Stem cell injection aims to repair hearts after major attack
NCT ID NCT02669810
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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49 people
The number who actually took part.
- Started
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Feb 2016
- Finished
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Mar 2024
- Lead sponsor
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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
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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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
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BIRMINGHAM, Queen Elizabeth Hospital ,Mindelsohn Way,
Edgbaston, B15 2GW, United Kingdom
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CHU BESANCON Hopital Jean Minjoz 3 Boulevard A.Fleming
Besançon, 25030, France
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CHU DIJON Hôpital François Mitterrand 14 rue Gaffarel
Dijon, 21079, France
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CHU Montpellier Arnaud-De-Villeneuve
Montpellier, France
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CHU de Grenoble
Grenoble, France
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GHRMSA
Mulhouse, France, 68100, France
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Hôpital Haut Levèque
Pessac, France
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Hôpital de Rangueil
Toulouse, France
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Institut Jacques Cartier
Massy, France
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Leeds University & Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
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Ninewells Hospital & Medical School
Dundee, B15 2GW, United Kingdom
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Saint Bartholomew's Hospital W Smithfield,
London, EC1A 7BE, United Kingdom
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University of Edinburgh
Edinburgh, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Blood test clues: could two proteins predict heart failure after a heart attack?
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- Can a quick shot stop a heart attack in its tracks?