Ischaemic heart disease post MI MedDRA version: 20.0 Level: PT Classification code 10048858 Term: Ischaemic cardiomyopathy System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: LLT Classification code 10023024 Term: Ischaemic heart disease System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Product Name: Allogeneic Human Immunomodulatory Progenitor (iMP) cells (Heartcel)
Pharmaceutical Form: Injection
INN or Proposed INN: Heartcel
Other descriptive name: Immunomodulatory progenitor (iMP)
Sponsors
Cell Therapy Ltd (trading as Celixir)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • >= 15% left ventricular (LV) scar volume measured by Late Gadolinium Enhancement (LGE) Cardiovascular Magnetic Resonance (CMR). • LV Ejection fraction =2 and/or Canadian Cardiovascular Society (CCS) class angina >=2. • For women of child bearing potential (WOCBP): Negative (non-pregnant) beta-human chorionic gonadotropin (beta-hCG) blood test. 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Exclusion Criteria • Previous cardiac surgery. • Requirement for additional cardiac surgery (e.g. concomitant valve replacement). • Estimated Glomerular Filtration Rate (GFR) of 2. Note: Elevated INR due solely to warfarin (or similar medication) is NOT an exclusion criterion. • Increased mortality risk over a 12-month period due to comorbidity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of iMP cells administered by intramyocardial (IM) injection in individuals undergoing CABG surgery.;Secondary Objective: To assess the safety of iMP cells administered by IM injection in individuals undergoing CABG Surgery.;Primary end point(s): 1. Change in LV scar volume (as assessed by LGE-CMR) from baseline to 15 weeks ± 2 weeks post-operatively. ;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in CMR assessment of LVEF, LVEDVi, LVESVi, pattern of LV LGE, myocardial perfusion and myocardial strain from baseline to 15 weeks ± 2 weeks post-operatively. 2. MACE recorded at 30-days and 15 weeks ± 2 weeks post-surgery. MACE will be a composite of: 1. Cardiovascular death 2. Non-fatal MI 3. Non-fatal stroke 4. Unplanned cardiovascular hospitalisation 3. Major arrhythmic event at 30-days and 15 weeks ± 2 weeks post-surgery. 4. All-cause mortality at 30-days and 15 weeks ± 2 weeks post-surgery. 5. Change in Functional and Quality of Life (QoL) Assessments from baseline to 15 weeks ± 2 weeks post-operatively (4 QoL questionnaires): 1. NYHA classification 2. Kansas City Cardiomyopathy Questionnaire (KCCQ) 3. Minnesota Living with Heart Failure (MLHF) Score 4. EQ5D questionnaire 5. Length of hospital, intensive care unit, and high dependency unit admission 6. Change in blood biomarkers: Biomarkers to be measured before surgery, for 72 hours (12h, 24h, 48h, 72h) post-surgery, at 7 days, at 30 days and 15 weeks ± 2 weeks post-surgery. A. Standard Markers 1. Urea and Electrolytes 2. Liver function tests (LFTs) 3. Full blood count (FBC) B. Exploratory Markers 4. Uric acid 5. Lipid profile 6. High sensitivity (Hs)-C-reactive protein (CRP) 7. Hs-Troponin 8. N terminal (NT) pro brain natriuretic peptide (NT-proBNP) 9. Fibrotic and inflammatory pathways 10. Metabolomic and proteomic networks;Timepoint(s) of evaluation of this end point: Study Follow-Up: 15 weeks ± 2 weeks post-CABG surgery for efficacy and safety endpoints with up to 12 months post-surgery open label monitoring. | — |
Countries
United Kingdom
Contacts
Public ContactNigel Scott
Cell Therapy Ltd (trading as Celixir)
Outcome results
None listed