Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia
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ClinicalTrials.gov Identifier: NCT00260338 |
Recruitment Status :
Completed
First Posted : December 1, 2005
Last Update Posted : May 31, 2013
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Myocardial Ischemia Coronary Heart Disease | Biological: stem cell | Phase 1 Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 31 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia |
Study Start Date : | December 2005 |
Actual Primary Completion Date : | July 2009 |
Actual Study Completion Date : | July 2009 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Mesenchymal stromal cell
Mesenchymal stromal cell
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Biological: stem cell
mesenchymal stromal cell |
- Improvement in myocardial perfusion measured by SPECT [ Time Frame: 6 months after treatment ]
- Safety [ Time Frame: 6 months after treatment ]
- Improvement in myocardial perfusion and function measured by PET and MR [ Time Frame: 6 months after treatment ]
- Exercise time [ Time Frame: 6 months after treatment ]
- Clinical angina status [ Time Frame: 6 months after treatment ]

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Ages Eligible for Study: | 30 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00260338
Denmark | |
Cardiovascular Lab. 2014, The Heart Centre, Rigshospitalet, Blegdamcvej 9 | |
Copenhagen, Denmark, 2100 |
Principal Investigator: | Jens Kastrup, MD DMSc | Rigshospitalet, Denmark |
Responsible Party: | JKastrup, Professor, Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT00260338 |
Other Study ID Numbers: |
Jens Kastrup |
First Posted: | December 1, 2005 Key Record Dates |
Last Update Posted: | May 31, 2013 |
Last Verified: | May 2013 |
myocardial ischemia stem cell mesenchymal myocardial perfusion |
Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia Ischemia |
Cardiovascular Diseases Pathologic Processes Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases |