drugset / Trial / NCT04224558
Stem Cell Transplantation in Crohn's Disease
NaSingle-groupOpen-labelTreatment
Summary
Unfortunately, some patients with Crohn's disease (CD) fail to respond to the best clinical treatments and some only experience temporary benefit. For severe Crohn's disease, there is an experimental treatment called "high dose immunoablation" followed by autologous hematopoietic stem cell transplantation (HSCT). This study removes over active lymphocytes (immunoablation) and replaces them using blood stem cells that have been taken from the patient's own body. The aim of the study is to reset or reprogram the patient's immune system to its state prior to diagnosis.
Timeline
- Start
- 2019-11-15
- Primary completion
- 2027-09-30
- Completion
- 2027-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Peripheral Blood Stem Cell Infusion | Cell therapy | — | — |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | — | — |
| Background | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 25 mg/kg | — |
| Background | Acetaminophen | Small molecule | — | — |
| Background | Cyclophosphamide | Other / unclassified | 25 mg/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 50 mg/kg | Intravenous |
| Background | Diphenhydramine | Unknown | — | — |
| Background | Fludarabine | Small molecule | 30 mg/m2 | — |
| Background | Methylprednisolone | Other / unclassified | — | — |
| Background | Thymoglobulin | Protein / enzyme biologic | 2.5 mg/kg | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |
| Background | filgrastim | Protein / enzyme biologic | 10 ug/kg | Subcutaneous |