Allogeneic Stem Cell Therapy in Heart Failure

NCT ID: NCT03092284

Last Updated: 2022-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2022-07-31

Brief 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.

Detailed 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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cardiology Stem Cell Centre Adipose Stem Cell (CSCC_ASC)

Allogeneic adipose derived stromal cells

Group Type: ACTIVE_COMPARATOR

Cardiology Stem Cell Centre Adipose Stem Cell (CSCC_ASC)

Intervention Type: BIOLOGICAL

Direct intramyocardial injection of CSCC\_ASC

Placebo

Saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Saline

Interventions

Cardiology Stem Cell Centre Adipose Stem Cell (CSCC_ASC)

Direct intramyocardial injection of CSCC\_ASC

Intervention Type: BIOLOGICAL

Placebo

Saline

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• 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

Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet

Copenhagen Ø, , Denmark

Countries

Denmark

References

Qayyum AA, Mouridsen M, Nilsson B, Gustafsson I, Schou M, Nielsen OW, Hove JD, Mathiasen AB, Jorgensen E, Helqvist S, Joshi FR, Johansen EM, Follin B, Juhl M, Hojgaard LD, Haack-Sorensen M, Ekblond A, Kastrup J. Danish phase II trial using adipose tissue derived mesenchymal stromal cells for patients with ischaemic heart failure. ESC Heart Fail. 2023 Apr;10(2):1170-1183. doi: 10.1002/ehf2.14281. Epub 2023 Jan 13.

Reference Type: DERIVED

PMID: 36638837 (View on PubMed)

Other Identifiers

CSCC_ASCII

Identifier Type: -

Identifier Source: org_study_id