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Rapid Delivery of Autologous Bone Marrow Derived Stem Cells in Acute Myocardial Infarction Patients. (AMIRST)

3. september 2013 opdateret af: TotipotentRX Cell Therapy Pvt. Ltd.

Intracoronary Infusion of Concentrated Autologous Bone Marrow Mononuclear Cells in Acute Myocardial Infarction Patients Utilizing a Novel Point-of-Care Device for Rapid-Delivery of Stem Cells (AMIRST)

The primary objective of the study is to determine the feasibility and safety of intracoronary administration of autologous bone marrow derived mononuclear cell product in patients at risk for clinically significant cardiac dysfunction following AMI.

The secondary objective of the study is to assess the effect on cardiac function and infarct region perfusion. A concurrent placebo control patient group meeting eligibility but not receiving autologous bone marrow derived stem cells will be evaluated similar to the treated group to assess the rate of significant spontaneous improvement in cardiac function.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Emerging evidence indicate that progenitor stem cells derived from bone marrow can be used to improve cardiac function in acute myocardial infarction patients. There is a great potential for stem cell therapy, using a variety of cell precursors to contribute to new blood vessel formation and muscle preservation in the myocardial infarct zone. The administration of cells via an infusion through the infarct related artery appears to be feasible and result in a clinical effect in some studies. Across the globe AMI is the leading cause of morbidity and mortality. This cannot be prevented by optimal standard therapies i.e. balloon or stent dilation of the infarct vessels.

The study is a double blind, placebo controlled, randomized, multicenter trial. Male or female patients between 18-75 years with first incidence of Acute Myocardial Infarction(AMI) and LVEF less than or equal to 40% are included in the study. Patients who have undergone successful percutaneous intervention (PCI) within ≤ 24 hours after onset of symptoms (PTCA/stent) or / and Thrombolysed patients having TIMI-3 flow are eligible to take part in the study.

A total of 30 subjects will be recruited and randomly assigned to receive concentrated BMMNC or placebo. All patients will undergo bone marrow aspiration within 3-10 days from the index event(infarction). Bone Marrow(BM) will be processed utilizing point of care technology. Following cell processing, the concentrated BMMNC or placebo control is infused directly into the infarct related artery using the stop flow method. Clinical follow up for all the subjects at 1,30, 60, 90, 180 and 360 days will be performed from the day of the procedure, with primary and secondary end points evaluated for both study arms.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

30

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

Undersøgelse Kontakt Backup

Studiesteder

  • Indien
      • Hyderabad, Indien, 500034
        • CARE Hospitals, Banjara Hills
        • Kontakt:
        • Ledende efterforsker:
          • Sreenivas A Kumar, MD, DM, FACC
        • Underforsker:
          • Venkatesh Ponemone, PhD
      • New Delhi, Indien, 110025
        • Fortis Escorts Heart Institute and Research Centre
        • Underforsker:
          • Venkatesh Ponemone, PhD
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Ashok Seth, FRCS, FSCAI
        • Underforsker:
          • Upendra Kaul, MD, DM, FACC
        • Underforsker:
          • Vishal Rastogi, MD, DM
        • Underforsker:
          • Vinay Sanghi, FACP,FACC
        • Underforsker:
          • Mona Bhatia, MD
      • New Delhi, Indien, 110070
        • Fortis Flt. Lt. Rajan Dhall Hospital
        • Underforsker:
          • Venkatesh Ponemone, PhD
        • Underforsker:
          • Mona Bhatia, MD
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Upendra Kaul, MD, DM, FACC
        • Underforsker:
          • Tapan Ghose, MD
        • Underforsker:
          • Ripen Gupta, MD
        • Underforsker:
          • Ranjan Kachru, MD

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 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male or Female of age 18 - 75 years
  • Incidence of first myocardial infarction
  • Acute STEMI with LV hypokinesia involving anteroseptal, lateral or inferior walls
  • LVEF < 40% pre-intervention
  • Successful percutaneous intervention (PCI) within ≤ 24 hours after onset of symptoms (PTCA/stent) or / and Thrombolysed patients having TIMI-3 flow.
  • Written informed consent

