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Placental Cell Infusion Therapy for Crohn's Disease

Objective

The purpose of this study is to investigate the safety and efficacy (effectiveness) of a potential new therapy (PDA001), and its ability to relieve the symptoms of Crohn’s disease. This study involves up to five IV infusions of PDA001 administered at University of Colorado Hospital.

Study subjects:

Patients with active moderate-to-severe Crohn's disease that involves the colon to some extent and is not responding well to current treatment.

Study treatment:

Celgene PDA001 placental cell infusions

IRB Protocol Number
13-1566

All Other Trials

  • Digestive
  • Immune Disorders
Contact
Katelyn Cowan at 303-724-7875
or Katelyn.Cowan@ucdenver.edu
Eligibility and Other Participant Information

Inclusion criteria

  • Must have inflammatory Crohn's Disease with colonic involvement diagnosed at least 6 months but no greater than 10 years ago
  • Must have confirmation of ongoing Crohn’s disease with colonic involvement activity by colonoscopy at the beginning of the study. Note: Patients can still be enrolled if their Crohn’s disease involves other areas of the gastrointestinal tract (GI) in addition to the colon
  • Must have failed at least one other standard therapy for Crohn’s disease

This research study includes:

  • Physical examination and blood draws
  • Receiving up to five IV infusions of placental cells
  • Recording of Crohn's disease symptoms in a take-home diary

 

Location

  • University of Colorado Hospital (UCH)
    12605 E. 16th Ave.
    Aurora, CO 80045