Allogeneic Stem Cell Therapy in Heart Failure

Heart Failure Clinical Trial

— CSCC_ASCII  

Official title:

Allogeneic Adipose Tissue-derived Stromal/Stem Cell Therapy in Patients With Ischemic Heart Disease and Heart Failure: A Phase II Danish Multicentre Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03092284
• Other study ID #: CSCC_ASCII
• Status: Completed
• Phase: Phase 2
• Start date: September 2015
• Est. completion date: July 2022

Study information

• Verified date: September 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present aim is to perform at clinical double-blind placebo-controlled Cardiology Stem Cell Centre - Adipose Stem Cells (CSCC_ASC) study in heart failure patients to investigate the regenerative capacity of the CSCC_ASC treatment.

Description:

The primary objective is to investigate the regenerative capacity of direct intra-myocardial injection of 100 mio. allogeneic CSCC_ASCs in patients with reduced left ventricular Ejection Fraction (EF) (≤45%) and heart failure in a double-blind placebo-controlled design. A total of 81 patients with will be enrolled in the study and treated in a 2:1 randomization with either CSCC_ASC or placebo (saline). The primary endpoint is change in left ventricle end-systolic volume (LVESV) at 6 months follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: July 2022
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 30 to 80 years of age

2. Signed informed consent

3. Chronic stable ischemic heart disease

4. Symptomatic heart failure - New York Heart Association (NYHA) class II-III

5. EF =45%

6. Plasma NT-pro-BNP > 300 pg/ml (> 35 pmol/L) in sinus rhythm and plasma NT-pro-BNP > 422 pg/ml (> 450 pmol/L) in patients with atrial fibrillation

7. Maximal tolerable heart failure medication

8. Medication unchanged two months prior to 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 three 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 creatine kinase (CK) isoenzyme MB (CKMB) or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion

3. Other revascularisation treatment within four months of treatment

4. If clinically indicated the patient should have a coronary angiography before inclusion

5. Moderate to severe aortic stenosis (valve area < 1.3 mm2) or valvular disease with option for surgery.

6. Diminished functional capacity for other reasons such as: obstructive pulmonary disease (COPD) with forced expiratory volume (FEV) <1 L/min, moderate to severe claudication or morbid obesity

7. Clinical significant anaemia (haemoglobin < 6 mmol/L), leukopenia (leucocytes < 2 109/L), leucocytosis (leucocytes >14 109/L) or thrombocytopenia (thrombocytes < 50 109/L)

8. Anticoagulation treatment that cannot be paused during cell injections

9. Patients with reduced immune response

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

11. Pregnant women

12. Other experimental treatment within four weeks of baseline tests

13. Participation in another intervention trial

Related Conditions & MeSH terms

• Heart Failure

Intervention

Biological:
• Cardiology Stem Cell Centre Adipose Stem Cell (CSCC_ASC)
Direct intramyocardial injection of CSCC_ASC
• Placebo
Saline

Locations

Country	Name	City	State
Denmark	Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet	Copenhagen Ø

Sponsors (1)

Lead Sponsor	Collaborator
JKastrup

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in left ventricle end-systolic volume (LVESV) from base line to 6 months follow-up measured by echocardiography and computerized tomography	change in left ventricle end-systolic volume (LVESV) from base line to 6 months follow-up measured by echocardiography and computerized tomography	6 months
Secondary	Incidence of Treatment-Emergent Adverse Events	Safety is evaluated by the incidence and severity of serious adverse events and suspected unrelated serious adverse events at 12 months follow-up	12 months
Secondary	Efficacy left ventricle	change in left ventricle ejection fraction (EF) measured by echocardiography and computerized tomography	6 months
Secondary	Efficacy clinical function assessed by change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 6 months follow-up	change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 6 months follow-up	6 months
Secondary	Efficacy clinical function assessed by change in Seattle Angina Questionnaire and 6 min walking test from baseline to 6 months follow-up	change in Seattle Angina Questionnaire and 6 min walking test from baseline to 6 months follow-up	6 months
Secondary	Efficacy clinical function assessed by change in 6 min walking test from baseline to 6 months follow-up	change in 6 min walking test from baseline to 6 months follow-up	6 months
Secondary	Efficacy clinical function assessed by change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 12 months follow-up	change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 12 months follow-up	12 months
Secondary	Efficacy clinical function assessed by change in Seattle Angina Questionnaire and 6 min walking test from baseline to 12 months follow-up	change in Seattle Angina Questionnaire and 6 min walking test from baseline to 12 months follow-up	12 months
Secondary	Efficacy clinical function assessed by change in 6 min walking test from baseline to 12 months follow-up	change in 6 min walking test from baseline to 12 months follow-up	12 months