Stem cell therapy in heart failure

• Register: EUCTR
• Last refreshed on: 13 June 2016
• Main ID: EUCTR2015-002929-19-DK
• Date of registration: 07/04/2016
• Prospective Registration: Yes
• Primary sponsor: Department of Cardiology, Rigshospitalet
• Public title: Stem cell therapy in heart failure
• Scientific title: Stem Cell therapy in IschEmic Non-treatable Cardiac disease - SCIENCE - SCIENCE
• Date of first enrolment: 15/04/2016
• Target sample size: 138
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002929-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Denmark, Germany, Netherlands, Poland, Slovenia

Contacts

• Name: Jens Kastrup
• Affiliation: Department of Cardiology, 2014, Rigshospitalet

• Name: Jens Kastrup
• Affiliation: Department of Cardiology, 2014, Rigshospitalet

Key inclusion & exclusion criteria

Inclusion criteria:
Inclusion criteria:
1. 30 to 80 years of age
2. Signed informed consent
3. Chronic stable ischemic heart disease
4. Heart failure (NYHA II-III)
5. LVEF =45%
6. Plasma NT-pro-BNP > 300 pg/ml (> 35 pmol/L) in sinus rhythm
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
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 79

Exclusion criteria:
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. If clinically indicated the patient should have a coronary angiography
before inclusion
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 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Ischemic heart disease and heart failure
MedDRA version: 19.0 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

Product Name: Allogeneic adipose tissue-derived stromal cells
Product Code: CSCC_ASC
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CSCC_ASC
Current Sponsor code: SCIENCE
Other descriptive name: Ex vivo cultured human mesenchymal stem cells
Concentration unit: million organisms/ml million organisms/millilitre
Concentration type: equal
Concentration number: 110 mill in 5 ml-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intracardiac use

Primary Outcome(s)

Secondary Objective: Improvement in cardiac function and clinical symptoms

Timepoint(s) of evaluation of this end point: 6 months after treatment

Main Objective: To perform at clinical double-blind placebo-controlled CSCC_ASC
multicentre study in heart failure patients to investigate the
regenerative capacity of the CSCC_ASC treatment.

Primary end point(s): The primary endpoint is change in left ventricle end-systolic volume
(LVESV) at 6 months follow-up between CSCC_ASC and placebo patients

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1 and 6 months after treatment and 1, 2 and 3 years

Secondary end point(s): The secondary endpoints are safety evaluated by development of
allogeneic antibodies and laboratory safety measurements 1 and 6
months after treatment and changes in left ventricular ejection fraction
(LVEF), end-diastolic volume and myocardial mass at 6 months followup.
The changes in left ventricle function will be measured by echocardiography
(ECHO) or computed tomography (CT). Other secondary endpoints are changes in NYHA, CCS,
Kansas City Cardiomyopathy Questionnaire (KCCQ), 6 min walking test and NT-pro-
BNP. In addition, safety of allogeneic CSCC_ASCs with respect to
incidence and severity of serious adverse events and suspected
unrelated serious adverse events will be evaluated at 12 months followup.
A combined endpoint of
1. death, hospitalization for worsening heart failure including inserting
of a bi-ventricular pacemaker, hospitalization because of ventricular
tachycardia or fibrillation and increased heart failure medical treatment
1, 2 and 3 years after treatment
2. death, hospitalization for any cardiovascular reason, hospitalization
for worsening heart failure including inserting of a bi-ventricular
pacemaker, hospitalization because of ventricular tachycardia or
fibrillation and increased heart failure medical treatment 1, 2 and 3
years after treatment.

Secondary ID(s)

SCIENCE

Source(s) of Monetary Support

Rigshospitalet