NCT00644410

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

6.5 years

First QC Date

March 20, 2008

Last Update Submit

March 16, 2015

Conditions

Congestive Heart Failure

Keywords

heart failurestem cellmesenchymal stromal cellmesenchymal stem cell

Outcome Measures

Primary Outcomes (1)

  • Improvements in left ventricular function

    6 and 12 months

Secondary Outcomes (1)

  • Clinical improvements

    6 and 12 months

Study Arms (2)

1

ACTIVE COMPARATOR

The number of mesenchymal stromal cells reached after two culture expansion passages.

Biological: Mesenchymal stromal cell

2

PLACEBO COMPARATOR

Saline

Biological: Saline

Interventions

Mesenchymal stromal cellBIOLOGICAL

Mesenchymal stromal cells 20 - 40 mill.

1
SalineBIOLOGICAL

12 injection with 0.2 ml saline

2

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • EF \< 45 %
  • NYHA 2 - 3

You may not qualify if:

  • Acute coronary syndrome within last 6 weeks.
  • Pregnancy
  • FEV1 \<1.0
  • Cancer
  • Any severe disease which could interfere with the treatment or the outcome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Heart Centre, Rigshospitalet University Hospital Copenhagen,

Copenhagen, 2100, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 25926562DERIVED

  • 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.

    PMID: 22980293DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Jens Kastrup, MD DMSc

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 20, 2008

First Posted

March 26, 2008

Study Start

September 1, 2008

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

DK(1)