MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia (MyStromalCell Trial)
MyStromalCell
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2010
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 6, 2011
CompletedFirst Posted
Study publicly available on registry
October 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedJune 10, 2014
June 1, 2014
3.8 years
October 6, 2011
June 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Exercise test
6 months
Secondary Outcomes (1)
Clinical evaluation
6 months
Study Arms (2)
MSC
ACTIVE COMPARATORAdipose derived stem cells
Saline
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- CCS III - IV
- Coronary artery stenosis/occlusion not treatable with invasive procedures
- LVEF \> 40%
- ETT between 2 - 10 min
You may not qualify if:
- Valvular heart disease
- FEV1 \< 1
- Severe systemic disease
- Acute coronary syndrome \> 2 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rigshospitalet University Hospital Copenhagen
Copenhagen, 210, Denmark
Related Publications (2)
Qayyum AA, Mathiasen AB, Helqvist S, Jorgensen E, Haack-Sorensen M, Ekblond A, Kastrup J. Autologous adipose-derived stromal cell treatment for patients with refractory angina (MyStromalCell Trial): 3-years follow-up results. J Transl Med. 2019 Nov 12;17(1):360. doi: 10.1186/s12967-019-2110-1.
PMID: 31711513DERIVEDQayyum AA, Mathiasen AB, Mygind ND, Kuhl JT, Jorgensen E, Helqvist S, Elberg JJ, Kofoed KF, Vejlstrup NG, Fischer-Nielsen A, Haack-Sorensen M, Ekblond A, Kastrup J. Adipose-Derived Stromal Cells for Treatment of Patients with Chronic Ischemic Heart Disease (MyStromalCell Trial): A Randomized Placebo-Controlled Study. Stem Cells Int. 2017;2017:5237063. doi: 10.1155/2017/5237063. Epub 2017 Dec 3.
PMID: 29333165DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jens Kastrup, MD Professor
Department of Cardiology, Rigshospitalet
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 6, 2011
First Posted
October 7, 2011
Study Start
April 1, 2010
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
June 10, 2014
Record last verified: 2014-06