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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01449032 |
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Date of registration:
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06/10/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia (MyStromalCell Trial)
MyStromalCell |
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Scientific title:
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MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia (MyStromalCell Trial) |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01449032 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Jens Kastrup, MD Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Cardiology, Rigshospitalet |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- CCS III - IV
- Coronary artery stenosis/occlusion not treatable with invasive procedures
- LVEF > 40%
- ETT between 2 - 10 min
Exclusion Criteria:
- Valvular heart disease
- FEV1 < 1
- Severe systemic disease
- Acute coronary syndrome > 2 months
Age minimum:
30 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Ischemic Heart Disease
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Intervention(s)
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Biological: Saline
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Biological: MSC
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Primary Outcome(s)
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Exercise test
[Time Frame: 6 months]
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Secondary Outcome(s)
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Clinical evaluation
[Time Frame: 6 months]
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Secondary ID(s)
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MyStromalCell
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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