Low Dose IL-2 for the Treatment of Crohn's Disease
Boston Children's Hospital
Summary
The purpose of this study is to determine the safety and maximum effective dose (MED) of Interleukin-2 in subjects with moderate-to-severe crohn's disease.
Description
Despite recent advances in treatment, a significant proportion of patients with Crohn's disease have suboptimal responses to medical therapy, leaving an urgent need to identify new therapies. One promising new approach to treat IBD is through the manipulation of regulatory T cells (Tregs). Tregs are an immune modulating subset of CD4+ lymphocytes that antagonize the activation and effector function of multiple immune cell types and promote tolerance to self-antigens. Adoptively transferred Tregs are effective in murine models of IBD. An alternative approach to disease management through Treg m…
Eligibility
- Age range
- 12–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 12-80 years. Maximum age limit for subjects recruited at BCH will be 30 years. 2. A diagnosis of CD made by standard clinical, radiological, endoscopic and histological criteria. a. A subset of patients with Ileostomies or colostomies will be permitted. 3. Adult subjects with moderate-to-severe CD (CDAI score 220-450) a. a modified CDAI will be used to assess patients with ileostomies/colostomies. Number of liquid stools per day will be substituted for number of bag empties per day. 4. Evidence of endoscopic inflammation accessible via ileocolonoscopy or ile…
Interventions
- DrugInterleukin-2 (aldesleukin).
Description of intervention is covered in "Arm", above.
Locations (3)
- Boston Children's HospitalBoston, Massachusetts
- Brigham and Women's HospitalBoston, Massachusetts
- Mount SinaiNew York, New York