Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia

Brief Summary

Official Title: “Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia”

Mesenchymal stem cells from the bone marrow can be stimulated to differentiate into endothelial cells and participate in the development of new blood vessels in ischemic tissue.

The aim of the study is in a phase I/II safety and efficacy study to evaluate the clinical effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial ischemia.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: July 2009

Detailed Clinical Trial Description

Mesenchymal stem cells from the bone marrow can be stimulated to differentiate into endothelial cells and participate in the development of new blood vessels in ischemic tissue.

The aim of the study is in a phase I/II safety and efficacy study to evaluate the clinical effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial ischemia.

4o patients with reversible ischemia on a SPECT will be treated with direct intramyocardial injections of autologous isolated and expanded mesenchymal stem cells.Clinical and objective evaluations will be performed at baseline and during 12 months follow-up.

Interventions Used in this Clinical Trial

  • Biological: stem cell
    • mesenchymal stromal cell

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: Mesenchymal stromal cell
    • Mesenchymal stromal cell

Outcome Measures for this Clinical Trial

Primary Measures

  • Improvement in myocardial perfusion measured by SPECT
    • Time Frame: 6 months after treatment
      Safety Issue?: No

Secondary Measures

  • Safety
    • Time Frame: 6 months after treatment
      Safety Issue?: Yes
  • Improvement in myocardial perfusion and function measured by PET and MR
    • Time Frame: 6 months after treatment
      Safety Issue?: No
  • Exercise time
    • Time Frame: 6 months after treatment
      Safety Issue?: No
  • Clinical angina status
    • Time Frame: 6 months after treatment
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Age 30 to 80 years Reversible ischemia on a stress SPECT Angina pectoris CCS class >_ 2 Reduced exercise time < 10 min No further revascularization options

Exclusion Criteria

  • Pregnant Present or history of cancer Proliferative retinopathy Systemic severe disease LVEF < 25 % NYHA > II

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Rigshospitalet, Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: JKastrup, Professor – Rigshospitalet, Denmark
  • Overall Official(s)
    • Jens Kastrup, MD DMSc, Principal Investigator, Rigshospitalet, Denmark

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00260338