Crohn disease. Crohn disease, unspecified
Conditions
Interventions
Phase 1/2 Clinical Trial.
Intravenous infusion autologous Bone Marrow-derived Mesenchymal Stem Cells (MSCs) for refractory Crohn’s disease.
Two dose infusions of 0.5 to 2 ×106 cell/kg with a week in
Treatment - Other
Phase 1/2 Clinical Trial.
Intravenous infusion autologous Bone Marrow-derived Mesenchymal Stem Cells (MSCs) for refractory Crohn’s disease.
Two dose infusions of 0.5 to 2 ×106 cell/kg with a week
Sponsors
Vice Chancellor for Research and Technology University, Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria:Patients at least 18 years of age; Crohn’s Disease Activity Index (CDAI) score between 220 and 450; Colonoscopy performe at baseline to confirm disease activity; Patients have to be refractory to the standard treatment options for Crohn’s disease; such as: steroids, immunosuppressive agents (eg, azathioprine, 6-mercaptopurine or methotrexate) or anti-TNF therapy. Exclusion criteria:History of malignancy during the course of treatment or during the last 5 years.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Interleukin 23 level. Timepoint: Before intervention, Three months after intervention, six months after intervention. Method of measurement: ELISA, Pg/ml.;IFN-? level. Timepoint: Before intervention, Three months after intervention, six months after intervention. Method of measurement: ELISA, Pg/ml.;Interleukin 10 level. Timepoint: Before intervention, Three months after intervention, six months after intervention. Method of measurement: ELISA, Pg/ml.;Interleukin 4 level. Timepoint: Before intervention, Three months after intervention, six months after intervention. Method of measurement: ELISA, Pg/ml.;TGF-ß level. Timepoint: Before intervention, Three months after intervention, six months after intervention. Method of measurement: ELISA, Pg/ml.;Th1 cell percentage. Timepoint: Before intervention, Three months after intervention, six months after intervention. Method of measurement: flow cytometry, percentage.;Treg cell percentage. Timepoint: Before intervention, Three months after intervention, six months after intervention. Method of measurement: flow cytometry, percentage.;Th17 cell percentage. Timepoint: Before intervention, Three months after intervention, six months after intervention. Method of measurement: flow cytometry, percentage.;Interleukin 17 level. Timepoint: Before intervention, Three months after intervention, six months after intervention. Method of measurement: ELISA. Pg/ml.;Interleukin 17 gene expression. Timepoint: Before intervention, Three months after intervention, six months after intervention. Method of measurement: QRT-PCR.;Interleukin 23 gene expression. Timepoint: Before intervention, Three months after intervention, six months after intervention. Method of measurement: QRT-PCR.;Interleukin 10 gene expression. Timepoint: Before intervention, Three months after intervention, six months after intervention. Method of measurement: QRT-PCR.;Interleukin 4 gene expression. Timepoint: Before intervention, Three months after intervention, six mo | — |
Secondary
| Measure | Time frame |
|---|---|
| CBC. Timepoint: Before intervention. Method of measurement: cells/L ? g/L ? fL (femtoliters)? pg (picograms).;Liver enzymes. Timepoint: Before intervention. Method of measurement: U/L.;Stool Exam. Timepoint: Before intervention. Method of measurement: Without unit.;Crohn's Disease Activity Index (CDAI). Timepoint: Before intervention, Six months after intervention. Method of measurement: Standard form, SCORE.;CRP. Timepoint: Before treatment. Method of measurement: mg/L.;ESR. Timepoint: Before intervention. Method of measurement: mm/hr. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHaniyeh Ghaffari Nazari
Mashhad University of Medical Sciences
Outcome results
None listed