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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
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Ischemic Heart Disease focused on measuring Patients

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 6, 2011
Last Updated
June 7, 2014
Sponsor
Rigshospitalet, Denmark
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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

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

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