Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Charles S Cox, Jr., MD
CONTACT
Lead
Hope Biosciences LLC
With
This multicenter, prospective, randomized, double-blind, placebo-controlled pragmatic Phase 1/Phase 2a clinical study aims to investigate, through the collection of valid scientific evidence necessary to determine safety and effectiveness, the potential use of adiposederived allogenic MSCs to prevent progression of trauma-induced AKI. We hypothesize that infusing a total of 3 doses of MSCs over 72 hours at 24-hour intervals starting in patients with modified KDIGO Stage 2 or 3 AKI will prove to be safe and efficacious. Phase 1 of the study will include Cohort 1 (10 patients) and will confirm safety in this population with this cell formulation (cryopreserved and reanimated). Phase 2a of the study will include 60 patients (30 interventional, 30 placebo) and will look at duration of AKI at Stage 2 or higher (defined as proportion of patients with a duration of Stage 2 AKI more than 2 days after the start of treatment).
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
