NCT03145402

Brief Summary

This is a prospective, randomised double blind, controlled, parallel-group phase I and II study. Its aim is to assess that a single intracoronary infusion of autologous bone marrow-mononuclear cells is safe and effective in hear failure patients with reduced left ventricular ejection fraction(\<=30%) when compared to a control group of patients undergoing best medical care.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for phase_1 heart-failure

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
3.5 years until next milestone

Study Start

First participant enrolled

October 20, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2021

Completed
Last Updated

March 17, 2020

Status Verified

December 1, 2019

Enrollment Period

10 months

First QC Date

May 2, 2017

Last Update Submit

March 16, 2020

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

  • Death

    The rate of patients mortality after transplantation

    12 months

  • Hospitalization

    the rate of hospitalization after transplantation

    12 months

Secondary Outcomes (4)

  • Ejection fraction changes

    12 months

  • 6-minute walk test (6MWT)

    12 months

  • Pro b-type natriuretic peptide (Pro-BNP) changes

    12 months

  • NYHA functional class

    12 months

Study Arms (2)

Intracoronary injection of stem cell

EXPERIMENTAL

Autologous bone marrow-derived mononuclear cells injection in patients with Heart Failure

Biological: Intracoronary injection of stem cell

Placebo

PLACEBO COMPARATOR

Placebo injection via coronary arteries in patients with Heart Failure

Biological: Placebo

Interventions

Intracoronary injection of stem cellBIOLOGICAL

Autologous bone marrow-derived mononuclear cells are obtained from 100-150ml of bone marrow aspirated under local anaesthesia from the iliac crest. Intracoronary infusion of the cells is performed in patients with Heart failure via conventional percutaneous intracoronary intervention techniques.

Intracoronary injection of stem cell
PlaceboBIOLOGICAL

Injection of Placebo in patients with Heart failure via coronary arteries

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women of any ethnic origin 18 ≤ aged≤ 65 years
  • EF≤40 (by Echocardiography) and regional wall motion abnormality
  • Not responding to standard therapies
  • the New York Heart Association (NYHA) class ≥ III
  • Myocardial infarction due to coronary artery atherosclerotic disease
  • An area of regional dysfunction, i.e., hypokinetic, akinetic, or dyskinetic (echocardiography or MRI)
  • Normal liver and renal function
  • No or controlled diabetes
  • Able to give voluntary written consent and understand the study information provided to him

You may not qualify if:

  • Participation in another clinical trial within 30 days prior randomisation
  • Previously received stem/progenitor cell therapy
  • Pregnant women
  • Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol
  • Cardiogenic shock requiring mechanical support
  • Congenital / valvular heart disease
  • Implantable cardioverter defibrillator (ICD) transplant
  • Platelet count \<100.000/µl, or hemoglobin \<8.5 g/dl
  • Impaired renal function, i.e. creatinine \>2.5 mg/dl
  • Fever or diarrhea within 4 weeks prior screening
  • History of bleeding disorder within 3 months prior screening
  • Uncontrolled hypertension (systolic \>180 mmHg and diastolic \>120 mmHg) or Sustained ventricular arrhythmia
  • Life expectancy of less than two years from any non-cardiac cause or uncontrolled neoplastic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stem Cell And Regenerative Medicine institute (SCARM)

Tabriz, Iran

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Nasser Aslanabadi, MD, Cardiologist

    Tabriz University of Medical Sciences

    STUDY DIRECTOR

  • Mohammad Nouri, Ph.D

    Head of SCARM institute

    STUDY CHAIR

  • Peyman Keyhanvar, MD, Ph.D

    Deputy for translational medicine of SCARM institute

    PRINCIPAL INVESTIGATOR

  • Raheleh Farahzadi, Ph.D

    Cardiovascular research center, Tabriz University of Medical Sciences, Tabriz, Iran

    PRINCIPAL INVESTIGATOR

  • Yousef Faridvand, Ph.D

    SCARM institute

    PRINCIPAL INVESTIGATOR

  • Elgar Anamzadeh, MD, Cardiologist

    Tabriz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nasser Aslanabadi, MD, Cardiologist

CONTACT

0413 33349525aslanabadin@yahoo.com

Peyman Keyhanvar, MD, Ph.D

CONTACT

0413 33349525drkeyhanvar@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2017

First Posted

May 9, 2017

Study Start

October 20, 2020

Primary Completion

August 28, 2021

Study Completion

October 2, 2021

Last Updated

March 17, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)