A Phase 2 interventional study of MSC and Saline in Chronic Ischemic Heart Disease, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-06-10.
Sponsored by Rigshospitalet, Denmark · Phase 2, Interventional, and Treatment
Coronary artery disease (CAD) is the most common cause of death and a major cause of hospital admissions for acute chest pain. In spite of improved treatments still many patients with CAD have daily attacks of severe chest pain and severely reduced life quality.
The investigators have established a double-blind placebo-controlled trial in patients with CAD to test efficacy and safety of treatment with adipose derived stem cells to improve perfusion in the heart muscle and exercise capacity, and reduce the patient's symptoms.
In an open single centre pilot study we have evaluated the safety and efficacy of MSC treatment to improve heart muscle perfusion in patients with chronic CAD. Patients treated with MSCs had significant increased exercise capacity, reduction in angina, angina attacks and medication and in life quality at 6 months follow-up. For all the parameters there was a tendency towards improved outcome with increasing number of cells. The treatment with MSCs was safe.
The investigators have now established a double-blind placebo-controlled trial in patients with CAD to test efficacy and safety of treatment with MSCs to improve perfusion in the heart muscle and exercise capacity, and reduce the patient's symptoms.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 60 is below the median of 100 across 1,779 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Adipose derived stem cells
Biological: MSC
Biological: Saline
No of cells after culture expansion
Also known as: Adipose derived stem cells, Mesenchymal stromal cells, Mesenchymal stem cells
3 cc saline
Exercise test
Time frame: 6 months
Clinical evaluation
Time frame: 6 months
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Rigshospitalet, Denmark