EXCELLENT (EXpanded CELL ENdocardiac Transplantation)

NCT02669810 | Completed Phase 2 DMC

• 1 other identifier: EudraCT 2014-001476-63
• Study Type: interventional
• Target: 49
• Locations: 2 countries
• Sites: 13

Brief 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.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (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

  From randomization up to 6 months

Secondary Outcomes (3)

• Left Ventricle End Systolic Volume index (LVESVi)

  From Baseline up to 6 months

• Viability improvement of the infarcted segment(s)

  From Baseline up to 6 months

• Other secondary outcomes measures

  From Baseline up to 6 months

Other Outcomes (3)

• Exploratory outcome measures

  From randomization up to 6 months

• Exploratory outcome measures

  From randomization up to 6 months

• Exploratory outcome measures

  From Baseline up to 6 months

Study Arms (2)

PROTHERACYTES

EXPERIMENTAL

The 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

Drug: PROTHERACYTES; Drug: Standard Treatment for CHF post AMI

Standard of Care

ACTIVE COMPARATOR

Patients will be treated as standard treatment for CHF post - AMI.

Drug: Standard Treatment for CHF post AMI

Interventions

PROTHERACYTES DRUG

ProtheraCytes endocardiac injections performed with the HELIX and Morph catheters

PROTHERACYTES

Standard Treatment for CHF post AMI DRUG

PROTHERACYTES; Standard of Care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)
• 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.

Sponsors & Collaborators

• CellProthera: lead

Study Sites (13)

GHRMSA

Mulhouse, France, 68100, France

Location

CHU BESANCON Hopital Jean Minjoz 3 Boulevard A.Fleming

Besançon, 25030, France

Location

CHU DIJON Hôpital François Mitterrand 14 rue Gaffarel

Dijon, 21079, France

Location

CHU de Grenoble

Grenoble, France

Location

Institut Jacques Cartier

Massy, France

Location

CHU Montpellier Arnaud-De-Villeneuve

Montpellier, France

Location

Hôpital Haut Levèque

Pessac, France

Location

Hôpital de Rangueil

Toulouse, France

Location

Ninewells Hospital & Medical School

Dundee, B15 2GW, United Kingdom

Location

BIRMINGHAM, Queen Elizabeth Hospital ,Mindelsohn Way,

Edgbaston, B15 2GW, United Kingdom

Location

University of Edinburgh

Edinburgh, United Kingdom

Location

Leeds University & Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Location

Saint Bartholomew's Hospital W Smithfield,

London, EC1A 7BE, United Kingdom

Location

Related Publications (5)

• 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 Mar 3. doi: 10.1007/s12015-026-11098-5. Online ahead of print.

  PMID: 41774093 BACKGROUND

• 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.

  PMID: 39676512 BACKGROUND

• 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.

  PMID: 40929748 RESULT

• 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.

  PMID: 39401332 DERIVED

• 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.

  PMID: 37952030 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: February 1, 2016
• Study Start: February 10, 2016
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: March 19, 2026

Record last verified: 2024-04

Locations

FR (8); GB (5)