Allogeneic adipose derived stromal cell therapy in patients with ischemic heart failure

Phase 1

• Conditions: Ischemic heart failure; MedDRA version: 20.0Level: LLTClassification code 10019285Term: Heart failure, unspecifiedSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-002511-26-DK
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-06
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.30 to 85 years of age
2.Written informed consent
3.Chronic stable ischemic heart disease
4.Symptomatic heart failure (NYHA II-III)
5.LVEF =40 % documented by echocardiography, CT or MRI obtained after up-titration of heart failure medication (if previously treated with cardiac resynchronisation at least 3 months after implantation)
6.Plasma NT-pro-BNP > 300 pg/ml (> 35 pmol/L) in sinus rhythm and plasma NT-pro-BNP > 422 pg/ml (> 49 pmol/L) in those patients with atrial fibrillation
7.Maximal tolerable heart failure medication
8.Heart failure medication unchanged two months prior to inclusion/signature of informed consent. Changes in diuretics are acceptable
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 and at least four months after the intervention to rule out early restenosis

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Exclusion criteria
1.NYHA I or IV heart failure
2.Implantation of a cardiac resynchronisation therapy device (CRT) within 3 months or Implantable Cardioverter Defibrillator (ICD) 1 month
3.Acute coronary syndrome with elevation of CKMB or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion
4.Other revascularisation treatment within four months of treatment
5.Moderate to severe aortic stenosis (valve area < 1.3 cm2) 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, severe arthrosis or severe pain from the musculoskeletal system, or morbid obesity
7.Clinically 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this trial is to investigate the treatment effect of repeat intra-myocardial injections of 100 million allogeneic CSCC_ASCs 6 months apart in patients with severe ischemic heart failure (=40%), in a randomized controlled study.<br>;Secondary Objective: Not applicable;Primary end point(s): The primary efficacy endpoint is change in left ventricle end-systolic volume (LVESV) at 12 months follow-up after first treatment.<br>;Timepoint(s) of evaluation of this end point: 12 months after (first) treatment