Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 31
- Locations
- 2
- Primary Endpoint
- Improvement in myocardial perfusion measured by SPECT
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Improvement in myocardial perfusion measured by SPECT
Time Frame: 6 months after treatment
Secondary Outcomes
- 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)
Investigators
JKastrup
Professor
Rigshospitalet, Denmark