- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02057900
Transplantation of Human Embryonic Stem Cell-derived Progenitors in Severe Heart Failure (ESCORT)
9. juli 2018 opdateret af: Assistance Publique - Hôpitaux de Paris
Transplantation of Human Embryonic Stem Cell-derived CD15+ Isl-1+ Progenitors in Severe Heart Failure
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Heart failure due to coronary artery disease is a major problem because of its high prevalence, increased incidence and associated costs.
When conventional medical/interventional treatments fail and if cardiac transplantation is contra-indicated, alternate options need to be considered.
Transplantation of stem cells has emerged as one of them.
While the optimal cell type still remains debatable, there is compelling evidence that cells whose phenotype closely matches that of the recipient tissue look sound candidates.
In this context, human embryonic stem cells are attractive because of the possibility to drive their fate in vitro, prior to transplantation, towards a cardiac phenotype.
We have developed a process for achieving such a commitment and generating cardiac-directed cells.
The objective of this study is to assess both the feasibility and safety of this approach.
In addition, the disadvantages of multiple intramyocardial injections have now been recognized.
We have then taken advantage of the surgical setting of the trial (which entails concomitant coronary artery bypass or a mitral valve procedure) to switch from injections to the epicardial delivery of a fibrin gel into which the progenitor cells have been embedded.
Coverage of this cell-loaded patch by an autologous pericardial flap is finally designed to provide trophic factors to the underlying cellular graft with the hope of improving its viability.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
10
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Paris, Frankrig, 75015
- Department of Cardiovascular Surgery
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 81 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Human embryonic stem cell
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.
|
Epicardial delivery of a fibrin patch embedding human embryonic stem cell-derived CD15+ Isl-1+ progenitors
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
number and nature of adverse events
Tidsramme: Within the first year after surgery
|
Evidence for new clinical/biological abnormalities, occurrence of arrhythmias or development of a cardiac or extra-cardiac tumor.
|
Within the first year after surgery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Feasibility of patch's generation and its efficacy on cardiac functions
Tidsramme: Within the first year after surgery
|
Feasibility will be assessed by the ability to generate hESC-derived CD15+ Isl-1+ progenitors according to preset quality measures, to incorporate these cells in a fibrin patch, to deliver this patch onto the epicardium of the infarct area and to cover it with an autologous pericardial flap.
Efficacy will be assessed on the following end points : 1- left ventricular function; 2- viability of the grafted area; 3- functional status; 4- major adverse cardiovascular events.
|
Within the first year after surgery
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Philippe Menasché, MD, PhD, Department of Cardiovascular Surgery, Hôpital Européen Georges Pompidou, Paris, France
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
27. maj 2013
Primær færdiggørelse (Faktiske)
22. marts 2018
Studieafslutning (Faktiske)
22. marts 2018
Datoer for studieregistrering
Først indsendt
17. september 2013
Først indsendt, der opfyldte QC-kriterier
6. februar 2014
Først opslået (Skøn)
7. februar 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. juli 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. juli 2018
Sidst verificeret
1. juli 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P100303
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Iskæmisk hjertesygdom
-
Region SkaneTilmelding efter invitationHjertesvigt New York Heart Association (NYHA) klasse II | Hjertesvigt New York Heart Association (NYHA) klasse IIISverige
-
Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan... og andre samarbejdspartnereIkke rekrutterer endnuHjertesvigt, systolisk | Hjertesvigt med reduceret udstødningsfraktion | Hjertesvigt New York Heart Association Klasse IV | Hjertesvigt New York Heart Association Klasse IIIPolen
-
University of WashingtonAmerican Heart AssociationAfsluttetHjertesvigt, Kongestiv | Mitokondriel ændring | Hjertesvigt New York Heart Association Klasse IVForenede Stater
-
Novartis PharmaceuticalsAfsluttetPatienter, der med succes afslutter den 12-måneders behandlingsperiode i kernestudiet (de Novo Heart-modtagere), som var interesserede i at blive behandlet med EC-MPS
-
University Hospital, GasthuisbergUkendtTransient Left Ventricular Ballooning SyndromeBelgien
-
NYU Langone HealthRekrutteringTako-tsubo kardiomyopati | Takotsubo kardiomyopati | Broken Heart SyndromeForenede Stater
-
French Cardiology SocietyAfsluttet