NCT00765453

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2008

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

6 years

First QC Date

October 2, 2008

Last Update Submit

February 27, 2020

Conditions

Acute Myocardial Infarction

Keywords

Heart attackAnterior Myocardial infarction (MI)adult stem cellsbone marrow progenitor cellsbone marrow stem cellsautologousleft ventricular functionintracoronary injection

Outcome Measures

Primary Outcomes (1)

  • Longitudinal change in left ventricular function (ejection fraction)

    1 year

Secondary Outcomes (7)

  • Longitudinal change in left ventricular function (ejection fraction), change in left ventricular end systolic volume, and change in infarct size

    3 months

  • Longitudinal change in left ventricular function as measured by LV angiography

    6 months

  • Longitudinal change in left ventricular function assessed by echocardiography.

    6 months

  • Change in left ventricular end systolic volume and change in infarct size.

    12 months

  • Longitudinal change in left ventricular function assessed by echocardiography.

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Intracoronary

EXPERIMENTAL

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

Other: Bone marrow derived progenitor cells or placebo infusion

Placebo

PLACEBO COMPARATOR

Placebo infusion

Other: Placebo infusion

Interventions

Bone marrow derived progenitor cells or placebo infusionOTHER

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

Intracoronary
Placebo infusionOTHER

Placebo infusion

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Rigshopitalet, Unversity of Copenhagen

Copenhagen, Denmark

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Location

London Chest Hospital, Barts and The London NHS Trust

Bethnal Green, London, E2 9JX, United Kingdom

Location

The Heart Hosptial, UCLH Foundation Trust

London, United Kingdom

Location

The Royal Free Hospital, Royal Free London Foundation Trust

London, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 26405233DERIVED

  • 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.

    PMID: 24549163DERIVED

MeSH Terms

Conditions

Myocardial InfarctionAnterior Wall Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Anthony Mathur, FRCP FESC Ph

    Barts and the London NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 2, 2008

First Posted

October 3, 2008

Study Start

March 1, 2008

Primary Completion

March 1, 2014

Study Completion

March 1, 2018

Last Updated

March 2, 2020

Record last verified: 2020-02

Locations

CH(1)GB(3)DK(1)