Skip to main content
OpenTrials
Completed

NCT Number: NCT00260338

Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myocardial Ischemia Cardiovascular Diseases Coronary Disease Coronary Heart Disease Heart Diseases Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stem cell

Biological

mesenchymal stromal cell

Primary outcomes

  1. Improvement in myocardial perfusion measured by SPECT

    Time frame: 6 months after treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Dec 1, 2005
Registry last updated
May 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.