NCT00314366

Brief Summary

Recent studies have suggested that it may be possible to grow new blood vessels (angiogenesis) to supply the heart muscle that is currently not getting enough blood. One theory is that a certain type of stem cell, aldehyde dehydrogenase bright stem cells, may stimulate the growth of new vessels. After a bone marrow procedure, the special cells are separated and then injected back into the heart around the area of damage with a special guidance and injection system. Once a patient meets all inclusion criteria and no exclusion criteria, he/she will be consented to the study and extensive baseline testing will be completed at St. Luke's Episcopal Hospital in Houston, Texas. Once all baseline criteria are met, the patient has his/her own bone marrow harvested and later injected, if randomized to receive active treatment. The day after the bone marrow harvest, the patient is taken to the cardiac catheterization lab where NOGA mapping is performed and the processed cells or placebo 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 at weeks 1 and 4, and months 3 and 6, and at one year unless there is a crossover and then he/she begins baseline again at 6 months and follow-up for one more year. Follow-up testing, including quality of life and NOGA mapping, is done at the time of injection, as well as at 6 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for phase_1 coronary-artery-disease

Timeline
Completed

Started Apr 2006

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

Study Start

First participant enrolled

April 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

November 23, 2015

Completed
7.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2023

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

3.3 years

First QC Date

April 10, 2006

Results QC Date

June 5, 2015

Last Update Submit

April 18, 2024

Conditions

Coronary Artery Disease

Keywords

stem cellautologousischemia

Outcome Measures

Primary Outcomes (1)

  • Safety of Aldehyde Dehydrogenase Bright Stem Cells Versus the Control Group as Measured by Combined Early and Late Adverse Events

    Safety of cell injections was assessed by reviewing adverse events at 2 time points: Baseline (periprocedural period up to 2 weeks post-procedure) and 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).

    Baseline and 6 months

Secondary Outcomes (11)

  • New York Heart Association (NYHA) Classification

    Baseline and 6 months

  • Canadian Cardiovascular (CCS) Angina Score

    Baseline and 6 months

  • Echocardiography (EF)Percent (%)

    Baseline and 6 months

  • Left Ventricular End-Systolic Volume (LVESV) (ml)

    baseline and 6 months

  • Left Ventricular End-Diastolic Volume (LVEDV)

    baseline and 6 months

  • +6 more secondary outcomes

Study Arms (2)

Stem Cell Therapy

ACTIVE COMPARATOR

Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.

Biological: Stem Cell Therapy

Control

PLACEBO COMPARATOR

Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. At 6 months, subject is offered stem cell therapy and then followed for 12 months.

Other: Control (plasma)

Interventions

Stem Cell TherapyBIOLOGICAL

Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.

Also known as: NOGA Myostar catheter
Stem Cell Therapy
Control (plasma)OTHER

Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.

Control

Eligibility Criteria

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

You may qualify if:

  • Canadian cardiovascular (CV) Class II-IV angina and/or congestive heart failure (CHF) symptoms
  • Ejection fraction less than or equal to 45%
  • Reversible perfusion defect on single photon emission computed tomography (SPECT)
  • Coronary artery disease (CAD) unable to be corrected by surgery (bypass) or intervention (stent)
  • Able to walk on treadmill
  • Hemodynamically stable

You may not qualify if:

  • Age less than 18 or greater than 70
  • Atrial fibrillation
  • Severe valve disease
  • History of cancer in last 5 years
  • HIV positive; hepatitis B or C positive.
  • Left ventricular wall thickness less than 8 mm
  • Recent heart attack within the last 30 days

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, Zheng Y, Gahremanpour A, Canales J, Patel D, Fernandes MR, Keller LH, Quan X, Coulter SA, Moore WH, Herlihy JP, Willerson JT. Randomized, double-blind pilot study of transendocardial injection of autologous aldehyde dehydrogenase-bright stem cells in patients with ischemic heart failure. Am Heart J. 2012 Mar;163(3):415-21, 421.e1. doi: 10.1016/j.ahj.2011.11.020. Epub 2012 Feb 10.

    PMID: 22424012BACKGROUND

Related Links

MeSH Terms

Conditions

Coronary Artery DiseaseIschemia

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

April 10, 2006

First Posted

April 13, 2006

Study Start

April 1, 2006

Primary Completion

August 1, 2009

Study Completion

August 24, 2023

Last Updated

April 23, 2024

Results First Posted

November 23, 2015

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Relevant results are summarized and published. No need for individual results to be shared.

Locations

US(1)