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Completed

NCT Number: NCT01449032

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.

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Key information

Conditions

Chronic Ischemic Heart Disease

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rigshospitalet University Hospital Copenhagen

Copenhagen, 210, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MSC

Biological

No of cells after culture expansion

Other names: Adipose derived stem cells, Mesenchymal stromal cells, Mesenchymal stem cells

Saline

Biological

3 cc saline

Primary outcomes

  1. Exercise test

    Time frame: 6 months

Secondary outcomes

  1. Clinical evaluation

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Acronym: MyStromalCell

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Oct 7, 2011
Registry last updated
Jun 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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