Bone Marrow Derived Adult Stem Cells for Acute Anterior Myocardial Infarction (REGEN-AMI)
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ClinicalTrials.gov Identifier: NCT00765453 |
Recruitment Status :
Completed
First Posted : October 3, 2008
Last Update Posted : March 2, 2020
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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 it is safe and 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 cardiac MRI (or cardiac CT), echocardiography and left ventriculography.
- To demonstrate the effect of autologous bone marrow derived stem cells in addition to standard care leads to improvement in cardiac function compared to patients saline(placebo) and standard care.
Condition or disease | Intervention/treatment | Phase |
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Acute Myocardial Infarction | Other: Bone marrow derived progenitor cells or placebo infusion Other: Placebo infusion | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, 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 |
Study Start Date : | March 2008 |
Actual Primary Completion Date : | March 2014 |
Actual Study Completion Date : | March 2018 |

Arm | Intervention/treatment |
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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
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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
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Other: Placebo infusion
Placebo infusion |
- Longitudinal change in left ventricular function (ejection fraction) [ Time Frame: 1 year ]
- Longitudinal change in left ventricular function (ejection fraction), change in left ventricular end systolic volume, and change in infarct size [ Time Frame: 3 months ]
- Longitudinal change in left ventricular function as measured by LV angiography [ Time Frame: 6 months ]
- Longitudinal change in left ventricular function assessed by echocardiography. [ Time Frame: 6 months ]
- Change in left ventricular end systolic volume and change in infarct size. [ Time Frame: 12 months ]
- Longitudinal change in left ventricular function assessed by echocardiography. [ Time Frame: 12 months ]
- MACE [ Time Frame: 12 months ]
- Change in Quality of life [ Time Frame: 6 and 12 months ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 in the LAD territory
- Age 18 - 80 Years (primary angioplasty confers an adverse prognosis in those over the age of 80 years)
- Written informed consent in the recruiting centres native language
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 as a planned procedure (these vessels can be treated at baseline)
- Arteriovenous malformations or aneurysms
- Active infection, or fever or diarrhoea within last 4 weeks
- Chronic inflammatory disease
- Known 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00765453
Denmark | |
Rigshopitalet, Unversity of Copenhagen | |
Copenhagen, Denmark | |
Switzerland | |
Centre Hospitalier Universitaire Vaudois | |
Lausanne, Switzerland | |
United Kingdom | |
London Chest Hospital, Barts and The London NHS Trust | |
Bethnal Green, London, United Kingdom, E2 9JX | |
The Heart Hosptial, UCLH Foundation Trust | |
London, United Kingdom | |
The Royal Free Hospital, Royal Free London Foundation Trust | |
London, United Kingdom |
Principal Investigator: | Anthony Mathur, FRCP FESC Ph | Barts and the London NHS Trust |
Responsible Party: | Anthony Mathur, Professor, Barts & The London NHS Trust |
ClinicalTrials.gov Identifier: | NCT00765453 |
Other Study ID Numbers: |
07/Q0603/76 2007-002-144 |
First Posted: | October 3, 2008 Key Record Dates |
Last Update Posted: | March 2, 2020 |
Last Verified: | February 2020 |
Heart attack Anterior Myocardial infarction (MI) adult stem cells bone marrow progenitor cells |
bone marrow stem cells autologous left ventricular function intracoronary injection |
Myocardial Infarction Anterior Wall Myocardial Infarction Infarction Ischemia Pathologic Processes |
Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |