MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia (MyStromalCell Trial) (MyStromalCell)
Primary Purpose
Chronic Ischemic Heart Disease
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
MSC
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Ischemic Heart Disease focused on measuring Patients
Eligibility 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
Sites / Locations
- Rigshospitalet University Hospital Copenhagen
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
MSC
Saline
Arm Description
Adipose derived stem cells
Outcomes
Primary Outcome Measures
Exercise test
Secondary Outcome Measures
Clinical evaluation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01449032
Brief Title
MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia (MyStromalCell Trial)
Acronym
MyStromalCell
Official Title
MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia (MyStromalCell Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Ischemic Heart Disease
Keywords
Patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MSC
Arm Type
Active Comparator
Arm Description
Adipose derived stem cells
Arm Title
Saline
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
MSC
Other Intervention Name(s)
Adipose derived stem cells, Mesenchymal stromal cells, Mesenchymal stem cells
Intervention Description
No of cells after culture expansion
Intervention Type
Biological
Intervention Name(s)
Saline
Intervention Description
3 cc saline
Primary Outcome Measure Information:
Title
Exercise test
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Clinical evaluation
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Kastrup, MD Professor
Organizational Affiliation
Department of Cardiology, Rigshospitalet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet University Hospital Copenhagen
City
Copenhagen
ZIP/Postal Code
210
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
31711513
Citation
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.
Results Reference
derived
PubMed Identifier
29333165
Citation
Qayyum 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.
Results Reference
derived
Learn more about this trial
MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia (MyStromalCell Trial)
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