Safety and Tolerability Of Allogeneic Mesenchymal Stromal Cells in Pediatric Inflammatory Bowel Disease

PHASE1CompletedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

June 7, 2018

Primary Completion Date

September 5, 2018

Study Completion Date

September 5, 2018

Conditions
Inflammatory Bowel Diseases
Interventions
BIOLOGICAL

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.

Trial Locations (1)

20010

Children's National Medical Center, Washington D.C.

All Listed Sponsors
lead

Catherine Bollard

OTHER

NCT02150551 - Safety and Tolerability Of Allogeneic Mesenchymal Stromal Cells in Pediatric Inflammatory Bowel Disease | Biotech Hunter | Biotech Hunter