CSCC_ASC Therapy in Patients With Severe Heart Failure

NCT ID: NCT02387723

Last Updated: 2016-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-11-30

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stem cell therapy

Treatment with direct intra-myocardial Injection of 100 million allogeneic adipose derived stem cells (CSCC\_ASC) into the heart

Group Type: EXPERIMENTAL

Allogeneic adipose derived stem cells (CSCC_ASC)

Intervention Type: BIOLOGICAL

Culture expanded allogeneic adipose derive stem cells (CSCC\_ASC)

Interventions

Allogeneic adipose derived stem cells (CSCC_ASC)

Culture expanded allogeneic adipose derive stem cells (CSCC\_ASC)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. 30 to 80 years of age

2. Signed informed consent

3. Chronic stable IHD

4. HF (NYHA II-III)

5. LVEF ≤45%

6. Maximal tolerable angina and heart failure medication

7. Medication unchanged two months prior to inclusion

8. Angiography within six months of inclusion

9. No option for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)

10. 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

11. Patients cannot be included until six months after implantation of a cardiac resynchronisation therapy device

Exclusion Criteria

1. Heart Failure (NYHA I or IV)

2. Acute coronary syndrome with elevation of CKMB or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion

3. Other revascularisation treatment within four months of treatment

4. Moderate to severe valvular disease or valvular disease with option for valvular surgery

5. 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

6. Clinical significant anaemia, leukopenia, leukocytosis or thrombocytopenia

7. Clinically significant abnormal prothrombin or partial thromboplastin time or anticoagulation treatment that cannot be paused during cell injections

8. Patients with reduced immune response or treated with immunosuppressive medication

9. History with malignant disease within five years of inclusion or suspected malignity - except treated skin cancer other than melanoma

10. Pregnant women

11. Other experimental treatment within four weeks of baseline tests

12. Participation in another intervention trial

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

JKastrup

OTHER

Sponsor Role: lead

Responsible Party

JKastrup

Professor Chief Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jens Kastrup, Professor MD

Role: STUDY_DIRECTOR

Rigshospitalet, Denmark

Locations

2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

CSCC_ASC1

Identifier Type: -

Identifier Source: org_study_id