CSCC_ASC Therapy in Patients With Severe Heart Failure

Heart Failure Clinical Trial

Official title:

Allogeneic Adipose Tissue-derived Stromal/Stem Cell Therapy in Patients With Ischemic Heart Disease and Heart Failure - a Safety Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02387723
• Other study ID #: CSCC_ASC1
• Status: Completed
• Phase: Phase 1
• First received: December 29, 2014
• Last updated: February 1, 2016
• Start date: December 2014
• Est. completion date: November 2015

Study information

• Verified date: February 2016
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The present aim is to perform at small clinical safety trial in heart failure patients with allogeneic adipose tissue derived mesenchymal stem cells.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Biological:
• Allogeneic adipose derived stem cells (CSCC_ASC)
Culture expanded allogeneic adipose derive stem cells (CSCC_ASC)

Locations

Country	Name	City	State
Denmark	2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
JKastrup

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months	Yes
Secondary	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	6 months	No