MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia (MyStromalCell Trial)
NCT ID: NCT01449032
Last Updated: 2014-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2010-04-30
2014-01-31
Brief Summary
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The investigators have established a double-blind placebo-controlled trial in patients with CAD to test efficacy and safety of treatment with adipose derived stem cells to improve perfusion in the heart muscle and exercise capacity, and reduce the patient's symptoms.
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Detailed Description
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The investigators have now established a double-blind placebo-controlled trial in patients with CAD to test efficacy and safety of treatment with MSCs to improve perfusion in the heart muscle and exercise capacity, and reduce the patient's symptoms.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MSC
Adipose derived stem cells
MSC
No of cells after culture expansion
Saline
Saline
3 cc saline
Interventions
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MSC
No of cells after culture expansion
Saline
3 cc saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Coronary artery stenosis/occlusion not treatable with invasive procedures
* LVEF \> 40%
* ETT between 2 - 10 min
Exclusion Criteria
* FEV1 \< 1
* Severe systemic disease
* Acute coronary syndrome \> 2 months
30 Years
80 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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JKastrup
Professor
Principal Investigators
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Jens Kastrup, MD Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiology, Rigshospitalet
Locations
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Rigshospitalet University Hospital Copenhagen
Copenhagen, , Denmark
Countries
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References
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Qayyum AA, Mathiasen AB, Helqvist S, Jorgensen E, Haack-Sorensen M, Ekblond A, Kastrup J. Autologous adipose-derived stromal cell treatment for patients with refractory angina (MyStromalCell Trial): 3-years follow-up results. J Transl Med. 2019 Nov 12;17(1):360. doi: 10.1186/s12967-019-2110-1.
Qayyum AA, Mathiasen AB, Mygind ND, Kuhl JT, Jorgensen E, Helqvist S, Elberg JJ, Kofoed KF, Vejlstrup NG, Fischer-Nielsen A, Haack-Sorensen M, Ekblond A, Kastrup J. Adipose-Derived Stromal Cells for Treatment of Patients with Chronic Ischemic Heart Disease (MyStromalCell Trial): A Randomized Placebo-Controlled Study. Stem Cells Int. 2017;2017:5237063. doi: 10.1155/2017/5237063. Epub 2017 Dec 3.
Other Identifiers
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MyStromalCell
Identifier Type: -
Identifier Source: org_study_id
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