Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Ischemia Coronary Heart Disease |
Biological: stem cell |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia |
- Improvement in myocardial perfusion measured by SPECT
- Safety
- Improvement in myocardial perfusion and function measured by PET and MR
- Exercise time
- Clinical angina status
| Enrollment: | 31 |
| Study Start Date: | December 2005 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Mesenchymal stromal cell
Mesenchymal stromal cell
|
Biological: stem cell
mesenchymal stromal cell
|
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.
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Denmark | |
| Cardiovascular Lab. 2014, The Heart Centre, Rigshospitalet, Blegdamcvej 9 | |
| Copenhagen, Denmark, 2100 | |
| Principal Investigator: | Jens Kastrup, MD DMSc | Rigshospitalet, Denmark |
More Information
No publications provided
| Responsible Party: | Jens Kastrup Professor, Department of Cardiology |
| ClinicalTrials.gov Identifier: | NCT00260338 History of Changes |
| Other Study ID Numbers: | Jens Kastrup |
| Study First Received: | November 29, 2005 |
| Last Updated: | August 4, 2011 |
| Health Authority: | United States: Food and Drug Administration Denmark: De Videnskabsetiske Komiteer for Københavns og Frederiksberg Kommuner Denmark: Danish Medicines Agency |
Keywords provided by Rigshospitalet, Denmark:
|
myocardial ischemia stem cell mesenchymal myocardial perfusion |
Additional relevant MeSH terms:
|
Myocardial Ischemia Coronary Artery Disease Coronary Disease Heart Diseases Ischemia |
Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013