Treatment of Heart Failure Using Human Umbilical Cord Mesenchymal Stem Cells(hUC-MSC)
16. juni 2021 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Forventet)
20
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Zhongmin Liu, Doctor
- Telefonnummer: +86-021-38804518
- E-post: liu.zhongmin@tongji.edu.cn
Studiesteder
-
-
Shanghai
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Shanghai, Shanghai, Kina, 200120
- Rekruttering
- Shanghai East Hospital, Shanghai Tongji University
-
Ta kontakt med:
- Zhongmin Liu, Doctor
- Telefonnummer: +86-021-38804518
- E-post: liu.zhongmin@tongji.edu.cn
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Ikke eldre enn 70 år (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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 inngripen: CABG group
CABG was performed under general anesthesia.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
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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
|
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Stroke volume
Tidsramme: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
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The change in Stroke volume (SV) ml after the operation
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Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
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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
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Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
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6 minutes walking distance
Tidsramme: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
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The change in 6 minutes walking distance m after the operation
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Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL) -BREF
Tidsramme: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
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The change in THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL) -BREF after the operation
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Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Zhongmin Liu, Doctor, Shanghai East Hospital, Shanghai Tongji University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
27. november 2019
Primær fullføring (Forventet)
31. juli 2022
Studiet fullført (Forventet)
30. november 2022
Datoer for studieregistrering
Først innsendt
3. desember 2020
Først innsendt som oppfylte QC-kriteriene
16. juni 2021
Først lagt ut (Faktiske)
25. juni 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. juni 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. juni 2021
Sist bekreftet
1. juni 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MR-31-20-000323
Plan for individuelle deltakerdata (IPD)
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Nei
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