Transplantation of Autologous Cardiac Stem Cells in Ischemic Heart Failure

NCT01758406 | Unknown Phase 2 DMC

• 1 other identifier: Royan-Heart-003
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, randomized, double blind , controlled trial to assess the efficacy of intracoronary transplantation of autologous cardiac stem cells in 50 patients with ischemic heart failure.

Conditions

Heart Failure

Keywords

Cardiac stem ce heart failure cardiac function intracoronary transplantation

Outcome Measures

Primary Outcomes (3)

• death

  evaluation the rate of patients mortality after cardiac stem cell transplantation.

  18months

• arrhythmia

  Evaluation rate of arrhythmia after cardiac stem cell transplantation

  18months

• hospitalization

  Evaluation the rate of hospitalization after cardiac stem cell transplantation

  18 months

Secondary Outcomes (4)

• Ejectin fraction changes

  18months

• Pro BNP changes

  18months

• NYHA functional class

  18months

• 6MW test

  18months

Study Arms (2)

cardiac stem cell transplantation

EXPERIMENTAL

The patients with heart failure that underwent cardiac stem cell transplantation.

Biological: Intracoronary injection

Placebo

PLACEBO COMPARATOR

The patients with heart failure that underwent placebo injection.

Biological: Intracoronary injection of Placebo

Interventions

Intracoronary injection BIOLOGICAL

stem cell transplantation

Also known as: autologous cardiac stem cell intracoronary injection

cardiac stem cell transplantation

Intracoronary injection of Placebo BIOLOGICAL

Injection of Placebo via coronary arteries in patients with heart failure.

Placebo

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• EF≤40 (by Echocardiography) 2- Not responding to standard therapies for heart failure \>1m 3- NYHA class ≥ III 4- Myocardial infarction due to coronary artery atherosclerotic disease 5-An area of regional dysfunction, i.e., hypokinetic, akinetic, or dyskinetic (echocardiography or MRI) 6-No HIV/Viral hepatitis 7-Normal liver function (SGPT \< 3 times the upper reference range) 8-No or controlled diabetes (hemoglobin A1C \< 8.5%) 9- Ability to provide informed consent and follow-up with protocol procedures

You may not qualify if:

• prior ICD placement(\<2w)/Sustained ventricular arrhythmias 2-Cardiogenic shock 3- pregnancy and Child-bearing 4- Congenital / valvular heart disease

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, Iran

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Hamid Gourabi, PhD

  Head of Royan Institute

  STUDY CHAIR

• Nasser Aghdami, MD,PhD

  Head of Royan department of degenerative medicine

  STUDY DIRECTOR

• Ahmad Amin, MD

  Department of Heart failure,Shahid Rajaee Hospital

  STUDY DIRECTOR

• Farveh Vakilian, MD

  Department of Heart failure , Imam reza hospital, Mashhad, Iran

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nasser Aghdami, MD,PhD

CONTACT

+9821235622000; nasser.aghdami@royaninstitute.org

Leila Arab, MD

CONTACT

+982123562000; leila.arab@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2012
• First Posted: January 1, 2013
• Study Start: December 1, 2013
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 4, 2015

Record last verified: 2015-11

Locations

IR (1)