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Treatment of Heart Failure Using Human Umbilical Cord Mesenchymal Stem Cells(hUC-MSC)

16. juni 2021 opdateret af: Shanghai East Hospital
This study is an exploratory clinical study to observe the improvement of heart function before and after the treatment by human umbilical cord mesenchymal stem cells, and the purpose is to evaluate the safety and effectiveness of human umbilical cord mesenchymal stem cells in the treatment of heart failure. The study is a randomized parallel controlled study. Patients receive a review of which main content includes symptom improvement, cardiac function improvement, and adverse events.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is an exploratory clinical study to observe the improvement of heart function before and after the treatment by human umbilical cord mesenchymal stem cells, and the purpose is to evaluate the safety and effectiveness of human umbilical cord mesenchymal stem cells in the treatment of heart failure. The study is a randomized parallel controlled study. The research process is as follows: 1. Twenty eligible patients with ischemic heart disease were recruited, fully informed, and signed a consent form, and randomly divided into CABG group (n=10) or CABG + stem cell treatment group (n=10); 2. CABG was performed under general anesthesia in both groups. In the cell therapy group, 1×10^7 human umbilical cord Mesenchymal Stem Cells were injected to the edge of the myocardial infarction area at 20 points at the same time in CABG; 3. Use vasoactive drugs and antibiotics to prevent infection one week after surgery. After the operation, before discharge, 1 month, 3 months, 6 months, 12 months after discharge, and once a year thereafter, until the death of the patient. Patients receive a review of which main content includes symptom improvement, cardiac function improvement, and adverse events.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

20

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Shanghai
      • Shanghai, Shanghai, Kina, 200120
        • Rekruttering
        • Shanghai East Hospital, Shanghai Tongji University
        • Kontakt:

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

Ikke ældre end 70 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • The patients with coronary heart disease, the effect of drug treatment is not good, and the clinical manifestations of left ventricular insufficiency occur, EF<40%;
  • Coronary angiography confirmed that there is a chronic occlusive disease of the coronary artery, which is manifested as severe stenosis of single or multiple coronary vessels (≥75%), or even complete occlusion;
  • After the doctor explained the treatment process and possible toxic and side effects, he was willing to treat and agreed to cooperate in the observation of the efficacy. But patients can withdraw from clinical trials and long-term follow-up observation at any time and unconditionally;
  • The patient has no mental illness and language dysfunction and can fully understand the treatment method.

Exclusion Criteria:

  • Does not meet the above selection criteria;
  • Unable to sign the informed consent form, unable to comply with the agreed timetable of this study;
  • There are reasons to suspect that the patient was forced to join the trial;
  • Acute left ventricular insufficiency, cardiogenic shock;
  • The patient has any infectious diseases (including bacterial and viral infections);
  • Others who are clinically considered unsuitable for this treatment.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CABG with hUC-MSC treatment group
In the CABG with hUC-MSC treatment group, 1×10^7 human umbilical cord Mesenchymal Stem Cells were injected to the edge of the myocardial infarction area at 20 points at the same time in CABG.
Biologisk: Allogeneic Human Umbilical Cord Mesenchymal Stem Cells
In CABG with hUC-MSC treatment group, 1×10^7 Human Umbilical Cord Mesenchymal Stem Cells were injected at the edge of the myocardial infarction area at 20 points at the same time in CABG
Ingen indgriben: CABG group
CABG was performed under general anesthesia.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Left ventricular ejection fraction
Tidsramme: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
The change in Left ventricular ejection fraction (LVEF) % after the operation
Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
Left ventricular end diastolic volume
Tidsramme: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
The change in Left ventricular end diastolic volume (LVEDV) ml after the operation
Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
Left ventricular end systolic volume
Tidsramme: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
The change in Left ventricular end systolic volume (LVESV) ml after the operation
Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
Stroke volume
Tidsramme: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
The change in Stroke volume (SV) ml after the operation
Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
Left ventricular apex four-chamber end systolic diameter
Tidsramme: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
The change in Left ventricular apex four-chamber end systolic diameter (LVESD) mm after the operation
Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
6 minutes walking distance
Tidsramme: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
The change in 6 minutes walking distance m after the operation
Day 0, Day 30, Day 90, Day 180, Day 360, Day 720

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL) -BREF
Tidsramme: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
The change in THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL) -BREF after the operation
Day 0, Day 30, Day 90, Day 180, Day 360, Day 720

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shanghai East Hospital

Efterforskere

  • Ledende efterforsker: Zhongmin Liu, Doctor, Shanghai East Hospital, Shanghai Tongji University

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. november 2019

Primær færdiggørelse (Forventet)

31. juli 2022

Studieafslutning (Forventet)

30. november 2022

Datoer for studieregistrering

Først indsendt

3. december 2020

Først indsendt, der opfyldte QC-kriterier

16. juni 2021

Først opslået (Faktiske)

25. juni 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. juni 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juni 2021

Sidst verificeret

1. juni 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MR-31-20-000323

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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Kliniske forsøg med Myokardieiskæmi

Kliniske forsøg med Allogeneic Human Umbilical Cord Mesenchymal Stem Cells

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