Clinical trial NCT00644410: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Congestive Heart Failure
Keywords: heart failure
stem cell
mesenchymal stromal cell
mesenchymal stem cell
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2008-03-26
Enrollment: 59
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Improvements in left ventricular function
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Clinical improvements
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Heart Centre, Rigshospitalet University Hospital Copenhagen,
Study officials:
affiliation: Rigshospitalet, Denmark
name: Jens Kastrup, MD DMSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.