Autologous Mesenchymal Stromal Cell Therapy in Heart Failure
NCT ID: NCT00644410
Last Updated: 2015-03-17
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
PHASE1/PHASE2
59 participants
INTERVENTIONAL
2008-09-30
2015-03-31
Brief Summary
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Stem cells will be obtained from the bone marrow and culture expanded for 6 - 8 weeks before injected into the myocardium.
The patients will be followed with safety, clinical, MRI and CT endpoints for 1 year.
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Detailed Description
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A total of 60 patients with will be enrolled in the study and randomised 2: 1 to cells or placebo (saline).
The patients will be followed for 12 months. The primary endpoint is changes in left ventricle end-systolic volume (LVESV) at 6 months follow-up.
The secondary endpoints are changes in left ventricular ejection fraction (LVEF), end-diastolic volume and end-systolic mass at 6 months follow-up.
Other secondary endpoints are NYHA, CCS, Kansas City Cardiomyopathy Questionnaire (KCCQ), 6 min walking test, and major adverse events endpoints: all-causes death, cardiovascular death, and hospitalization for worsening heart failure and MI at 12 months follow-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
The number of mesenchymal stromal cells reached after two culture expansion passages.
Mesenchymal stromal cell
Mesenchymal stromal cells 20 - 40 mill.
2
Saline
Saline
12 injection with 0.2 ml saline
Interventions
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Mesenchymal stromal cell
Mesenchymal stromal cells 20 - 40 mill.
Saline
12 injection with 0.2 ml saline
Eligibility Criteria
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Inclusion Criteria
* NYHA 2 - 3
Exclusion Criteria
* Pregnancy
* FEV1 \<1.0
* Cancer
* Any severe disease which could interfere with the treatment or the outcome
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 DMSc
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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The Heart Centre, Rigshospitalet University Hospital Copenhagen,
Copenhagen, , Denmark
Countries
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References
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Mathiasen AB, Qayyum AA, Jorgensen E, Helqvist S, Fischer-Nielsen A, Kofoed KF, Haack-Sorensen M, Ekblond A, Kastrup J. Bone marrow-derived mesenchymal stromal cell treatment in patients with severe ischaemic heart failure: a randomized placebo-controlled trial (MSC-HF trial). Eur Heart J. 2015 Jul 14;36(27):1744-53. doi: 10.1093/eurheartj/ehv136. Epub 2015 Apr 29.
Mathiasen AB, Jorgensen E, Qayyum AA, Haack-Sorensen M, Ekblond A, Kastrup J. Rationale and design of the first randomized, double-blind, placebo-controlled trial of intramyocardial injection of autologous bone-marrow derived Mesenchymal Stromal Cells in chronic ischemic Heart Failure (MSC-HF Trial). Am Heart J. 2012 Sep;164(3):285-91. doi: 10.1016/j.ahj.2012.05.026.
Other Identifiers
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MSC heart failure
Identifier Type: -
Identifier Source: org_study_id
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