NCT00620048

Brief Summary

The purpose of this study is to determine if cell therapy with your own cells (autologous cells) delivered with a catheter to regions of the heart with poor blood flow will be safe and if it will improve your ejection fraction and heart failure symptoms.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

February 7, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 21, 2008

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Last Updated

March 31, 2015

Status Verified

November 1, 2011

Enrollment Period

2.8 years

First QC Date

February 7, 2008

Last Update Submit

March 30, 2015

Conditions

Myocardial IschemiaCongestive Heart FailureCardiovascular Disease

Keywords

heartstem Cellslow EFheart attackcardiomyopathycongestive heart failurecardiovascular diseaseHeart FailureLow Ejection Fraction

Outcome Measures

Primary Outcomes (1)

  • Safety of intramyocardial administration of CD34-positive cells

    6 months

Secondary Outcomes (1)

  • Effects of intramyocardial injections of autologous CD34-positive cells on clinical outcomes.

    6 months

Study Arms (2)

Low dose of autologous CD34-positive cells (stem cells)

EXPERIMENTAL
Biological: Intramyocardial injection of autologous CD34-positive cells (stem cells)

High dose of autologous CD34-positive cells (stem cells)

EXPERIMENTAL
Biological: Intramyocardial injection of autologous CD34-positive cells (stem cells)

Interventions

Intramyocardial injection of autologous CD34-positive cells (stem cells)BIOLOGICAL

Comparison between a low dose and high dose of autologous (one's own) CD34-positive cells (stem cells) delivered via injections into the heart muscle.

High dose of autologous CD34-positive cells (stem cells)Low dose of autologous CD34-positive cells (stem cells)

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects 21 to 80 years old (inclusive).
  • Subjects with functional class (NYHA) II or III ischemic heart failure.
  • Subjects who have attempted "best" cardiac medical therapy including long-acting nitrates, maximal use of beta-adrenergic blocking agents, and angiotensin-converting enzyme (ACE)inhibitors without control of symptoms.
  • Subjects must be identified as non-candidates for conventional revascularization by their referring cardiologist.
  • Subjects must have left ventricular ejection fraction \<40% by echocardiography.
  • All subjects must have a recent coronary angiogram (within the last 6 months) to document the coronary anatomy and insure the presence of coronary disease that is not amenable to standard revascularization procedures.
  • Have serum B-type Natriuretic Peptide (BNP) level \>100 pg/ml.

You may not qualify if:

  • Myocardial infarction (Q wave or non-Q wave defined as CKMB \>3 times normal) within 30 days of treatment.
  • Successful coronary revascularization procedures within 3 months of study enrollment.
  • Documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment.
  • NYHA Class IV heart failure and patients with idiopathic or non-ischemic heart failure.
  • History of severe aortic stenosis (aortic valve area \< 1.0 cm2) or insufficiency (\>2+); severe mitral stenosis (mitral valve area \<1.5 cm2); or severe mitral insufficiency(\>2+).
  • Implantation of biventricular pacemaker within 90 days of study treatment.
  • Severe co-morbidity associated with a reduction in life expectancy of less than 1 year, such as chronic medical illness (i.e. severe chronic obstructive pulmonary disease, renal failure or cancer).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Myocardial IschemiaHeart FailureCardiovascular DiseasesMyocardial InfarctionCardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Douglas W. Losordo, M.D.

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2008

First Posted

February 21, 2008

Study Start

March 1, 2008

Primary Completion

January 1, 2011

Last Updated

March 31, 2015

Record last verified: 2011-11

Locations

US(1)