Bone Marrow Derived Adult Stem Cells for Acute Anterior Myocardial Infarction (REGEN-AMI)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Barts & The London NHS Trust.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Barts & The London NHS Trust
Collaborators:
University College, London
Queen Mary University of London
Information provided by:
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT00765453
First received: October 2, 2008
Last updated: February 21, 2011
Last verified: February 2011
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Purpose
Study hypothesis :
The purpose of this study is to determine whether Intracoronary infusion of autologous bone marrow derived progenitor cells to patients undergoing primary angioplasty for acute anterior myocardial infarction will lead to an improvement in cardiac function greater than that seen by placebo alone.
Aims
- To demonstrate that intracoronary delivery of autologous bone marrow progenitor cells is safe.
- To demonstrate that it is feasible to deliver autologous bone marrow derived stem cells within hours of the primary angioplasty procedure
- To demonstrate the effects of autologous bone marrow derived stem cells on cardiac function using tissue Doppler echocardiography, cardiac MRI and left ventriculography.
- To show a difference in cardiac function between patients treated with cells and saline(placebo).
| Condition | Intervention | Phase |
|---|---|---|
|
Acute AMI |
Other: Bone marrow derived progenitor cells or placebo infusion Other: Placebo infusion |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Randomised Controlled Clinical Trial of the Use of Autologous Bone Marrow Derived Progenitor Cells to Salvage Myocardium in Patients With Acute Anterior Myocardial Infarction |
Resource links provided by NLM:
Further study details as provided by Barts & The London NHS Trust:
Primary Outcome Measures:
- Longitudinal change in left ventricular function (ejection fraction) as measured by cardiac MRI. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Longitudinal change in left ventricular function (ejection fraction) Reduction of left ventricular end systolic volume, Change in regional wall motion in infarct area and Change in infarct mass as measured by cardiac MRI [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Change in global ejection fraction as measured by LV angiography and improvement of myocardial contractility, assessed by contrast echocardiogram(wall motion score index). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Major adverse cardiac events (MACE), Death (independent of cause and sudden death), myocardial infarction (Q-wave and Non-Q-wave), coronary revascularization [coronary bypass or PCI). [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- LV function as measured by cardiac MRI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- MACE [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 102 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intracoronary
Patients will be randomised in a 1:1 ratio to receive intracoronary injections of bone marrow derived stem/progenitor cells or placebo infusion through a percutaneous route
|
Other: Bone marrow derived progenitor cells or placebo infusion
Over-the-wire balloon catheter delivers infusion into coronary vessel using a stop-flow technique
|
|
Placebo Comparator: Placebo
Placebo infusion
|
Other: Placebo infusion
Placebo infusion
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients presenting to the Heart Attack Centre with acute anterior myocardial infarction (ST elevation in at least 2 contiguous anterior leads ≥ 0.2 mV) and treated with acute PCI with stent implantation within 24 hours after symptom onset
- Acute PCI / stent implantation has been successful (residual stenosis visually < 30% and TIMI flow ≥ 2).
- At the time of inclusion patient no longer requires i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump)
- Significant regional wall motion abnormality in LV angiogram at the time of acute PCI
- Age 18 - 80 Years (primary angioplasty confers an adverse prognosis in those over the age of 80 years)
- Written informed consent
Exclusion Criteria:
- Regional wall motion abnormality outside the area involved in the index acute myocardial infarction
- Need to revascularise additional vessels, outside the infarct artery
- Arteriovenous malformations or aneurysms
- Active infection, or fever or diarrhoea within last 4 weeks
- Chronic inflammatory disease
- HIV infection or active hepatitis
- Neoplastic disease without documented remission within the past 5 years
- Cerebrovascular insult within 3 months
- Impaired renal function (creatinine > 200mmol) at the time of cell therapy
- Significant liver disease (GOT > 2x upper limit) or spontaneous INR > 1,5)
- Anemia (hemoglobin < 8.5 mg/dl)
- Platelet count < 100.000/µl
- Hypersplenism
- Known allergy or intolerance to clopidogrel, heparin or abciximab
- History of bleeding disorder
- Gastrointestinal bleeding within 3 months
- Major surgical procedure or trauma within 2 months
- Uncontrolled hypertension
- Pregnancy
- Mental retardation leading to inability to obtain informed consent
- Previously performed stem / progenitor cell therapy
- Participation in another clinical trial within the last 30 days
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765453
Contacts
| Contact: Anthony Mathur, FRCP FESC Ph | (44) 2089832216 | regenerate@bartsandthelondon.nhs.uk |
Locations
| United Kingdom | |
| London Chest Hospital, Barts and The London NHS Trust | Recruiting |
| Bethnal Green, London, United Kingdom, E2 9JX | |
| Sub-Investigator: Didier Locca, MD | |
| Sub-Investigator: John Martin, MD, PHD | |
| Sub-Investigator: Thomas Burchell, MRCP | |
Sponsors and Collaborators
Barts & The London NHS Trust
University College, London
Queen Mary University of London
Investigators
| Principal Investigator: | Anthony Mathur, FRCP FESC Ph | Barts and the London NHS Trust |
More Information
Additional Information:
No publications provided
| Responsible Party: | Anthony Mathur, Barts & The London NHS Trust |
| ClinicalTrials.gov Identifier: | NCT00765453 History of Changes |
| Other Study ID Numbers: | 07/Q0603/76, 2007-002-144 |
| Study First Received: | October 2, 2008 |
| Last Updated: | February 21, 2011 |
| Health Authority: | United Kingdom: Research Ethics Committee United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Barts & The London NHS Trust:
|
Heart attack Anterior Myocardial infarction (MI) adult stem cells bone marrow progenitor cells |
bone marrow stem cells autologous left ventricular function intracoronary injection |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Anterior Wall Myocardial Infarction Ischemia Pathologic Processes |
Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013