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Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00260338
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : May 31, 2013
Sponsor:
Information provided by (Responsible Party):
JKastrup, Rigshospitalet, Denmark

Tracking Information
First Submitted Date  ICMJE November 29, 2005
First Posted Date  ICMJE December 1, 2005
Last Update Posted Date May 31, 2013
Study Start Date  ICMJE December 2005
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2013)
Improvement in myocardial perfusion measured by SPECT [ Time Frame: 6 months after treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 29, 2005)
Improvement in myocardial perfusion measured by SPECT
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2013)
  • Safety [ Time Frame: 6 months after treatment ]
  • Improvement in myocardial perfusion and function measured by PET and MR [ Time Frame: 6 months after treatment ]
  • Exercise time [ Time Frame: 6 months after treatment ]
  • Clinical angina status [ Time Frame: 6 months after treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2005)
  • Safety
  • Improvement in myocardial perfusion and function measured by PET and MR
  • Exercise time
  • Clinical angina status
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia
Official Title  ICMJE Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Myocardial Ischemia
  • Coronary Heart Disease
Intervention  ICMJE Biological: stem cell
mesenchymal stromal cell
Study Arms  ICMJE Active Comparator: Mesenchymal stromal cell
Mesenchymal stromal cell
Intervention: Biological: stem cell
Publications * Mathiasen AB, Haack-Sørensen M, Jørgensen E, Kastrup J. Autotransplantation of mesenchymal stromal cells from bone-marrow to heart in patients with severe stable coronary artery disease and refractory angina--final 3-year follow-up. Int J Cardiol. 2013 Dec 10;170(2):246-51. doi: 10.1016/j.ijcard.2013.10.079. Epub 2013 Oct 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 4, 2011)
31
Original Enrollment  ICMJE
 (submitted: November 29, 2005)
40
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00260338
Other Study ID Numbers  ICMJE Jens Kastrup
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party JKastrup, Rigshospitalet, Denmark
Study Sponsor  ICMJE Rigshospitalet, Denmark
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jens Kastrup, MD DMSc Rigshospitalet, Denmark
PRS Account Rigshospitalet, Denmark
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP