Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01051622 | PBMC (Peripheral Blood Mononuclear Cells) /Lymphocyte SPECT (Single Photon Emission Computerized Tomography) Imaging in Crohn's Disease | PHASE1 | COMPLETED | 13 | — | — | Jan 1, 2010 | Feb 1, 2011 | Jun 2, 2014 | 2 | Belgium, Netherlands |
| Arm | Type | Description |
|---|---|---|
| PBMC Trafficking | EXPERIMENTAL | In part B, Patients undergo a blood draw (up to150 mL) and the PBMC's are separated and selected or 99mTc-HMPAO labeling. The purified and labelled cells will be re-introduced into the patient by intravenous infusion and one SPECT scan and up to 8 serial planar scintigraphy scans will initially be conducted over up to 6 hours within 1 scan session. All suitable patients showing evidence of cellular uptake in the ileo-caecal region and/or small bowel at Visit 1 will be progressed to an identical second cell labeling and scanning session at Visit 2 (48 hours later). Subjects showing no evidence of cellular uptake in the ileo-caecal region or small bowel at Visit 1 (negative scan) will be withdrawn from the study and proceed to the follow-up. |
| T Lymphocyte Trafficking | EXPERIMENTAL | In part B, Patients undergo a blood draw (up to150 mL) and the T lymphocyte cells are separated and selected or 99mTc-HMPAO labeling. The purified and labelled cells will be re-introduced into the patient by intravenous infusion and one SPECT scan and up to 8 serial planar scintigraphy scans will initially be conducted over up to 6 hours within 1 scan session. All suitable patients showing evidence of cellular uptake in the ileo-caecal region and/or small bowel at Visit 1 will be progressed to an identical second cell labeling and scanning session at Visit 2 (48 hours later). Subjects showing no evidence of cellular uptake in the ileo-caecal region or small bowel at Visit 1 (negative scan) will be withdrawn from the study and proceed to the follow-up. visit. |
| Name | Type | Description |
|---|---|---|
| Labeling Ceretec | OTHER | Technetium-99m is used to radiolabel cells of interest i.e PBMC's |
Inclusion A subject will be eligible for inclusion in this study only if all of the following criteria apply: Part A only: 1. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, vital signs, ECG, complete...