Bone Marrow Derived Adult Stem Cells for Acute Anterior Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765453
• Other study ID #: 07/Q0603/76
• Secondary ID: 2007-002-144
• Status: Completed
• Phase: N/A
• Start date: March 2008
• Est. completion date: March 2018

Study information

• Verified date: February 2020
• Source: Barts & The London NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2018
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Anterior Wall Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

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 infusion
Placebo infusion

Locations

Country	Name	City	State
Denmark	Rigshopitalet, Unversity of Copenhagen	Copenhagen
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
United Kingdom	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

Sponsors (3)

Lead Sponsor	Collaborator
Barts & The London NHS Trust	Queen Mary University of London, University College, London

Countries where clinical trial is conducted

Denmark,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Longitudinal change in left ventricular function (ejection fraction)		1 year
Secondary	Longitudinal change in left ventricular function (ejection fraction), change in left ventricular end systolic volume, and change in infarct size		3 months
Secondary	Longitudinal change in left ventricular function as measured by LV angiography		6 months
Secondary	Longitudinal change in left ventricular function assessed by echocardiography.		6 months
Secondary	Change in left ventricular end systolic volume and change in infarct size.		12 months
Secondary	Longitudinal change in left ventricular function assessed by echocardiography.		12 months
Secondary	MACE		12 months
Secondary	Change in Quality of life		6 and 12 months