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Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia

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ClinicalTrials.gov Identifier: NCT00260338
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : May 31, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Myocardial Ischemia Coronary Heart Disease Biological: stem cell Phase 1 Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia
Study Start Date : December 2005
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Mesenchymal stromal cell
Mesenchymal stromal cell
Biological: stem cell
mesenchymal stromal cell


Outcome Measures

Primary Outcome Measures :
  1. Improvement in myocardial perfusion measured by SPECT [ Time Frame: 6 months after treatment ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: 6 months after treatment ]
  2. Improvement in myocardial perfusion and function measured by PET and MR [ Time Frame: 6 months after treatment ]
  3. Exercise time [ Time Frame: 6 months after treatment ]
  4. Clinical angina status [ Time Frame: 6 months after treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: JKastrup, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00260338     History of Changes
Other Study ID Numbers: Jens Kastrup
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: May 31, 2013
Last Verified: May 2013

Keywords provided by JKastrup, Rigshospitalet, Denmark:
myocardial ischemia
stem cell
mesenchymal
myocardial perfusion

Additional relevant MeSH terms:
Heart Diseases
Ischemia
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases