Crohn's Disease Clinical Trial
Official title:
A Phase I Study Evaluating Safety and Tolerability of Autologous Bone Marrow Derived Mesenchymal Stromal (MSC) Cells in Adults With Moderate to Severe Crohn's Disease.
In this Phase I trial the investigators intend to show safety and tolerability of autologous MSC, expanded using a non-xenogeneic, human component platelet lysate expansion media. Fresh, non cryopreserved, autologous MSCs will delivered intravenously as a single bolus dose in a dose escalation phase I study. The investigators intend to test whether the product is clinically safe in adults (18-65 years old) with CD and to determine maximal deliverable dose. Secondary endpoint will monitor effectiveness using CDAI as an endpoint.
EPIC MSC/IBD is made up of autologous marrow-derived mesenchymal stromal cells ex vivo
expanded numerically for approximately 14 days using pooled human Platelet Lysate (phPL),
harvested on the day of infusion, washed and suspended at a concentration of 4 million
cells/ml in Plasmalyte A with 0.5% human serum albumin. This is a phase I dose-escalation,
open label, non-randomized, non-placebo controlled, single group assignment study to
evaluate the safety and tolerability of a single intravenous infusion of EPIC MSC2011-001.
EPIC EPIC MSC/IBD will be infused intravenously and will be administered at one of three
dose levels: (Tier 1) 2 million cells/kg patient body weight; (Tier 2) 5 million cells/kg,
and (Tier 3) 10 million cells/kg. This Phase I clinical trial will enroll 16-20 subjects
with moderate to severe Crohn's. The duration of this study for each patient is 12 weeks.
The investigators anticipate that this study will be completed within 2 years of
commencement.
Primary objective: To describe and compare the safety and tolerability of a single infusion
of fresh autologous bone marrow derived Mesenchymal stromal cells infused to patients with
moderate to severe Crohn's disease.
Secondary objective: Efficacy of autologous bone marrow derived Mesenchymal stromal cells
infusion to patients with moderate to severe Crohn's disease as assessed through disease
activity index, and quality of life index.
Safety variables:Adverse events (AEs),Laboratory parameters (hematology, biochemistry,
urinalysis), Vital signs.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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