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

This study is currently recruiting participants.
Verified October 2011 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
JKastrup, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01449032
First received: October 6, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted
  Purpose

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 Intervention Phase
Chronic Ischemic Heart Disease
 Biological: MSC
Biological: Saline
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia (MyStromalCell Trial)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Exercise test [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical evaluation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2010
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MSC
Adipose derived stem cells
 Biological: MSC
No of cells after culture expansion
Other Names:
  • Adipose derived stem cells
  • Mesenchymal stromal cells
  • Mesenchymal stem cells
Placebo Comparator: Saline Biological: Saline
3 cc saline
Other Name: Saline

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01449032

Contacts
Contact: Jens Kastrup, MD Professor +4535452819 jens.kastrup@rh.regionh.dk

Locations
Denmark
Rigshospitalet University Hospital Copenhagen Recruiting
Copenhagen, Denmark, 210
Contact: Jens Kastrup, MD Porfessor     +4535452819        
Principal Investigator: Jens Kastrup, MD Professor            
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Jens Kastrup, MD Professor Department of Cardiology, Rigshospitalet
  More Information

No publications provided

Responsible Party: JKastrup, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01449032     History of Changes
Other Study ID Numbers: MyStromalCell
Study First Received: October 6, 2011
Last Updated: October 6, 2011
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Keywords provided by Rigshospitalet, Denmark:
Patients

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Heart Diseases
Ischemia
Cardiovascular Diseases
 Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013