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

Launched by EMORY UNIVERSITY · Aug 7, 2012

Keywords

ClinConnect Summary

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 admini...

Gender

ALL

Eligibility criteria

• • 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.