MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia (MyStromalCell Trial) (MyStromalCell)
|ClinicalTrials.gov Identifier: NCT01449032|
Recruitment Status : Completed
First Posted : October 7, 2011
Last Update Posted : June 10, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Ischemic Heart Disease||Biological: MSC Biological: Saline||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia (MyStromalCell Trial)|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
Active Comparator: MSC
Adipose derived stem cells
No of cells after culture expansion
|Placebo Comparator: Saline||
3 cc saline
- Exercise test [ Time Frame: 6 months ]
- Clinical evaluation [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01449032
|Rigshospitalet University Hospital Copenhagen|
|Copenhagen, Denmark, 210|
|Principal Investigator:||Jens Kastrup, MD Professor||Department of Cardiology, Rigshospitalet|