Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JKastrup, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00260338
First received: November 29, 2005
Last updated: May 30, 2013
Last verified: May 2013
  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
Biological: stem cell
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Improvement in myocardial perfusion measured by SPECT [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 6 months after treatment ] [ Designated as safety issue: Yes ]
  • Improvement in myocardial perfusion and function measured by PET and MR [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
  • Exercise time [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
  • Clinical angina status [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: December 2005
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mesenchymal stromal cell
Mesenchymal stromal cell
Biological: stem cell
mesenchymal stromal cell

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Rigshospitalet, Denmark

Additional 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
Study First Received: November 29, 2005
Last Updated: May 30, 2013
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
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014