Transplantation of Human Embryonic Stem Cell-derived Progenitors in Severe Heart Failure

NCT02057900 | Completed Phase 1 DMC

• 1 other identifier: P100303
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the feasibility and safety of a transplantation of cardiac-committed progenitor cells derived from human embryonic stem cells in patients with severe heart failure.

Conditions

Ischemic Heart Disease

Keywords

Postinfarction heart failure; Transplantation of human embryonic stem cell-derived cardiac progenitors; Tissue-engineered cellular graft; Fibrin hydrogel

Outcome Measures

Primary Outcomes (1)

• number and nature of adverse events

  Evidence for new clinical/biological abnormalities, occurrence of arrhythmias or development of a cardiac or extra-cardiac tumor.

  Within the first year after surgery

Secondary Outcomes (1)

• Feasibility of patch's generation and its efficacy on cardiac functions

  Within the first year after surgery

Study Arms (1)

Human embryonic stem cell

EXPERIMENTAL

Patients with ischemic heart failure receiving a fibrin gel embedding human embryonic stem cell-derived CD15+ Isl-1+ progenitors in addition to coronary artery bypass grafting and/or a mitral valve procedure.

Biological: Human embryonic stem cell-derived CD15+ Isl-1+ progenitors

Interventions

Human embryonic stem cell-derived CD15+ Isl-1+ progenitors BIOLOGICAL

Epicardial delivery of a fibrin patch embedding human embryonic stem cell-derived CD15+ Isl-1+ progenitors

Human embryonic stem cell

Eligibility Criteria

• Age: 18 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and less than 81 years
• Severe left ventricular systolic dysfunction with left ventricular ejection fraction (LVEF) ≤ 35% as assessed by echocardiography or scintigraphy
• History of myocardial infarction (older than 6 months) with a residual akinesia involving more than 2 (out of 16) contiguous segments, as assessed by basal echocardiography
• New York Heart Association (NYHA) Class III or IV despite optimal standard of care including diuretics and angiotensin receptor blockers and, if possible, beta blockers and aldosterone blockers
• Previous implantation of an automatic internal defibrillator associated, whenever indicated, to ventricular resynchronization
• Indication for a conventional cardiac surgical procedure : coronary artery bypass grafting involving, or not, the infarct area planned to be covered by the cell-loaded patch or mitral valve repair or replacement for ischemic mitral valve regurgitation; Non Eligibility to heart transplantation; Affiliation to a social security regimen
• Willingness and ability to give written informed consent

You may not qualify if:

• Pregnant or potentially child-bearing women
• Patients with poor echogenicity
• Left ventricular aneurysm
• Contra-indication to immunosuppressive drugs (history of cancer, infections like B or C hepatitis, positivity for Hepatitis-B, HIV, HTLV1)
• Contra-indication to sternotomy
• Alloimmunisation against the cell line from which the progenitors are derived
• Cardiogenic shock or NYHA Class IV heart failure requiring need for intravenous drugs
• Intellectual deterioration or psychiatric disease interfering with the ability to obtain an informed consent and to achieve a close follow-up of the patient
• Noncardiac disease which may reduce life expectancy in the short term
• Simultaneous participation to another trial

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Department of Cardiovascular Surgery

Paris, 75015, France

Location

Related Publications (2)

• Puymirat E, Geha R, Tomescot A, Bellamy V, Larghero J, Trinquart L, Bruneval P, Desnos M, Hagege A, Puceat M, Menasche P. Can mesenchymal stem cells induce tolerance to cotransplanted human embryonic stem cells? Mol Ther. 2009 Jan;17(1):176-82. doi: 10.1038/mt.2008.208. Epub 2008 Oct 7.

  PMID: 18841094 RESULT

• Menasche P, Vanneaux V, Hagege A, Bel A, Cholley B, Parouchev A, Cacciapuoti I, Al-Daccak R, Benhamouda N, Blons H, Agbulut O, Tosca L, Trouvin JH, Fabreguettes JR, Bellamy V, Charron D, Tartour E, Tachdjian G, Desnos M, Larghero J. Transplantation of Human Embryonic Stem Cell-Derived Cardiovascular Progenitors for Severe Ischemic Left Ventricular Dysfunction. J Am Coll Cardiol. 2018 Jan 30;71(4):429-438. doi: 10.1016/j.jacc.2017.11.047.

  PMID: 29389360 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Philippe Menasché, MD, PhD

  Department of Cardiovascular Surgery, Hôpital Européen Georges Pompidou, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2013
• First Posted: February 7, 2014
• Study Start: May 27, 2013
• Primary Completion: March 22, 2018
• Study Completion: March 22, 2018
• Last Updated: July 10, 2018

Record last verified: 2018-07

Locations

FR (1)