Chronic Ischemic Heart Disease Clinical Trial
Official title:
MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia (MyStromalCell Trial)
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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