Bone Marrow Derived Adult Stem Cells for Acute Anterior Myocardial Infarction (REGEN-AMI)
Primary Purpose
Acute Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Bone marrow derived progenitor cells or placebo infusion
Placebo infusion
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Heart attack, Anterior Myocardial infarction (MI), adult stem cells, bone marrow progenitor cells, bone marrow stem cells, autologous, left ventricular function, intracoronary injection
Eligibility 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 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
Sites / Locations
- Rigshopitalet, Unversity of Copenhagen
- Centre Hospitalier Universitaire Vaudois
- London Chest Hospital, Barts and The London NHS Trust
- The Heart Hosptial, UCLH Foundation Trust
- The Royal Free Hospital, Royal Free London Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intracoronary
Placebo
Arm Description
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
Placebo infusion
Outcomes
Primary Outcome Measures
Longitudinal change in left ventricular function (ejection fraction)
Secondary Outcome Measures
Longitudinal change in left ventricular function (ejection fraction), change in left ventricular end systolic volume, and change in infarct size
Longitudinal change in left ventricular function as measured by LV angiography
Longitudinal change in left ventricular function assessed by echocardiography.
Change in left ventricular end systolic volume and change in infarct size.
Longitudinal change in left ventricular function assessed by echocardiography.
MACE
Change in Quality of life
Full Information
NCT ID
NCT00765453
First Posted
October 2, 2008
Last Updated
February 27, 2020
Sponsor
Barts & The London NHS Trust
Collaborators
University College, London, Queen Mary University of London
1. Study Identification
Unique Protocol Identification Number
NCT00765453
Brief Title
Bone Marrow Derived Adult Stem Cells for Acute Anterior Myocardial Infarction
Acronym
REGEN-AMI
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 Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barts & The London NHS Trust
Collaborators
University College, London, Queen Mary University of London
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Heart attack, Anterior Myocardial infarction (MI), adult stem cells, bone marrow progenitor cells, bone marrow stem cells, autologous, left ventricular function, intracoronary injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intracoronary
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo infusion
Intervention Type
Other
Intervention Name(s)
Bone marrow derived progenitor cells or placebo infusion
Intervention Description
Over-the-wire balloon catheter delivers infusion into coronary vessel using a stop-flow technique
Intervention Type
Other
Intervention Name(s)
Placebo infusion
Intervention Description
Placebo infusion
Primary Outcome Measure Information:
Title
Longitudinal change in left ventricular function (ejection fraction)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Longitudinal change in left ventricular function (ejection fraction), change in left ventricular end systolic volume, and change in infarct size
Time Frame
3 months
Title
Longitudinal change in left ventricular function as measured by LV angiography
Time Frame
6 months
Title
Longitudinal change in left ventricular function assessed by echocardiography.
Time Frame
6 months
Title
Change in left ventricular end systolic volume and change in infarct size.
Time Frame
12 months
Title
Longitudinal change in left ventricular function assessed by echocardiography.
Time Frame
12 months
Title
MACE
Time Frame
12 months
Title
Change in Quality of life
Time Frame
6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Mathur, FRCP FESC Ph
Organizational Affiliation
Barts and the London NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshopitalet, Unversity of Copenhagen
City
Copenhagen
Country
Denmark
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
Country
Switzerland
Facility Name
London Chest Hospital, Barts and The London NHS Trust
City
Bethnal Green
State/Province
London
ZIP/Postal Code
E2 9JX
Country
United Kingdom
Facility Name
The Heart Hosptial, UCLH Foundation Trust
City
London
Country
United Kingdom
Facility Name
The Royal Free Hospital, Royal Free London Foundation Trust
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
26405233
Citation
Choudry F, Hamshere S, Saunders N, Veerapen J, Bavnbek K, Knight C, Pellerin D, Locca D, Westwood M, Rakhit R, Crake T, Kastrup J, Parmar M, Agrawal S, Jones D, Martin J, Mathur A. A randomized double-blind control study of early intra-coronary autologous bone marrow cell infusion in acute myocardial infarction: the REGENERATE-AMI clinical trialdagger. Eur Heart J. 2016 Jan 14;37(3):256-63. doi: 10.1093/eurheartj/ehv493. Epub 2015 Sep 23.
Results Reference
derived
PubMed Identifier
24549163
Citation
Hamshere S, Choudhury T, Jones DA, Locca D, Mills P, Rothman M, Knight C, Parmar M, Agrawal S, Martin J, Mathur A. A randomised double-blind control study of early intracoronary autologous bone marrow cell infusion in acute myocardial infarction (REGENERATE-AMI). BMJ Open. 2014 Feb 18;4(2):e004258. doi: 10.1136/bmjopen-2013-004258.
Results Reference
derived
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Bone Marrow Derived Adult Stem Cells for Acute Anterior Myocardial Infarction
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