1
Participants
Start Date
June 7, 2018
Primary Completion Date
September 5, 2018
Study Completion Date
September 5, 2018
Allogeneic bone marrow-derived mesenchymal stromal cells
This study is a pilot phase 1 study of patients with moderately to severely active Crohn Disease (CD) and ulcerative colitis (UC) (≥ 18 years, Mayo score: ≥6 or CDAI: ˃ 220; \<18 years, Pediatric Crohn's Disease Activity Index (PCDAI) :\> 30) or Pediatric Ulcerative Colitis Activity Index (PUCAI) : \>34). A fixed dose will be studied: 1 x 106 cells/kg administered intravenously (IV) weekly for 4 consecutive weeks, with the option of an additional 4 weeks of treatment, at the discretion of the principal investigator.
Children's National Medical Center, Washington D.C.
Catherine Bollard
OTHER