NCT00203203

Brief Summary

This is a phase 1, single-blind trial to evaluate using autologous bone marrow mononuclear stem cells in ischemic cardiomyopathy patients. The patients must have a Left Ventricular Ejection Fraction (LVEF) of less than or equal to 45%. Once the patient meets all inclusion criteria, and no exclusion criteria are found, the subject is consented for the study, and extensive baseline testing is performed at St Luke's Hospital in Houston. Once all baseline testing criteria is met, the patient has their own bone marrow harvested and later that day the subject is taken to a cardiac catheterization lab where left ventricular electromechanical mapping using NOGA software (NOGA mapping) is performed and the processed stem cells are injected under electromechanical guidance into the affected areas of the left ventricle. The patient is usually discharged home the next day and returns for follow up visits at weeks 1, 2, 4, 6, 8, 12, months 6 and 12 and for phone call follow-up at months 4, 5, 7, 8, 9, 10, 11. Patients undergo extensive testing at most of these follow-up visits, including repeat cardiac catheterization with NOGA mapping at month 6 after stem cell injection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_1

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

Study Start

First participant enrolled

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

January 30, 2013

Completed
Last Updated

November 28, 2016

Status Verified

October 1, 2016

Enrollment Period

4.3 years

First QC Date

September 12, 2005

Results QC Date

July 6, 2011

Last Update Submit

October 17, 2016

Conditions

Ischemic Cardiomyopathy

Keywords

AutologousCardiacStem CellTransplant

Outcome Measures

Primary Outcomes (1)

  • Safety of Autologous-bone-marrow Injections

    Safety of cell injections was assessed by reviewing adverse events at 3 time points: (1) up to 2 weeks post-procedure), (2) 3 months post-procedure, and (3) at 6 months post-procedure. Major adverse events were adjudicated (hospitalization, arrhythmia, exacerbation of congestive HF \[CHF\], acute coronary syndrome, myocardial infarction, stroke, or death).

    up to 2 weeks post-procedure, 3 months and 6 months

Secondary Outcomes (12)

  • Canadian Cardiovascular (CCS) Angina Score

    baseline, 3 months and 6 months

  • New York Heart Association (NYHA)Classification

    baseline, 3 months and 6 months

  • Myocardial Oxygen Consumption (MVO2)

    baseline, 3 months and 6 months

  • Echocardiography (EF)Percent (%)

    baseline, 3 months and 6 months

  • Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 Slope)

    baseline and 3 months

  • +7 more secondary outcomes

Study Arms (2)

Stem Cell Therapy

EXPERIMENTAL

Subject is randomized to receive Stem Cell Therapy (intramyocardial injection of stem cells) via NOGA mapping.

Device: Intramyocardial Injection of stem cells via NOGA Mapping

Control, then Stem Cell Therapy

OTHER

Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy.

Other: Control, then Stem Cell Therapy

Interventions

Intramyocardial Injection of stem cells via NOGA MappingDEVICE

Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping to deliver cells in the active arm of the protocol.

Also known as: NOGA Star catheter and Myostar Injection.
Stem Cell Therapy
Control, then Stem Cell TherapyOTHER

Subject is randomized to receive a NOGA mapping and no injections (sham treatment)at time of active enrollment and treatment then offered stem cell therapy at 6 months.

Also known as: cross-over
Control, then Stem Cell Therapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • LVEF less than 45%
  • Functional class III or IV angina
  • At least 7% reversibility by Single Photon Emission Computed Tomography (SPECT) nuclear study
  • there are additional inc. criteria

You may not qualify if:

  • AGe \<18 or \>70 years of age
  • Constant atrial fibrillation
  • Left ventricular (LV) thrombus
  • History of malignancy in the last 5 years
  • LV wall thickness of \< 8 mm at the target site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Heart Institute/Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Perin EC, Silva GV, Henry TD, Cabreira-Hansen MG, Moore WH, Coulter SA, Herlihy JP, Fernandes MR, Cheong BY, Flamm SD, Traverse JH, Zheng Y, Smith D, Shaw S, Westbrook L, Olson R, Patel D, Gahremanpour A, Canales J, Vaughn WK, Willerson JT. A randomized study of transendocardial injection of autologous bone marrow mononuclear cells and cell function analysis in ischemic heart failure (FOCUS-HF). Am Heart J. 2011 Jun;161(6):1078-87.e3. doi: 10.1016/j.ahj.2011.01.028. Epub 2011 May 10.

    PMID: 21641354RESULT

Related Links

MeSH Terms

Interventions

Crossing Over, Genetic

Intervention Hierarchy (Ancestors)

Homologous RecombinationRecombination, GeneticGenetic Phenomena

Limitations and Caveats

The study is a preliminary study based on a small sample size which limits the statistical rigor of the analysis.

Results Point of Contact

Title
Emerson C. Perin, M.D., Ph.D.
Organization
Texas Heart Institute
eperin@texasheart.org
832-355-9405

Study Officials

  • Emerson Perin, MD,PhD.

    Texas Heart Institute/Baylor St Luke's Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Clinical Research for Cardiovascular Medicine and Director Stem Cell Center

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

April 1, 2004

Primary Completion

August 1, 2008

Study Completion

November 1, 2009

Last Updated

November 28, 2016

Results First Posted

January 30, 2013

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Data summarized and published. No need to share individual patient data.

Locations

US(1)