MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia (MyStromalCell Trial)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Exercise test
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 30 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •CCS III - IV
- •Coronary artery stenosis/occlusion not treatable with invasive procedures
- •LVEF > 40%
- •ETT between 2 - 10 min
Exclusion Criteria
- •Valvular heart disease
- •FEV1 < 1
- •Severe systemic disease
- •Acute coronary syndrome > 2 months
Arms & Interventions
MSC
Adipose derived stem cells
Intervention: MSC (Biological)
Saline
Intervention: Saline (Biological)
Outcomes
Primary Outcomes
Exercise test
Time Frame: 6 months
Secondary Outcomes
- Clinical evaluation(6 months)
Investigators
JKastrup
Professor
Rigshospitalet, Denmark