Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Refractory Crohn*s Disease

Completed

Conditions: Crohn's Disease
morbus Crohn
10017969

Registration Number: NL-OMON31150

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

a) Men and women of at least 18 years of age.
b) Subject is willing to participate in the study and has signed the informed consent.
c) Subject 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 histologic evidence. If no previous confirmation of diagnosis is available or if previous diagnosis is not deemed conclusive, at time of screening endoscopy, histology should be performed to confirm diagnosis of CD.
d) Moderate to severe disease as defined by a CDAI score > 220, refractory to conventional medications and the affected ileocolonic site is endoscopically accessible.
e) At some time during the course of the subject*s Crohn's disease (CD), subject must have received both steroids and immunosuppressive agents (for example, azathioprine, 6-mercaptopurine, methotrexate, or infliximab) which did not result in an adequate response to treatment.
f) Subjects included in the study might be receiving 5-aminosalicylic acid, azathioprine, 6-mercaptopurine, methotrexate, prednisone, or any similar drug at the time of enrolment and is allowed to have a history of infliximab treatment, provided the following conditions are fulfilled:
* The dose of 5-ASA must have been stable for at least 4 weeks prior to enrolment.
* The dose of steroids must have been stable for at least 4 weeks prior to enrolment.
* The dose of immunosuppressants (for example azathioprine, 6MP, or methotrexate) must have been stable for at least 8 weeks prior to enrolment and the subject on therapy for at least three months prior to enrolment.
* The last dose of infliximab is > 8 weeks prior to enrolment.
g) No need for immediate surgery (obstruction, abscess).
h) Patients must be able to adhere to the study visit schedule and protocol requirements.
i) If female and of child-bearing age, subject must be non-pregnant, non-breastfeeding, and use adequate contraception.
j) Patients must be able to give informed consent and the consent must be obtained prior to any study procedure.

Exclusion Criteria

a) Patients with evidence of infection or abscesses.
b) Patients suffering from renal- or hepatic failure.
c) A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study.
d) Use of any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer.
e) Change in concomitant medication:
* 5-ASA and steroids should be on a stable dose > 4 weeks;
* Immunosuppressants (e.g. azathioprine, 6MP or methotrexate) should be on a stable dose > 8 weeks,
* infliximab or other anti-TNF antibody therapy should not be administered < 8 weeks.
f) Serious infections (such as pneumonia or pyelonephritis) in the previous 3 months. Less serious infections (such as acute upper respiratory tract infection [colds] or simple urinary tract infection) need not be considered exclusions at the discretion of the investigator.
g) Documented HIV infection.
h) Active hepatitis B, hepatitis C or TB.
i) Subjects who currently have or who have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
j) Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, cardiac, neurologic, or cerebral disease (including demyelinating diseases such as multiple sclerosis).
k) Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
l) History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly.
m) Known recent substance abuse (drug or alcohol).
n) Poor tolerability of venapuncture or lack of adequate venous access for required blood sampling during the study period.