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NCT00260338 Clinical Trial

Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia

Coronary Heart Disease Clinical Trial

Official title:
Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00260338
Other study ID # Jens Kastrup
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received November 29, 2005
Last updated May 30, 2013
Start date December 2005
Est. completion date July 2009

Study information
Verified date May 2013
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender All
Age group 30 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• stem cell
mesenchymal stromal cell

Locations
Country Name City State
Denmark Cardiovascular Lab. 2014, The Heart Centre, Rigshospitalet, Blegdamcvej 9 Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement in myocardial perfusion measured by SPECT 6 months after treatment
Secondary Safety 6 months after treatment
Secondary Improvement in myocardial perfusion and function measured by PET and MR 6 months after treatment
Secondary Exercise time 6 months after treatment
Secondary Clinical angina status 6 months after treatment
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