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EXCELLENT
NCT02669810Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2016
- Primary completion
- Mar 2024
- Countries
- 2
- Sponsor
- CellProthera
- Modality
- Stem Cell Therapies
- Conditions
- acute myocardial infarction (AMI)
01
Overview
Phase 2, randomised, open-label trial in acute myocardial infarction (AMI) comparing PROTHERACYTES with Standard of Care (2 arms). Primary endpoint: Major Adverse Cardiac Events at 6 months. Started Feb 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
PROTHERACYTES
PROTHERACYTES endocardiac injections + Standard Treatment for CHF post AMI
Standard of Care
Standard Treatment for CHF post AMI
03
Who it enrols
Adult patients with acute myocardial infarction within 1 week of first symptoms, LVEF < 50%, and akinetic/dyskinetic segments, excluding those with severe valve disease, prior CABG, severe renal impairment, or active infections.
04
Endpoints
Primary
Major Adverse Cardiac Events
Secondary
Left Ventricle End Systolic Volume index
Viability improvement of the infarcted segment(s)
05
Results
Not all primary endpoints met
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