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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)

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

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

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

NCT ID

NCT02387723

First Posted

December 29, 2014

Last Updated

February 1, 2016

Sponsor

JKastrup

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

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

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

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