NCT00474461

Brief Summary

The purpose of this study is to investigate the safety of intracoronary cardiac stem cells (CSCs) therapy in humans. Currently, there is no effective intervention to regenerate (regrow) dead heart muscle after a heart attack. The central hypothesis is that CSCs infused into nonviable myocardial segments will regenerate infarcted myocardium by differentiating into cardiomyocytes and other cell types. According to our hypothesis, CSC infusion regenerates myocardium with consequent improvement in contractile function of the heart and general clinical status.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P50-P75 for phase_1 coronary-artery-disease

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_1 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

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 15, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2007

Completed
1.7 years until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

4.5 years

First QC Date

May 15, 2007

Last Update Submit

April 8, 2017

Conditions

Coronary Artery DiseaseCongestive Heart Failure

Keywords

coronary artery diseaseHeart AttackHeart failureCardiac Stem CellsCoronary Artery Bypass

Outcome Measures

Primary Outcomes (1)

  • Monitoring adverse outcomes, death, sustained/symptomatic ventricular tachycardia, infection, bleeding, MI, stroke, peripheral embolism in the hospital after drug administration, in the first month after injection, and serially afterwards.

    1.5 years

Study Arms (2)

Treatment group

EXPERIMENTAL

Patients in this arm received intracoronary expanded autologous c-kit positive cardiac stem cells.

Biological: Treatment group

Control group

NO INTERVENTION

Patients in this arm did not receive any intervention.

Interventions

Treatment groupBIOLOGICAL

Intracoronary injection of cardiac stem cells

Also known as: Intracoronary Injection (cardiac stem cell therapy)
Treatment group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • LVEF \< 40% (by any imaging modality: echocardiography/SPECT/LV angiography)
  • A history of Q-wave MI with a residual akinetic and nonviable scar (as evidenced by low-dose dobutamine stress echocardiogram and/or or thallium redistribution nuclear study for viability and/or an electrocardiogram)
  • Patients scheduled for surgical revascularization within few days (\< 2 weeks) of the initial screening

You may not qualify if:

  • Age \>75 by time of infusion
  • Cardiogenic shock
  • Severe co-morbidities (e.g., renal failure, liver failure)
  • Mini-CABG procedures
  • Pregnant/nursing women or women of child-bearing potential
  • Inability to provide informed consent
  • Diabetic Hgb A1c \> 8.5%
  • Patients with a history of hepatitis B, hepatitis C, and HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

Related Publications (2)

  • Chugh AR, Beache GM, Loughran JH, Mewton N, Elmore JB, Kajstura J, Pappas P, Tatooles A, Stoddard MF, Lima JA, Slaughter MS, Anversa P, Bolli R. Administration of cardiac stem cells in patients with ischemic cardiomyopathy: the SCIPIO trial: surgical aspects and interim analysis of myocardial function and viability by magnetic resonance. Circulation. 2012 Sep 11;126(11 Suppl 1):S54-64. doi: 10.1161/CIRCULATIONAHA.112.092627.

    PMID: 22965994DERIVED

  • Bolli R, Chugh AR, D'Amario D, Loughran JH, Stoddard MF, Ikram S, Beache GM, Wagner SG, Leri A, Hosoda T, Sanada F, Elmore JB, Goichberg P, Cappetta D, Solankhi NK, Fahsah I, Rokosh DG, Slaughter MS, Kajstura J, Anversa P. Retracted: Cardiac stem cells in patients with ischaemic cardiomyopathy (SCIPIO): initial results of a randomised phase 1 trial. Lancet. 2011 Nov 26;378(9806):1847-57. doi: 10.1016/S0140-6736(11)61590-0. Epub 2011 Nov 14.

    PMID: 22088800DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseHeart FailureMyocardial Infarction

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Roberto Bolli, MD

    University of Louisville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the Division of Cardiovascular Medicine

Study Record Dates

First Submitted

May 15, 2007

First Posted

May 17, 2007

Study Start

February 1, 2009

Primary Completion

August 1, 2013

Study Completion

September 1, 2013

Last Updated

April 11, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

Locations

US(1)