MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia (MyStromalCell Trial)

Phase 2

Completed

• Conditions: Chronic Ischemic Heart Disease
• Interventions: Biological: MSC; Biological: Saline

• Registration Number: NCT01449032
• Lead Sponsor: Rigshospitalet, Denmark

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 Timeline

• Study Start: 2010-04
• Study First Submitted: 2011-10-06
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-07
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-07
• Last Update Posted: 2014-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MSC	MSC	Adipose derived stem cells
Saline	Saline	-

Primary Outcome Measures

Name	Time	Method
Exercise test	6 months

Secondary Outcome Measures

Name	Time	Method
Clinical evaluation	6 months

Trial Locations

Locations (1)

Rigshospitalet University Hospital Copenhagen; 🇩🇰 Copenhagen, Denmark