Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia

Phase 1

Completed

• Conditions: Myocardial Ischemia; Coronary Heart Disease
• Interventions: Biological: stem cell

• Registration Number: NCT00260338
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2005-11-29
• Study First Submitted QC: 2005-11-29
• Study Start: 2005-12
• Study First Posted: 2005-12-01
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-30
• Last Update Posted: 2013-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mesenchymal stromal cell	stem cell	Mesenchymal stromal cell

Primary Outcome Measures

Name	Time	Method
Improvement in myocardial perfusion measured by SPECT	6 months after treatment

Secondary Outcome Measures

Name	Time	Method
Safety	6 months after treatment
Improvement in myocardial perfusion and function measured by PET and MR	6 months after treatment
Exercise time	6 months after treatment
Clinical angina status	6 months after treatment

Trial Locations

Locations (1)

Cardiovascular Lab. 2014, The Heart Centre, Rigshospitalet, Blegdamcvej 9; 🇩🇰 Copenhagen, Denmark