NCT00260338

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

May 31, 2013

Status Verified

May 1, 2013

Enrollment Period

3.6 years

First QC Date

November 29, 2005

Last Update Submit

May 30, 2013

Conditions

Myocardial IschemiaCoronary Heart Disease

Keywords

myocardial ischemiastem cellmesenchymalmyocardial perfusion

Outcome Measures

Primary Outcomes (1)

  • Improvement in myocardial perfusion measured by SPECT

    6 months after treatment

Secondary Outcomes (4)

  • Safety

    6 months after treatment

  • Improvement in myocardial perfusion and function measured by PET and MR

    6 months after treatment

  • Exercise time

    6 months after treatment

  • Clinical angina status

    6 months after treatment

Study Arms (1)

Mesenchymal stromal cell

ACTIVE COMPARATOR

Mesenchymal stromal cell

Biological: stem cell

Interventions

stem cellBIOLOGICAL

mesenchymal stromal cell

Mesenchymal stromal cell

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 24211066DERIVED

MeSH Terms

Conditions

Myocardial IschemiaCoronary Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Jens Kastrup, MD DMSc

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 29, 2005

First Posted

December 1, 2005

Study Start

December 1, 2005

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

May 31, 2013

Record last verified: 2013-05

Locations

DK(1)