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Acute Myocardial InfarctionPhase 2EXCELLENTNCT02669810

EXCELLENT (EXpanded CELL ENdocardiac Transplantation)

A Phase 2 study testing PROTHERACYTES and Standard Treatment for CHF post AMI in people with Acute Myocardial Infarction, run by CellProthera at 13 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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% versus standard of care. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
PROTHERACYTES and Standard Treatment for CHF post AMI
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
13 sitesin 2 countries
Study dates
10 Feb 2016to 15 Mar 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 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 or dyskinetic 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
Show all 50Show fewer
  • LVEF remaining < 50% assessed by cMRI at D8 (± 3)
  • 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
  • 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.
  • Left Ventricular Thrombus detected at Echo or MRI
  • Severe peripheral vascular disease precluding femoral 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
  • Previous G-CSF or other hematopoietic growth factor administration.
  • 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).
  • Current Active Hepatitis B (according to 2006/17/EC) based on the decision of the biologist or/and the PI.
  • History or current Hepatitis C (according to 2006/17/EC).
  • Syphilis (according to 2006/17/EC) based on the decision of the biologist or/and the P.
  • 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)
  • History of Splenomegaly;
  • History of Phenylketonuria;
  • History of iron-Dextran allergy;
  • History of murine protein allergy.
  • Diagnosis of Takotsubo
  • Discontinuation criteria
  • 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
  • Blood transfusion within the previous 3 days before the first G-CSF injection
  • Cardiogenic shock: requirement of i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump) initiated 24 hours before screening cMRI.

Who cannot join

None listed.

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

France8 sites

  • CHU BESANCON Hopital Jean Minjoz 3 Boulevard A.Fleming

    Besançon, 25030

  • CHU DIJON Hôpital François Mitterrand 14 rue Gaffarel

    Dijon, 21079

  • CHU de Grenoble

    Grenoble

  • Institut Jacques Cartier

    Massy

  • CHU Montpellier Arnaud-De-Villeneuve

    Montpellier

  • GHRMSA

    Mulhouse, France, 68100

  • Hôpital Haut Levèque

    Pessac

  • Hôpital de Rangueil

    Toulouse

Other trials in France

United Kingdom5 sites

  • Ninewells Hospital & Medical School

    Dundee, B15 2GW

  • BIRMINGHAM, Queen Elizabeth Hospital ,Mindelsohn Way,

    Edgbaston, B15 2GW

  • University of Edinburgh

    Edinburgh

  • Leeds University & Leeds Teaching Hospitals NHS Trust

    Leeds

  • Saint Bartholomew's Hospital W Smithfield,

    London, EC1A 7BE

Other trials in United Kingdom

About this study

Official title: EXpanded CELL ENdocardiac Transplantation (EXCELLENT)

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% versus standard of care.

Read the detailed 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.

Being tested
PROTHERACYTES, Standard Treatment for CHF post AMI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PROTHERACYTESDrug

    ProtheraCytes endocardiac injections performed with the HELIX and Morph catheters

  • Standard Treatment for CHF post AMIDrug

Study groups in NCT02669810
Study groupRoleWhat they receive
PROTHERACYTESExperimentalThe interventional investigators will perform the ProtheraCytes® cardiac injections using a catheter introduced via the femoral route up to the left ventricle cavity for intraventricular injections (Helix/Biocardia). Intracoronary injection will be possible with OTW catheter or microcatheter (UK only) if patient presents a contraindication to intramyocardial injection
Receives: Drug: PROTHERACYTES; Drug: Standard Treatment for CHF post AMI
Standard of CareActive comparatorPatients will be treated as standard treatment for CHF post - AMI.
Receives: Drug: Standard Treatment for CHF post AMI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Adverse Cardiac Events (MACE)

    The primary endpoint is the incidence of Major Adverse Cardiac Events (MACE), which have been adjudicated and confirmed to be a MACE by an independent and blinded Clinical Events Committee (CEC) from randomization

    Measured: From randomization up to 6 months

Secondary outcomes (3)

  1. Left Ventricle End Systolic Volume index (LVESVi)

    Improvement of LVESVi will be assessed by comparing cMRI at baseline, 3 and 6 months. The left ventricular volumes will be indexed to body surface area. cMRI will also assess other parameters such as:

    • Left ventricular end diastolic volume index (ml/m²)
    • Left ventricular ejection fraction (%)
    • Left ventricular mass (g)

    Measured: From Baseline up to 6 months

  2. Viability improvement of the infarcted segment(s)

    The viability assessment will be performed using cMRI and perfusion 99mTc SPECT (optional) respectively. A correlation assessment between LVESVi improvement and viability of the infarcted segment(s) will be statistically performed.

