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EXpanded CELL ENdocardiac Transplantation (EXCELLENT) (EXCELLENT)

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ClinicalTrials.gov Identifier: NCT02669810
Recruitment Status : Recruiting
First Posted : February 1, 2016
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
CellProthera

Tracking Information
First Submitted Date  ICMJE January 25, 2016
First Posted Date  ICMJE February 1, 2016
Last Update Posted Date July 8, 2019
Actual Study Start Date  ICMJE September 25, 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2016)
Proportion of adverse events (including MACE), defined as the proportion of subjects with at least one adverse event from baseline until 6 months. [ Time Frame: 6 Months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02669810 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2016)
Improvement of the Left Ventricle End Systolic Volume index will be assessed by cMRI. The left ventricular volumes will be indexed to body surface area. [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EXpanded CELL ENdocardiac Transplantation (EXCELLENT)
Official Title  ICMJE 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 Left Ventricle Ejection Fraction (LVEF) Remaining Below or Equal to 45% After PTCA and Stent(s) Implantation Versus Standard of Care.
Brief Summary 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 a De Novo acute myocardial infarction and decreased ejection fraction. ProtheraCytes will be reinjected using a dedicated catheter pushed through the femoral artery up to the left ventricle, thus avoiding open chest surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Myocardial Infarction
Intervention  ICMJE
  • Drug: PROTHERACYTES
    ProtheraCytes endocardiac injections performed with the HELIX and Morph catheters
  • Device: Standard of Care (Percutaneous Transluminal Coronary Angioplasty and stent(s) implantation)
Study Arms  ICMJE
  • Experimental: PROTHERACYTES
    The interventional investigators will perform the ProtheraCytes® endocardiac injections using the HELIX® catheter introduced via the femoral route up to the left ventricle cavity.
    Intervention: Drug: PROTHERACYTES
  • Active Comparator: Standard of Care
    Patients will undergo standard of care procedure (PTCA Percutaneous Transluminal Coronary Angioplasty and stent(s) implantations)
    Intervention: Device: Standard of Care (Percutaneous Transluminal Coronary Angioplasty and stent(s) implantation)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 27, 2016)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • De Novo Anterior wall AMI with or without ST segment elevation and with a detection of rise and/or fall of cardiac biomarker values (troponin) with at least one value above the 99th percentile of the upper reference limit.
  • LVEF ≤ 45% after stent(s) implantation: Combination of a LVEF ≤ 45 % and of anterior akinetic segment(s) - by echography at Day 2 after stent(s) mplantations
  • Age must be ≥ 18 and ≤ 75 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 a 2 years confirmed menopause) or surgically sterilized women.
  • Having previously signed a written informed consent prior to any study- specific procedures.
  • LVEF remaining ≤ 45% assessed by cMRI at Day 7 +/- 2 days after stent(s) implantation.
  • Identification of anterior akinetic segment(s) of interest assessed by cMRI at Day 7 +/- 2 days after stent(s) implantation.
  • Identification of non-viability of anterior segment(s) of interest assessed by perfusion 99mTc SPECT uptake at a day between Day 7 +/- 2 days and Day 10 +/- 2 days after stent(s) implantation.

Exclusion Criteria:

  • Absence of stent(s) implantation
  • Previous and known symptomatic CHF, from class II to IV (included)
  • History of CABG surgery
  • History of former significant mitral valve replacement surgery or heart transplantation.
  • Severe valve disease: mitral, aortic stenosis / insufficiency.
  • Diagnosis 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.
  • Documented presence of a known LV thrombus
  • Sepsis
  • Endocarditis
  • Infectious pericarditis
  • Pericardial tamponade
  • Left ventricular aneurysm, collagen tissue disease
  • Severe peripheral vascular disease precluding femoral artery access as determined at the time of original catheterization.
  • Pacemaker, implantable cardiac defibrillator, and intra-cerebral aneurysm clips.
  • History of metallic foreign body in their eye
  • Severe claustrophobia
  • Former or current aortic dissection
  • Inadequate bone marrow function: Haemoglobin < 10 g/dL and Platelet count < 100 x 109 / L
  • Previous G-CSF or other Hematopoietic Growth Factor administrations.
  • Blood transfusion(s) within the previous 4 weeks (to exclude the potential of non-autologous ACPs (Angiogenic Cells Precursors) in the harvested blood).
  • Hepatic failure or history of liver cirrhosis or hepatic severe impairment.
  • Constitutional or acquired coagulopathy
  • Treated chronic renal failure, or haemodialysis or renal severe impairment (creatinine clearance < 30ml/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 conditions 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 immunomudulatory or cytotoxic drug treatment intake.
  • Active bleeding or major surgery within 1 month.
  • Human immunodeficiency HIV1-2, HTLV1, HTLV2 (according to 2006/17/EC)
  • Hepatitis B (without prior vaccination) and C (according to 2006/17/EC)
  • Syphilis (according to 2006/17/EC)
  • Chronic Obstructive Pulmonary Disease.
  • Active participation in any other clinical trials
  • Current or recent treatment (within the 60 days period before PTCA and stent(s) implantation) with another investigational drug or procedure).
  • Any other co-existing medical or psychological condition that will preclude participation in the study or compromise ability to give informed consent.
  • Requirement of i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump) between Day 7 +/- 2 days and Day 10 +/- 2 days after stent(s) implantation.
  • Splenomegaly
  • Phenylacetonuria
  • History of iron-Dextran allergy
  • History of murin protein allergy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Frederic Flandrin 0033642743533 fflandrin@cellprothera.com
Listed Location Countries  ICMJE France,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02669810
Other Study ID Numbers  ICMJE EudraCT 2014-001476-63
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CellProthera
Study Sponsor  ICMJE CellProthera
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Frederic Flandrin CellProthera
PRS Account CellProthera
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP