deltatrials
Terminated PHASE1/PHASE2 INTERVENTIONAL NCT00221182

Stem Cell Study for Patients With Heart Disease

Phase I / II Clinical Trial Regarding Vascular Regeneration Therapy by Transplantation of Autologous Peripheral Blood Endothelial Progenitor Cells (CD34+ Cells) in No-Option Patients With Chronic Myocardial Ischemia

Sponsor: Foundation for Biomedical Research and Innovation

Updated 5 times since 2017 Last updated: Jun 21, 2011 Started: Sep 30, 2005 Primary completion: Sep 30, 2009 Completion: Sep 30, 2009
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

slow recruitment of the study subjects

A PHASE1/PHASE2 clinical study on Angina and Chest Pain, this trial is terminated or withdrawn. The trial is conducted by Foundation for Biomedical Research and Innovation and has accumulated 5 data snapshots since 2005. Cardiovascular trials of this type often inform treatment guidelines for long-term patient management.

Study Description(click to expand)

Chronic myocardial ischemia (MI) is a progressive disease, which arises as a result of atherosclerosis in coronary arteries. Prognosis of chronic MI is poor, and no effective treatments have been established in patients who are not eligible for the traditional revascularization therapies such as angioplasty and bypass procedures due to the inappropriate anatomy of the coronary arteries or frequent reocclusion following revascularization. Therefore, it is necessary to establish novel revascularization treatment to improve prognosis of the no-option patients. We will study the safety and clinical efficiency of vascular regeneration by means of transplantation of autologous peripheral blood endothelial progenitor cells (CD34 positive cells) in patients with severe chronic coronary artery disease (CAD) who are not eligible for traditional revascularization treatments. The primary endpoint is the severity of myocardial ischemia identified by sestamibi SPECT stress myocardial scintigraphy and the evaluation of adverse effect rates, while the secondary endpoints are evaluation of CCSAS and NYHA classification, regional myocardial blood flow as revealed by PET scan, and various left ventricular function indices.

Chronic myocardial ischemia (MI) is a progressive disease, which arises as a result of atherosclerosis in coronary arteries. Prognosis of chronic MI is poor, and no effective treatments have been established in patients who are not eligible for the traditional revascularization therapies such as angioplasty and bypass procedures due to the inappropriate anatomy of the coronary arteries or frequent reocclusion following revascularization. Therefore, it is necessary to establish novel revascularization treatment to improve prognosis of the no-option patients. We will study the safety and clinical efficiency of vascular regeneration by means of transplantation of autologous peripheral blood endothelial progenitor cells (CD34 positive cells) in patients with severe chronic coronary artery disease (CAD) who are not eligible for traditional revascularization treatments. The primary endpoint is the severity of myocardial ischemia identified by sestamibi SPECT stress myocardial scintigraphy and the evaluation of adverse effect rates, while the secondary endpoints are evaluation of CCSAS and NYHA classification, regional myocardial blood flow as revealed by PET scan, and various left ventricular function indices.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 19 months · monthly snapshotTerminated

Change History

5 versions recorded
  1. Sep 2024 — Present [monthly]

    Terminated PHASE1/PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

  3. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE1_PHASE2

  4. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE1_PHASE2

  5. Jan 2017 — Jun 2018 [monthly]

    Terminated PHASE1_PHASE2

    First recorded

Sep 2005

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Foundation for Biomedical Research and Innovation
  • Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan
  • Kobe City General Hospital
  • Okayama University School of Medicine
Data source: Foundation for Biomedical Research and Innovation

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations