Bone Marrow Derived Adult Stem Cells for Acute Anterior Myocardial Infarction

NCT ID: NCT00765453

Last Updated: 2020-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2018-03-31

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.

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Bone marrow derived progenitor cells or placebo infusion

Intervention Type: OTHER

Over-the-wire balloon catheter delivers infusion into coronary vessel using a stop-flow technique

Placebo

Placebo infusion

Group Type: PLACEBO_COMPARATOR

Placebo infusion

Intervention Type: OTHER

Placebo infusion

Interventions

Bone marrow derived progenitor cells or placebo infusion

Over-the-wire balloon catheter delivers infusion into coronary vessel using a stop-flow technique

Intervention Type: OTHER

Placebo infusion

Placebo infusion

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College, London

OTHER

Sponsor Role: collaborator

Queen Mary University of London

OTHER

Sponsor Role: collaborator

Barts & The London NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Anthony Mathur

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anthony Mathur, FRCP FESC Ph

Role: PRINCIPAL_INVESTIGATOR

Barts and the London NHS Trust

Locations

Rigshopitalet, Unversity of Copenhagen

Copenhagen, , Denmark

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

London Chest Hospital, Barts and The London NHS Trust

Bethnal Green, London, United Kingdom

The Heart Hosptial, UCLH Foundation Trust

London, , United Kingdom

The Royal Free Hospital, Royal Free London Foundation Trust

London, , United Kingdom

Countries

Denmark; Switzerland; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 26405233 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24549163 (View on PubMed)

Other Identifiers

2007-002-144

Identifier Type: -

Identifier Source: secondary_id

07/Q0603/76

Identifier Type: -

Identifier Source: org_study_id