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

June 7, 2014 updated by: JKastrup, Rigshospitalet, Denmark

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 210
        • Rigshospitalet University Hospital Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Saline
Biological: Saline
3 cc saline
ACTIVE_COMPARATOR: MSC
Adipose derived stem cells
Biological: MSC
No of cells after culture expansion
Other Names:
  • Mesenchymal stem cells
  • Mesenchymal stromal cells
  • Adipose derived stem cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Exercise test
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical evaluation
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Jens Kastrup, MD Professor, Department of Cardiology, Rigshospitalet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

October 6, 2011

First Submitted That Met QC Criteria

October 6, 2011

First Posted (ESTIMATE)

October 7, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 10, 2014

Last Update Submitted That Met QC Criteria

June 7, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MyStromalCell

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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