A Phase I Study Evaluating Autologous Bone Marrow Derived Mesenchymal Stromal for Crohn's Disease.

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.

Inclusion Criteria

- Men and women 18-65 years of age.

- Patient must have had CD for at least 3 months from the time of initial diagnosis.
The diagnosis of CD must have been confirmed by endoscopic and histological evidence.

- Patients must have active Crohn's disease as defined by a Crohns Disease Activity
Index (CDAI) score between >220 at screening and baseline.

- Patients should have no need for immediate surgery (i.e. due to obstruction,
strictures, active abscess or perforations ).

- Subjects must be refractory (defined as lack of response for at least 3 months) to
immunomodulators (including 6-mercaptopurine and azathioprine and methotrexate) or
anti-TNF therapy at present or some point in the course of their disease. Lack of
response is defined by failure to reduce the CDAI score by at least 70 points.

- The following medications will be allowed: mesalamine and prednisone (stable dose for
at least 2 weeks prior to enrollment).

- Subjects on anti TNF therapy will require a minimum of 4 weeks washout period prior
to screening.

- Subjects on non-steroidal analgesics require a minimum of 2 weeks washout period
prior to screening

- If female and of child-bearing age, patient must be non-pregnant, non-breastfeeding,
and use adequate contraception;

- Patient is willing to participate in the study and has signed the informed consent.