CSCC_ASC Therapy in Patients With Severe Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Allogeneic adipose derived stem cells (CSCC_ASC)
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- 30 to 80 years of age
- Signed informed consent
- Chronic stable IHD
- HF (NYHA II-III)
- LVEF ≤45%
- Maximal tolerable angina and heart failure medication
- Medication unchanged two months prior to inclusion
- Angiography within six months of inclusion
- No option for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
- Patients who have had PCI or CABG within six months of inclusion must have a new angiography less than one month before inclusion or at least four months after the intervention to rule out early restenosis
- Patients cannot be included until six months after implantation of a cardiac resynchronisation therapy device
Exclusion Criteria:
- Heart Failure (NYHA I or IV)
- Acute coronary syndrome with elevation of CKMB or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion
- Other revascularisation treatment within four months of treatment
- Moderate to severe valvular disease or valvular disease with option for valvular surgery
- Diminished functional capacity for other reasons such as: coronary obstructive pulmonary disease (COPD) with forced expiratory volume (FEV) <1 L/min, moderate to severe claudication or morbid obesity
- Clinical significant anaemia, leukopenia, leukocytosis or thrombocytopenia
- Clinically significant abnormal prothrombin or partial thromboplastin time or anticoagulation treatment that cannot be paused during cell injections
- Patients with reduced immune response or treated with immunosuppressive medication
- History with malignant disease within five years of inclusion or suspected malignity - except treated skin cancer other than melanoma
- Pregnant women
- Other experimental treatment within four weeks of baseline tests
- Participation in another intervention trial
Sites / Locations
- 2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stem cell therapy
Arm Description
Treatment with direct intra-myocardial Injection of 100 million allogeneic adipose derived stem cells (CSCC_ASC) into the heart
Outcomes
Primary Outcome Measures
Safety: Number of patients with serious adverse events and development of tissue antibodies towards donor cells
Registration of number of patients with serious adverse events and development of tissue antibodies towards donor cells used for treatment in a 6 months follow-up period
Secondary Outcome Measures
Cardial efficacy: left ventricle end-systolic volume (LVESV, ml), left ventricular ejection fraction (LVEF, %), end-diastolic volume (ml) and end-systolic mass (g)
The secondary objectives are to demonstrate improvement in in left ventricle end-systolic volume (LVESV, ml), left ventricular ejection fraction (LVEF, %), end-diastolic volume (ml) and end-systolic mass (g) between baseline and follow-up
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02387723
Brief Title
CSCC_ASC Therapy in Patients With Severe Heart Failure
Official Title
Allogeneic Adipose Tissue-derived Stromal/Stem Cell Therapy in Patients With Ischemic Heart Disease and Heart Failure - a Safety Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
JKastrup
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The present aim is to perform at small clinical safety trial in heart failure patients with allogeneic adipose tissue derived mesenchymal stem cells.
Detailed Description
Patients with heart failure will be treated with culture expanded adipose tissue derived mesenchymal stem cells from healthy donors stored in nitrogen until use. The cells will be injected directly into the myocardium using the NOGA XP method.
The patients will be followed for 6 months for safety and efficacy registration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stem cell therapy
Arm Type
Experimental
Arm Description
Treatment with direct intra-myocardial Injection of 100 million allogeneic adipose derived stem cells (CSCC_ASC) into the heart
Intervention Type
Biological
Intervention Name(s)
Allogeneic adipose derived stem cells (CSCC_ASC)
Intervention Description
Culture expanded allogeneic adipose derive stem cells (CSCC_ASC)
Primary Outcome Measure Information:
Title
Safety: Number of patients with serious adverse events and development of tissue antibodies towards donor cells
Description
Registration of number of patients with serious adverse events and development of tissue antibodies towards donor cells used for treatment in a 6 months follow-up period
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Cardial efficacy: left ventricle end-systolic volume (LVESV, ml), left ventricular ejection fraction (LVEF, %), end-diastolic volume (ml) and end-systolic mass (g)
Description
The secondary objectives are to demonstrate improvement in in left ventricle end-systolic volume (LVESV, ml), left ventricular ejection fraction (LVEF, %), end-diastolic volume (ml) and end-systolic mass (g) between baseline and follow-up
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:
30 to 80 years of age
Signed informed consent
Chronic stable IHD
HF (NYHA II-III)
LVEF ≤45%
Maximal tolerable angina and heart failure medication
Medication unchanged two months prior to inclusion
Angiography within six months of inclusion
No option for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
Patients who have had PCI or CABG within six months of inclusion must have a new angiography less than one month before inclusion or at least four months after the intervention to rule out early restenosis
Patients cannot be included until six months after implantation of a cardiac resynchronisation therapy device
Exclusion Criteria:
Heart Failure (NYHA I or IV)
Acute coronary syndrome with elevation of CKMB or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion
Other revascularisation treatment within four months of treatment
Moderate to severe valvular disease or valvular disease with option for valvular surgery
Diminished functional capacity for other reasons such as: coronary obstructive pulmonary disease (COPD) with forced expiratory volume (FEV) <1 L/min, moderate to severe claudication or morbid obesity
Clinical significant anaemia, leukopenia, leukocytosis or thrombocytopenia
Clinically significant abnormal prothrombin or partial thromboplastin time or anticoagulation treatment that cannot be paused during cell injections
Patients with reduced immune response or treated with immunosuppressive medication
History with malignant disease within five years of inclusion or suspected malignity - except treated skin cancer other than melanoma
Pregnant women
Other experimental treatment within four weeks of baseline tests
Participation in another intervention trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Kastrup, Professor MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data can be shared for Scientific collaboration
Learn more about this trial
CSCC_ASC Therapy in Patients With Severe Heart Failure
We'll reach out to this number within 24 hrs