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

Completed · Phase 1

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT01659762

Run by

Emory University

People needed

16

Starts

2012-07-01

Last updated by the study team

2016-10-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Emory University — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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