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enrolling by invitation

Open-label Extension of the HOPE-2 Trial

key information

study id #: NCT04428476

condition: Duchenne Muscular Dystrophy

status: enrolling by invitation

purpose:

This Phase 2, multi-center, open-label extension trial will provide CAP-1002 to subjects that were enrolled in the HOPE-2 trial and completed 12 months of follow-up. The trial will explore the safety and efficacy of four intravenous administrations of CAP-1002, each separated by three months. Subjects will undergo a targeted screening during a 30-day screening period, eligible subjects will then undergo baseline safety and efficacy assessments on Day 1 prior to their first infusion of CAP-1002.

Subjects will complete trial assessments at Screening; Day 1; Months 3, 6, 9 and 12. Safety and efficacy assessments will be conducted prior to CAP-1002 administration at the Day 1, Months 3, 6 and 9 trial visits, unless otherwise indicated.

All CAP-1002 infusions will be conducted in an outpatient setting at the investigative site on Day 1 and Months 3, 6 and 9. Subjects will be observed in the outpatient setting for at least two hours post infusion and then discharged the same day if medically cleared by the site Investigator.

intervention: CAP-1002

mechanism of action: Cardiac progenitor cells to promote cellular regeneration

results: https://clinicaltrials.gov/ct2/show/results/NCT04428476

last updated: October 21, 2020