Stem cell injection aims to repair hearts after major attack

NCT ID NCT02669810

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new treatment for people who had a severe heart attack and still have weak heart pumping. Doctors took the patients' own blood stem cells, grew more of them in a special machine, and injected them into the heart. The goal was to see if this could improve heart function and reduce serious heart problems compared to standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

49 people

The number who actually took part.

Started

Feb 2016

Finished

Mar 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria 1. LV main AMI with or without ST segment elevation and with a detection of rise of troponin with at least one value 70 times above the upper reference limit. 2. MI within 1 week after first symptoms. D0 = day of last stent implantation or; D0 = day of hospital presentation when no stent implanted. 3. Combination of LVEF \< 50% and LV akinetic or dyskinetic segment(s) - by echography as per local practice 4. Age must be ≥ 18 and ≤ 85 years 5. Men and Non-pregnant non-lactating women who take efficacious contraceptive measures such as oral contraceptive medications or efficacious and permanent intra-uterine device (drug eluted or not) (IUD) or subcutaneous permanent contraceptive implants or menopaused women (at least 2 years confirmed menopause) or surgically sterilized women. 6. Having previously signed a written informed consent prior to any study-specific procedure 7. LVEF remaining \< 50% assessed by cMRI at D8 (± 3) 8. Identification of LV segment(s) both non-viable (transmural scar extend \>50%) and akinetic (no cardiac wall thickening during systole) or dyskinetic (cardiac wall thickening in the wrong orientation during systole) by cMRI at D8 (± 3) Non-inclusion criteria 1. History of CABG surgery 2. History of former significant mitral valve replacement surgery or heart transplantation. 3. History of severe valve disease: mitral, aortic stenosis / insufficiency. 4. History of non-ischemic dilated cardiomyopathy due to valvular dysfunction, mitral regurgitation, tachycardia, or myocarditis. 5. Aortic stenosis as determined as valve area less than 1 cm2 that prohibits catheter access to LV. 6. Presence of a prosthetic / mechanical aortic or mitral valve or heart constrictive device. 7. Sepsis. 8. Endocarditis. 9. Infectious pericarditis; 10. Pericardial tamponade. 11. Left Ventricular Thrombus detected at Echo or MRI 12. Severe peripheral vascular disease precluding femoral artery access as determined at the time of original catheterization. 13. Any condition leading to contraindicated or unexploitable cMRI. 14. History of metallic foreign body in their eye 15. Former or current aortic dissection 16. Previous G-CSF or other hematopoietic growth factor administration. 17. Hepatic failure, history of liver cirrhosis or hepatic severe impairment. 18. Constitutional or acquired coagulopathy 19. Treated chronic renal failure, haemodialysis or renal severe impairment (creatinine clearance \< 30 ml/min). 20. Prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer or previous cancer in complete response without any treatment in the last 5 years. 21. History of prior mediastinal radiation exposure. 22. Serious underlying medical condition at the investigator's discretion, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, active autoimmune disease, Amyotrophic Lateral Sclerosis, Systemic Lupus, Multiple Sclerosis). 23. Chronic immunomodulatory or cytotoxic drug treatment intake. 24. Active bleeding or major surgery within 1 month. 25. History or current Human immunodeficiency HIV1-2, HTLV1, HTLV2 (according to 2006/17/EC). 26. Current Active Hepatitis B (according to 2006/17/EC) based on the decision of the biologist or/and the PI. 27. History or current Hepatitis C (according to 2006/17/EC). 28. Syphilis (according to 2006/17/EC) based on the decision of the biologist or/and the P. 29. Active participation in any other clinical trials. 30. Current or recent treatment (within two months) with another investigational drug or procedure. 31. Any other co-existing conditions that will preclude participation in the study or compromise ability to give informed consent. 32. Impairment of cognitive function. If patient is 75-85 years old (included), score \< 24 at Mini Mental State Examination (MMSE) 33. History of Splenomegaly; 34. History of Phenylketonuria; 35. History of iron-Dextran allergy; 36. History of murine protein allergy. 37. Diagnosis of Takotsubo Discontinuation criteria 1. Inadequate bone marrow function: patient at risk to have Haemoglobin \< 10 g/dL and Platelet count \< 100 x 109 /L at the time of blood harvest 2. Blood transfusion within the previous 3 days before the first G-CSF injection 3. Cardiogenic shock: requirement of i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump) initiated 24 hours before screening cMRI.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute myocardial infarction are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • BIRMINGHAM, Queen Elizabeth Hospital ,Mindelsohn Way,

    Edgbaston, B15 2GW, United Kingdom

  • CHU BESANCON Hopital Jean Minjoz 3 Boulevard A.Fleming

    Besançon, 25030, France

  • CHU DIJON Hôpital François Mitterrand 14 rue Gaffarel

    Dijon, 21079, France

  • CHU Montpellier Arnaud-De-Villeneuve

    Montpellier, France

  • CHU de Grenoble

    Grenoble, France

  • GHRMSA

    Mulhouse, France, 68100, France

  • Hôpital Haut Levèque

    Pessac, France

  • Hôpital de Rangueil

    Toulouse, France

  • Institut Jacques Cartier

    Massy, France

  • Leeds University & Leeds Teaching Hospitals NHS Trust

    Leeds, United Kingdom

  • Ninewells Hospital & Medical School

    Dundee, B15 2GW, United Kingdom

  • Saint Bartholomew's Hospital W Smithfield,

    London, EC1A 7BE, United Kingdom

  • University of Edinburgh

    Edinburgh, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.