Autologous Mesenchymal Stromal Cell Therapy in Heart Failure
Primary Purpose
Congestive Heart Failure
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Mesenchymal stromal cell
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring heart failure, stem cell, mesenchymal stromal cell, mesenchymal stem cell
Eligibility Criteria
Inclusion Criteria:
- EF < 45 %
- NYHA 2 - 3
Exclusion Criteria:
- Acute coronary syndrome within last 6 weeks.
- Pregnancy
- FEV1 <1.0
- Cancer
- Any severe disease which could interfere with the treatment or the outcome
Sites / Locations
- The Heart Centre, Rigshospitalet University Hospital Copenhagen,
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
The number of mesenchymal stromal cells reached after two culture expansion passages.
Saline
Outcomes
Primary Outcome Measures
Improvements in left ventricular function
Secondary Outcome Measures
Clinical improvements
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00644410
Brief Title
Autologous Mesenchymal Stromal Cell Therapy in Heart Failure
Official Title
A Single Centre, Randomised Controlled Study of the Effect of NOGA-guided Direct Intramyocardial Injection of Mesenchymal Stromal Cells on the Development of New Myocardium and Blood Vessels in Patients With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
It is a single centre, randomised controlled study of the effect of NOGA-guided direct intramyocardial injection of mesenchymal stromal cells on the development of new myocardium and blood vessels in patients with heart failure.
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.
Detailed Description
The primary objective is to investigate the regenerative capacity of direct intra-myocardial injection of mesenchymal stromal cells in patients with reduced left ventricular EF (≤45%) and heart failure NYHA 2-3.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
heart failure, stem cell, mesenchymal stromal cell, mesenchymal stem cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
The number of mesenchymal stromal cells reached after two culture expansion passages.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Saline
Intervention Type
Biological
Intervention Name(s)
Mesenchymal stromal cell
Intervention Description
Mesenchymal stromal cells 20 - 40 mill.
Intervention Type
Biological
Intervention Name(s)
Saline
Intervention Description
12 injection with 0.2 ml saline
Primary Outcome Measure Information:
Title
Improvements in left ventricular function
Time Frame
6 and 12 months
Secondary Outcome Measure Information:
Title
Clinical improvements
Time Frame
6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
EF < 45 %
NYHA 2 - 3
Exclusion Criteria:
Acute coronary syndrome within last 6 weeks.
Pregnancy
FEV1 <1.0
Cancer
Any severe disease which could interfere with the treatment or the outcome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Kastrup, MD DMSc
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Heart Centre, Rigshospitalet University Hospital Copenhagen,
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
25926562
Citation
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.
Results Reference
derived
PubMed Identifier
22980293
Citation
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.
Results Reference
derived
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Autologous Mesenchymal Stromal Cell Therapy in Heart Failure
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