ICMNC-HF. IntraCoronary Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients (ICMNC-HF)

March 16, 2020 updated by: SCARM Institute, Tabriz, Iran

The Effect of Intracoronary Autologous Bone Marrow Derived Mononuclear Stem Cell Transplantation in Heart Failure (HF) Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intracoronary injection of stem cell
Autologous bone marrow-derived mononuclear cells injection in patients with Heart Failure
Biological: Intracoronary injection of stem cell
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.
Placebo Comparator: Placebo
Placebo injection via coronary arteries in patients with Heart Failure
Biological: Placebo
Injection of Placebo in patients with Heart failure via coronary arteries

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 12 months
The rate of patients mortality after transplantation
12 months
Hospitalization
Time Frame: 12 months
the rate of hospitalization after transplantation
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ejection fraction changes
Time Frame: 12 months
Elevation of ejection fraction in patients after transplantation
12 months
6-minute walk test (6MWT)
Time Frame: 12 months
Evaluation the improvement of 6MWT test after transplantation
12 months
Pro b-type natriuretic peptide (Pro-BNP) changes
Time Frame: 12 months
Elevation the reduction of Pro-BNP in patients after transplantation
12 months
NYHA functional class
Time Frame: 12 months
Evaluation the improvement of NYHA functional class in patients
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SCARM Institute, Tabriz, Iran

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Nasser Aslanabadi, MD, Cardiologist, Tabriz University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 28, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 2, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SCARM-Heart-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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