A Phase IIB Study of the Efficacy and Safety of Intramyocardial Injection of Allogeneic Human Immunomodulatory Progenitor (iMP) cells in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery.
- Conditions
- Ischaemic heart disease post MIMedDRA version: 20.0Level: PTClassification code 10048858Term: Ischaemic cardiomyopathySystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: LLTClassification code 10023024Term: Ischaemic heart diseaseSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2017-000516-42-GB
- Lead Sponsor
- Cell Therapy Ltd (trading as Celixir)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
• >= 15% left ventricular (LV) scar volume measured by Late Gadolinium Enhancement (LGE) Cardiovascular Magnetic Resonance (CMR).
• LV Ejection fraction <= 50%. • Ischaemic heart disease in which CABG is the recommended revascularisation strategy.
• Age range: 18 years of age and over with no history of congenital cardiac anomalies (men and women).
• Able to provide written informed consent (including willingness to have two CMRs).
• New York Heart Association (NYHA) class >=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
• Previous cardiac surgery.
• Requirement for additional cardiac surgery (e.g. concomitant valve replacement).
• Estimated Glomerular Filtration Rate (GFR) of <30mL/min.
• Contraindication to LGE-CMR.
• Clinical history of malignancy within the last 5 years.
• Comorbidities likely to influence the safety of performing the protocol.
• Liver disease including Alanine Transaminase (ALT) 3 times or more the upper limit of normal.
• Low platelet count (<100,000) platelets per microliter of blood.
• Evidence of coagulopathy – International Normalised Ratio (INR) >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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>;Timepoint(s) of evaluation of this end point: 6 months
- Secondary Outcome Measures
Name Time Method