NCT00221182

Brief Summary

The purpose of this study is to determine if stem 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 relieve your chest pain, increase the blood flow, and/or improve the cardiac contractility (function) by regenerating blood vessels in your heart.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

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

Study Start

First participant enrolled

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

June 22, 2011

Status Verified

June 1, 2011

Enrollment Period

4 years

First QC Date

September 13, 2005

Last Update Submit

June 21, 2011

Conditions

Chest PainChronic Myocardial IschemiaCoronary Artery DiseaseAnginaMyocardial Infarction

Keywords

AnginaHeart diseasesPainVascular diseases

Outcome Measures

Primary Outcomes (2)

  • Efficacy: Severity of myocardial perfusion abnormality by sestamibi SPECT stress myocardial scintigraphy

  • Safety: Severe adverse events within 4 weeks after cell therapy

Secondary Outcomes (4)

  • CCSAS (Canada Cardiovascular Society Anginal Score)

  • NYHA (New York Heart Association) classification

  • Exercise tolerance by treadmill

  • Left ventricular function by cardiac MRI

Interventions

Autologous peripheral blood CD34 positive cell therapyGENETIC

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 6 months since last episode of myocardial infarction or at least 3 months since initial anginal episode.
  • Patients fulfilling either of the following criteria based on the extent of CAD by coronary angiography and LVEF by echocardiography.
  • Patients with single vessel CAD and LVEF \< 50%
  • Patients with multivessel CAD
  • Reversible myocardial ischemia as revealed by sestamibi SPECT stress myocardial scintigraphy.
  • Patients for whom angioplasty and bypass are not indicated because of anatomical or procedural reasons or frequent reocclusion/restenosis following traditional revascularization.
  • Age is between 20 and 80 (at time of consent).
  • Exercise tolerance time (ETT) duration ≥ 3 minutes and \< 13 minutes on a modified Bruce protocol on 2 consecutive tests (\> 24 hours but \< 2 weeks apart), with the difference between the 2 exercise times within 25% of their mean (Patients should not be informed of exercise restrictions required for entry into the study).
  • Patients who can give informed consent themselves in writing.

You may not qualify if:

  • Sustained ventricular tachycardia in a 24-hour ECG.
  • Chronic atrial fibrillation.
  • Less than 6 months since last episode of cerebral infarction.
  • Less than 6 months since last coronary angioplasty or less than 3 months since last bypass surgery.
  • Patients with unstable angina, with a treatment rating of 3 in the Braunwald system (refer to 5.4.), but a severity of III and a clinical rating of B or C.
  • Presence of left ventricular thrombus by echocardiography
  • Patients with a malignant tumor\*.
  • Patients with diabetic proliferating retinopathy\*\* (new Fukuda classification BI to BV).
  • Patients with chronic rheumatoid arthritis.
  • Patients with a history of severe allergic reactions or side effects to G-CSF preparations or apheresis.
  • Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes).
  • Patients currently suffering from or having a history of interstitial pneumonitis.
  • Patients for whom cranial MRA reveals cerebral aneurysm.
  • Patients for whom abdominal CT or ultrasonography reveals splenomegaly.
  • Patients with cirrhosis of the liver.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kobe Institute of Biomedical Research and Innovation

Kobe, Hyogo-Pref., 650-0047, Japan

Location

Kobe City General Hospital

Kobe, Hyōgo, Japan

Location

Okayama University School of Medicine

Okayama, Okayama-ken, 700-8530, Japan

Location

Related Publications (6)

  • Asahara T, Kawamoto A. Endothelial progenitor cells for postnatal vasculogenesis. Am J Physiol Cell Physiol. 2004 Sep;287(3):C572-9. doi: 10.1152/ajpcell.00330.2003.

    PMID: 15308462BACKGROUND

  • Kawamoto A, Tkebuchava T, Yamaguchi J, Nishimura H, Yoon YS, Milliken C, Uchida S, Masuo O, Iwaguro H, Ma H, Hanley A, Silver M, Kearney M, Losordo DW, Isner JM, Asahara T. Intramyocardial transplantation of autologous endothelial progenitor cells for therapeutic neovascularization of myocardial ischemia. Circulation. 2003 Jan 28;107(3):461-8. doi: 10.1161/01.cir.0000046450.89986.50.

    PMID: 12551872BACKGROUND

  • Kawamoto A, Gwon HC, Iwaguro H, Yamaguchi JI, Uchida S, Masuda H, Silver M, Ma H, Kearney M, Isner JM, Asahara T. Therapeutic potential of ex vivo expanded endothelial progenitor cells for myocardial ischemia. Circulation. 2001 Feb 6;103(5):634-7. doi: 10.1161/01.cir.103.5.634.

    PMID: 11156872BACKGROUND

  • Asahara T, Murohara T, Sullivan A, Silver M, van der Zee R, Li T, Witzenbichler B, Schatteman G, Isner JM. Isolation of putative progenitor endothelial cells for angiogenesis. Science. 1997 Feb 14;275(5302):964-7. doi: 10.1126/science.275.5302.964.

    PMID: 9020076BACKGROUND

  • Takahashi T, Kalka C, Masuda H, Chen D, Silver M, Kearney M, Magner M, Isner JM, Asahara T. Ischemia- and cytokine-induced mobilization of bone marrow-derived endothelial progenitor cells for neovascularization. Nat Med. 1999 Apr;5(4):434-8. doi: 10.1038/7434.

    PMID: 10202935BACKGROUND

  • Kalka C, Masuda H, Takahashi T, Kalka-Moll WM, Silver M, Kearney M, Li T, Isner JM, Asahara T. Transplantation of ex vivo expanded endothelial progenitor cells for therapeutic neovascularization. Proc Natl Acad Sci U S A. 2000 Mar 28;97(7):3422-7. doi: 10.1073/pnas.97.7.3422.

    PMID: 10725398BACKGROUND

MeSH Terms

Conditions

Chest PainCoronary Artery DiseaseAngina PectorisMyocardial InfarctionHeart DiseasesPainVascular Diseases

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCoronary DiseaseMyocardial IschemiaCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesInfarctionIschemiaPathologic ProcessesNecrosis

Study Officials

  • Takayuki Asahara, M.D.

    Foundation for Biomedical Research and Innovation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

September 1, 2005

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

June 22, 2011

Record last verified: 2011-06

Locations

JP(3)