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Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia

Primary Purpose

Myocardial Ischemia, Coronary Heart Disease

Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
stem cell
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Ischemia focused on measuring myocardial ischemia, stem cell, mesenchymal, myocardial perfusion

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiovascular Lab. 2014, The Heart Centre, Rigshospitalet, Blegdamcvej 9

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Mesenchymal stromal cell

Arm Description

Mesenchymal stromal cell

Outcomes

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

Full Information

First Posted
November 29, 2005
Last Updated
May 30, 2013
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00260338
Brief Title
Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia
Official Title
Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia, Coronary Heart Disease
Keywords
myocardial ischemia, stem cell, mesenchymal, myocardial perfusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesenchymal stromal cell
Arm Type
Active Comparator
Arm Description
Mesenchymal stromal cell
Intervention Type
Biological
Intervention Name(s)
stem cell
Intervention Description
mesenchymal stromal cell
Primary Outcome Measure Information:
Title
Improvement in myocardial perfusion measured by SPECT
Time Frame
6 months after treatment
Secondary Outcome Measure Information:
Title
Safety
Time Frame
6 months after treatment
Title
Improvement in myocardial perfusion and function measured by PET and MR
Time Frame
6 months after treatment
Title
Exercise time
Time Frame
6 months after treatment
Title
Clinical angina status
Time Frame
6 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Kastrup, MD DMSc
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Lab. 2014, The Heart Centre, Rigshospitalet, Blegdamcvej 9
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
24211066
Citation
Mathiasen AB, Haack-Sorensen M, Jorgensen 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.
Results Reference
derived

Learn more about this trial

Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia

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