NCT00395811

Brief Summary

The purpose of this study is to determine whether intracoronary transfer of autologous bone marrow cells can induce angiogenesis, subsequently improving regional myocardial perfusion, and finally resulting in improved systolic and diastolic left ventricular function in patients with myocardial infarction. 50 patients with stable left ventricle function will - with six months interval - receive two treatments with bone marrow transplantation intracoronary in vessels supplying dysfunctional myocardial territories and Coronary Artery Bypass Graft (CABG).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2007

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

October 29, 2008

Status Verified

October 1, 2008

Enrollment Period

2.2 years

First QC Date

November 1, 2006

Last Update Submit

October 28, 2008

Conditions

Coronary DiseaseMyocardial Infarction

Keywords

Myocardial Infarctionstem cell therapyCoronary Artery Bypass Grafting

Outcome Measures

Primary Outcomes (1)

  • Changes in left ventricular ejection fraction from baseline to 6 months' follow-up

    3 year

Interventions

Bone Marrow Stem Cell Therapy combined CABGPROCEDURE

Bone Marrow Stem Cell inject into myocardium

Eligibility Criteria

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

You may qualify if:

  • Patients with coronary disease undergoing CABG.
  • At least 3 months since last episode of myocardial infarction
  • Patients fulfilling either of the following criteria based on the extent of CAD by coronary angiography and LVEF by echocardiography.
  • Reversible myocardial ischemia as revealed by SPECT. ejection fraction \>=40% \<=50%. Age \>=18 years and \<=70 Patients who can give informed consent themselves in writing.
  • Negative pregnancy test (in women with childbearing potential).

You may not qualify if:

  • Sustained ventricular tachycardia in a 24-hour ECG.
  • Chronic atrial fibrillation.
  • Less than 3 months since last episode of cerebral infarction.
  • Patients with a malignant tumor\*.
  • Patients with chronic rheumatoid arthritis.
  • Patients with a history of severe allergic reactions.
  • Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes).
  • Patients currently suffering from or having a history of interstitial pneumonitis.
  • Leukocytes less than 4,000/µL or exceeding 10,000/µL.
  • Platelets less than 100,000/µL.
  • Hemoglobin less than 10 g/dL.
  • AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L.
  • Patients for whom it is impossible to perform both cardiac MRI
  • Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period.
  • Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai cardiovascular disease hospital

Beijing, 100037, China

Location

Related Publications (1)

  • Hu S, Liu S, Zheng Z, Yuan X, Li L, Lu M, Shen R, Duan F, Zhang X, Li J, Liu X, Song Y, Wang W, Zhao S, He Z, Zhang H, Yang K, Feng W, Wang X. Isolated coronary artery bypass graft combined with bone marrow mononuclear cells delivered through a graft vessel for patients with previous myocardial infarction and chronic heart failure: a single-center, randomized, double-blind, placebo-controlled clinical trial. J Am Coll Cardiol. 2011 Jun 14;57(24):2409-15. doi: 10.1016/j.jacc.2011.01.037.

    PMID: 21658561DERIVED

MeSH Terms

Conditions

Coronary DiseaseMyocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Hu shengshou

    National center for cardiovascular disease ,china

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 1, 2006

First Posted

November 3, 2006

Study Start

January 1, 2007

Primary Completion

April 1, 2009

Study Completion

June 1, 2009

Last Updated

October 29, 2008

Record last verified: 2008-10

Locations

CN(1)