007.