Autologous Mesenchymal Stromal Cell Therapy in Heart Failure - Full Text View

Sponsor:	Rigshospitalet, Denmark
Information provided by (Responsible Party):	JKastrup, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00644410

Purpose

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.

Condition	Intervention	Phase
Congestive Heart Failure	Biological: Mesenchymal stromal cell Biological: Saline	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

Clinical and ejection fraction improvements [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Clinical and ejection fraction improvements [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Mesenchymal stromal cells	Biological: Mesenchymal stromal cell Mesenchymal stromal cells 20 - 40 mill.
Placebo Comparator: 2 Saline	Biological: Saline 12 injection with 0.2 ml saline

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644410

Contacts

Contact: Jens Kastrup, MD DMSc

+45 35452819

jens.kastrup@rh.regionh.dk

Locations

Denmark
The Heart Centre, Rigshospitalet University Hospital Copenhagen,	Recruiting
Copenhagen, Denmark, 2100
Principal Investigator: Jens Kastrup, MD

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Principal Investigator:

Jens Kastrup, MD DMSc

The Heart Centre, Rigshospitalet University Hospital Copenhagen, Denmark

More Information

No publications provided

Responsible Party:	JKastrup, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00644410 History of Changes
Other Study ID Numbers:	MSC heart failure
Study First Received:	March 20, 2008
Last Updated:	October 6, 2011
Health Authority:	Denmark: De Videnskabsetiske Komitéer for Region Hovedstaden.; Denmark: Danish Medicines Agency

Keywords provided by Rigshospitalet, Denmark:

heart failure
stem cell
mesenchymal stromal cell
mesenchymal stem cell

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012