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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
Barts & The London NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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
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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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