    Measured: From Baseline up to 6 months

  3. Other secondary outcomes measures

    Cardiac event free survival; Quality of life via SF36 scale

    Measured: From Baseline up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2016 (estimated)
  2. Study start10 Feb 2016
  3. Primary completion15 Mar 2024
  4. Study completion15 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02669810
Sponsor's protocol ID
EudraCT 2014-001476-63
Acronym
EXCELLENT
Status last verified
Apr 2024
First submitted
25 Jan 2016
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Roncalli J, Roubille F, Henon P, Marie PY, Montalescot G, Bhatt DL, Trebuchet G, de Kalbermatten M, Garitaonandia I, Smadja DM. TransEndocardial Injection of Autologous Expanded CD34+ Stem Cells (ProtheraCytes(R)) after myocardial infarction: Impact on Patients' Quality of Life. Stem Cell Rev Rep. 2026 May;22(4):1800-1810. doi: 10.1007/s12015-026-11098-5. Epub 2026 Mar 3.

    PubMed 41774093

  • Roncalli J, Roubille F, Meyer N, Pompilio G, Leroux L, Henon P, Trebuchet G, Criquet A, de Kalbermatten M, Saloux E, Manrique A, Marie PY, Bhatt DL, Solomon SD, Montalescot G, Newby DE, Zannad F; EXCELLENT Trial Investigators. Transendocardial injection of expanded autologous CD34+ cells after myocardial infarction: Design of the EXCELLENT trial. ESC Heart Fail. 2025 Apr;12(2):1455-1463. doi: 10.1002/ehf2.15124. Epub 2024 Dec 15.

    PubMed 39676512

  • Roncalli J, Roubille F, Cottin Y, Leroux L, Mathur A, Irving J, Khan SQ, Meneveau N, Bresson D, Hovasse T, Pompilio G, Matta A, Henon P, Trebuchet G, de Kalbermatten M, Garitaonandia I, Saloux E, Manrique A, Meyer N, Marie PY, Bhatt DL, Solomon SD, Montalescot G, Newby DE, Zannad F; EXCELLENT Trial Investigators. Transendocardial Injection of Expanded Autologous CD34+ Cells After Myocardial Infarction: Results of the EXCELLENT Trial. JACC Heart Fail. 2025 Nov;13(11):102626. doi: 10.1016/j.jchf.2025.102626. Epub 2025 Sep 9. No abstract available.

    PubMed 40929748

  • Bouis D, Goubaud A, Cormier A, Bennaoum S, Destalminil M, Schaffhauser H, Vignon C, de Kalbermatten M, Garitaonandia I. Development and Validation of Flow Cytometry-Based Method to Quantify CD34/CD45+ Cells as a Release Criterion of Clinical-Grade Products for a Phase III Clinical Trial. Cytometry A. 2026 Apr;109(4):273-289. doi: 10.1002/cyto.a.70028. Epub 2026 May 3.

    PubMed 42071167

  • Borlongan CV, Lee JY, D'Egidio F, de Kalbermatten M, Garitaonandia I, Guzman R. Nose-to-brain delivery of stem cells in stroke: the role of extracellular vesicles. Stem Cells Transl Med. 2024 Nov 12;13(11):1043-1052. doi: 10.1093/stcltm/szae072.

    PubMed 39401332

  • Aries A, Vignon C, Zanetti C, Goubaud A, Cormier A, Diederichs A, Lahlil R, Henon P, Garitaonandia I. Development of a potency assay for CD34+ cell-based therapy. Sci Rep. 2023 Nov 11;13(1):19665. doi: 10.1038/s41598-023-47079-8.

    PubMed 37952030

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PROTHERACYTES and Standard Treatment for CHF post AMI in people with Acute Myocardial Infarction, run by CellProthera at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 50 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Cardiac Events (MACE) (time frame: From randomization up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02669810, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026; AzTrials last refreshed its copy on 28 Oct 2026.

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