Exclusion Criteria:

  • Multi-vessel coronary disease requiring surgical intervention (CABG) or left main coronary artery disease > 50% blockage
  • Previous history of CABG
  • Pulmonary edema
  • Cardiogenic shock
  • Myocarditis
  • Renal or hepatic dysfunction
  • Hematologic disease

General Exclusion Criteria:

  • Alcohol or drug dependency, active or uncontrolled acute myocarditis
  • HIV, HBV, or HCV infections
  • Evidence of malignant or hematological diseases
  • Metal implants of any kind
  • Claustrophobia
  • Renal insufficiency
  • History of bleeding disorder
  • Anemia (haemoglobin <8.5mg/dl)
  • Platelet count <100,000/ml

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Treatment
Implantation of bone marrow derived mononuclear cells
Andet: Autologous Bone marrow mononuclear cells
Intracoronary administration of concentrated BMMNC on the same day of BM aspiration using point of care technology.
Andre navne:
  • BMMNC treatment group
Placebo komparator: Placebo Control
Infusion of autologous peripheral blood
Andet: Placebo control
Intracoronary infusion of autologous peripheral blood.
Andre navne:
  • Placebo kontrolgruppe

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of adverse events as a measure of safety
Tidsramme: 12 Months
Feasibility and safety of Intracoronary infusion of autologous BMMNCs processed through intraoperative point of care technology, freedom from arrhythmia's.
12 Months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in the global Left Ventricular Ejection Fraction(LVEF), LV volumes-End Systolic Volume (ESV) and End Diastolic Volume (EDV), infarct size, myocardial mass, myocardial viability and regional wall motion abnormalities.
Tidsramme: 12 Months
Changes in the global Left Ventricular Ejection Fraction(LVEF), LV volumes-End Systolic Volume (ESV) and End Diastolic Volume (EDV), infarct size, myocardial mass, myocardial viability and regional wall motion abnormalities measured by Cardiac MRI and assessed by central Core lab.
12 Months
Major adverse cardiac events (MACE)
Tidsramme: 12 Months
MACE was defined as the composites of any cause of death, myocardial infarction, revascularization of the target vessel, re-hospitalization for heart failure, and life-threatening arrhythmia.
12 Months
Quality of life
Tidsramme: 12 Months
Quality of life assessment is done using short-form 36, Minnesota living with heart failure questionnaire and Seattle Angina Questionnaire
12 Months

Samarbejdspartnere og efterforskere

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

Sponsor

TotipotentRX Cell Therapy Pvt. Ltd.

Samarbejdspartnere

TotipotentRX Corporation

Efterforskere

  • Studieleder: Venkatesh Ponemone, PhD, TotipotentRX Cell Therapy Pvt. Ltd.
  • Studiestol: Kenneth Harris, MS, TotipotentRX Cell Therapy Pvt. Ltd.
  • Ledende efterforsker: Ashok Seth, FRCP, FACC, Fortis Escorts Heart Institute and Research Centre
  • Ledende efterforsker: Upendra Kaul, MD,DM, FACC, Fortis Flt. Lt. Rajan Dhall Hospital
  • Ledende efterforsker: Sreenivas A Kumar, MD, DM, FACC, CARE Hospitals, Hyderabad, India

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

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

1. december 2013

Primær færdiggørelse (Forventet)

1. januar 2015

Studieafslutning (Forventet)

1. marts 2015

Datoer for studieregistrering

Først indsendt

16. juli 2011

Først indsendt, der opfyldte QC-kriterier

17. februar 2012

Først opslået (Skøn)

20. februar 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. september 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. september 2013

Sidst verificeret

1. september 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TPRX/POC/BMSC/AMIRST/1.0

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 Akut myokardieinfarkt

Kliniske forsøg med Autologous Bone marrow mononuclear cells

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Narkotikainterventioner

CROs by country

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Betingelser

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Placeringer

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