Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia - Full Text View

Sponsor:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00260338

Purpose

Mesenchymal stem cells from the bone marrow can be stimulated to differentiate into endothelial cells and participate in the development of new blood vessels in ischemic tissue.

The aim of the study is in a phase I/II safety and efficacy study to evaluate the clinical effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial ischemia.

Condition	Intervention	Phase
Myocardial Ischemia Coronary Heart Disease	Drug: stem cell	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

Improvement in myocardial perfusion measured by SPECT

Secondary Outcome Measures:

Safety
Improvement in myocardial perfusion and function measured by PET and MR
Exercise time
Clinical angina status

Estimated Enrollment:	40
Study Start Date:	December 2005
Study Completion Date:	February 2009

Detailed Description:

Mesenchymal stem cells from the bone marrow can be stimulated to differentiate into endothelial cells and participate in the development of new blood vessels in ischemic tissue.

The aim of the study is in a phase I/II safety and efficacy study to evaluate the clinical effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial ischemia.

4o patients with reversible ischemia on a SPECT will be treated with direct intramyocardial injections of autologous isolated and expanded mesenchymal stem cells.Clinical and objective evaluations will be performed at baseline and during 12 months follow-up.

Eligibility

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

Criteria

Inclusion Criteria:

Age 30 to 80 years Reversible ischemia on a stress SPECT Angina pectoris CCS class >_ 2 Reduced exercise time < 10 min No further revascularization options

Exclusion Criteria:

Pregnant Present or history of cancer Proliferative retinopathy Systemic severe disease LVEF < 25 % NYHA > II

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260338

Locations

Denmark
Cardiovascular Lab. 2014, The Heart Centre, Rigshospitalet, Blegdamcvej 9
Copenhagen, Denmark, 2100

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Principal Investigator:

Jens Kastrup, MD DMSc

Rigshospitalet, Denmark

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00260338 History of Changes
Other Study ID Numbers:	Jens Kastrup
Study First Received:	November 29, 2005
Last Updated:	July 7, 2009
Health Authority:	United States: Food and Drug Administration; Denmark: De Videnskabsetiske Komiteer for Københavns og Frederiksberg Kommuner; Denmark: Danish Medicines Agency

Keywords provided by Rigshospitalet, Denmark:

myocardial ischemia
stem cell
mesenchymal
myocardial perfusion

Additional relevant MeSH terms:

Coronary Artery Disease
Coronary Disease
Heart Diseases
Ischemia
Myocardial Ischemia

Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 01, 2010