Crohn's Disease morbus Crohn
Conditions
Interventions
MSC infusion: two doses of 2.0 x 106 MSCs per kilogram body weight,
intravenously, 7 days apart.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Safety: rate of (serious) adverse events in the study population 2 Feasibility: determination of the number of expanded MSCs in relation to the amount of bone marrow collected, number of passages required and time to reach study target doses. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Induction of clinical response (reduction of CDAI > 70) or clinical remission (CDAI below 150) at six weeks. 2 Mucosal healing at six weeks. 3 Biological response (CRP reduction) at six weeks. | — |
Countries
Netherlands
Outcome results
None listed