EXCELLENT (EXpanded CELL ENdocardiac Transplantation)

  • STATUS
    Recruiting
  • End date
    Jun 11, 2023
  • participants needed
    44
  • sponsor
    CellProthera
Updated on 11 July 2021
ejection fraction
troponin
coronary angioplasty

Summary

A multicentric controlled phase I / IIb study evaluating the safety and the efficacy of in vitro expanded peripheral blood CD34+ stem cells output by the StemXpand Automated Process, and injected in patients with an acute myocardial infarction and a LVEF remaining below 50% after reperfusion versus standard of care.

Description

The main purpose of this phase I/IIb is to evaluate the safety, the tolerance and the first efficacy trends of intracardiac injection of ProtheraCytes (autologous PB-CD34+ Stem Cells after automated ex-vivo expansion with the StemXpand machine) in patients with an acute myocardial infarction and decreased ejection fraction. ProtheraCytes will be reinjected using a dedicated catheter , thus avoiding open chest surgery.

Details
Condition Acute Myocardial Infarction
Treatment PROTHERACYTES, Standard of Care (Percutaneous Transluminal Coronary Angioplasty and stent(s) implantation), Standard Treatment for CHF post AMI
Clinical Study IdentifierNCT02669810
SponsorCellProthera
Last Modified on11 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
MI reperfused with or without stent implantation within 1 week after first symptoms. D0 = day of last stent implantation) or; D0 = day of hospital presentation when no stent implanted
Combination of LVEF < 50% and LV akinetic segment(s) - by echography as per local practice
Age must be 18 and 85 years
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
Having previously signed a written informed consent prior to any study-specific procedure
LVEF remaining < 50% assessed by cMRI at D8 ( 3)
Identification of LV akinetic and non-viable segment(s) by cMRI at D8 ( 3)
Non-inclusion criteria
History of CABG surgery
History of former significant mitral valve replacement surgery or heart transplantation
History of severe valve disease: mitral, aortic stenosis / insufficiency
History of non-ischemic dilated cardiomyopathy due to valvular dysfunction, mitral regurgitation, tachycardia, or myocarditis
Aortic stenosis as determined as valve area less than 1 cm2 that prohibits catheter access to LV
Presence of a prosthetic / mechanical aortic or mitral valve or heart constrictive device
Sepsis
Endocarditis
Infectious pericarditis
Pericardial tamponade
Severe peripheral vascular disease precluding femoral and/or radial artery access as determined at the time of original catheterization
Any condition leading to contraindicated or unexploitable cMRI
History of metallic foreign body in their eye
Former or current aortic dissection
Inadequate bone marrow function: patient at risk to have Haemoglobin < 10 g/dL or Platelet count < 100 x 109/L at the time of blood harvest
Previous G-CSF or other hematopoietic growth factor administration
Blood transfusion within 3 days before the first G-CSF injection
Hepatic failure, history of liver cirrhosis or hepatic severe impairment
Constitutional or acquired coagulopathy
Treated chronic renal failure, haemodialysis or renal severe impairment (creatinine clearance < 30 ml/min)
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
History of prior mediastinal radiation exposure
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)
Chronic immunomodulatory or cytotoxic drug treatment intake
Active bleeding or major surgery within 1 month
History or current Human immunodeficiency HIV1-2, HTLV1, HTLV2 (according to 2006/17/EC)
History or current Hepatitis B (prior vaccination accepted) (according to 2006/17/EC)
History or current Hepatitis C (according to 2006/17/EC)
Syphilis (according to 2006/17/EC)
Active participation in any other clinical trials
Current or recent treatment (within two months) with another investigational drug or procedure
Any other co-existing conditions that will preclude participation in the study or compromise ability to give informed consent
Impairment of cognitive function. If patient is 75-85 years old (included), score < 24 at Mini Mental State Examination (MMSE)
Cardiogenic shock: requirement of i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump) initiated 24 hours before screening cMRI
History of Splenomegaly
History of Phenylketonuria
History of iron-Dextran allergy
History of murine protein allergy
Takotsubo
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