FindTrial
Sign In

Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia

Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00260338
Enrollment
31
Registered
2005-12-01
Start date
2005-12-31
Completion date
2009-07-31
Last updated
2013-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease, Myocardial Ischemia

Keywords

myocardial ischemia, stem cell, mesenchymal, myocardial perfusion

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.

Interventions

BIOLOGICALstem cell

mesenchymal stromal cell

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Improvement in myocardial perfusion measured by SPECT6 months after treatment

Secondary

MeasureTime frame
Safety6 months after treatment
Improvement in myocardial perfusion and function measured by PET and MR6 months after treatment
Exercise time6 months after treatment
Clinical angina status6 months after treatment

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026