- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00260338
Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
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Copenhagen, Denmark, 2100
- Cardiovascular Lab. 2014, The Heart Centre, Rigshospitalet, Blegdamcvej 9
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Mesenchymal stromal cell
|
mesenchymal stromal cell
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement in myocardial perfusion measured by SPECT
Time Frame: 6 months after treatment
|
6 months after treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety
Time Frame: 6 months after treatment
|
6 months after treatment
|
Improvement in myocardial perfusion and function measured by PET and MR
Time Frame: 6 months after treatment
|
6 months after treatment
|
Exercise time
Time Frame: 6 months after treatment
|
6 months after treatment
|
Clinical angina status
Time Frame: 6 months after treatment
|
6 months after treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jens Kastrup, MD DMSc, Rigshospitalet, Denmark
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Jens Kastrup
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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