A randomised trial to see if injecting patients' own bone marrow derived stem cells through their coronary artery changes mortality rate in patients after suffering from a heart attack

Phase 1

• Conditions: Myocardial Infarction with reduced Left Ventricular ejection fraction; MedDRA version: 19.1Level: PTClassification code 10000891Term: Acute myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-001495-11-GB
• Lead Sponsor: Queen Mary University London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-27
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

1. Signed and dated informed consent
2. Men and women of any ethnic origin aged = 18 years
3. Patients with acute STelevation (including new LBBB)
myocardial infarction as defined by the universal definition of AMI.
4. Successful acute reperfusion therapy (residual stenosis visually <50% and TIMI flow =2) within 24 hours of symptom
onset or thrombolysis within 12 hours of symptom onset followed by successful percutaneous coronary intervention
(PCI) within 24 hours after thrombolysis
5. Left ventricular ejection fraction = 45% with significant regional wall motion abnormality assessed by quantitative
echocardiography (central, independent core lab analysis) 3 to 6 days after reperfusion therapy
6. Open coronary artery suitable for cell infusion supplying the target area of abnormal wall motion
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 280
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

1. Participation in another clinical trial within 30 days prior to randomisation unless non interventional trials or trials where patients are randomised to only standard care and this has been discussed and agreed with the CI/sponsor prior to consenting.
2. Previously received stem/progenitor cell therapy
3. Pregnant or nursing women
4. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the
study or to follow the protocol
5. Necessity to revascularise additional vessels, outside the target coronary artery at the time of BMMNC
infusion
(additional revascularisations after primary PCI and before BMMNC
cell infusion are allowed), unless clinically indicated and according to latest guidelines. this decision should be made at the time of the index procedure and explicitly stated at the time
6. Cardiogenic shock requiring mechanical support
7. Platelet count <100,000/µl, or hemoglobin <8.5 g/dl
8. Impaired renal function, i.e. serum creatinine >2.5 mg/dl
9. Persistent fever or diarrhea not responsive to treatment within 4 weeks prior screening
10. Clinically significant bleeding within 3 months prior screening
11. Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg)
12. Life expectancy of less than 2 years from any noncardiac
cause or neoplastic disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified