NCT01090817

Brief Summary

Despite the advent of newer biologic therapies such as infliximab for Crohn's disease, a form of autoimmune inflammatory bowel disease, a proportion of patients are refractory to such therapy and require surgery. The hypothesis is that mesenchymal stromal cell therapy using third party human cultured cells will be safe and effective

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2010

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 9, 2015

Status Verified

June 1, 2015

Enrollment Period

4.4 years

First QC Date

March 22, 2010

Last Update Submit

June 7, 2015

Conditions

Crohn Disease

Keywords

mesenchymal stromal cellsileitiscolitis

Outcome Measures

Primary Outcomes (1)

  • Clinical response to MSC: Reduction of Crohn's disease Activity score by 100 points or more at six weeks post start of therapy

    Colonoscopy and biopsy as well as clinical parameters used for the Crohn's disease acivity (www.ibdaustralia.org/cdai/) will be undertaken at screening pre-therapy and at 6 weeks after start of therapy.

    Six weeks

Secondary Outcomes (4)

  • Incidence of infusional toxicity

    Six weeks

  • Induction of remission

    Six weeks

  • Improved quality of life

    Six weeks

  • Endoscopic improvement.

    Six weeks

Study Arms (1)

Mesenchymal stromal cells

EXPERIMENTAL

Mesenchymal stromal cells administered weekly for 4 weeks

Drug: Mesenchymal stromal cells (MSC) for infusion

Interventions

Mesenchymal stromal cells (MSC) for infusionDRUG

MSC 2X10E6/kg recipient weight are infused over 15 minutes intravenously weekly for 4 weeks

Also known as: No other names
Mesenchymal stromal cells

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Colonic or small bowel Crohn's disease based on endoscopic appearances and histology
  • Refractory to induction with infliximab or adalimumab; or have lost response to these agents; or have had side effects precluding their further use
  • Where there has been loss of response to one of these agents, the other must be tried before being eligible
  • Crohn's disease activity score (CDAI) 250 or more.
  • C-reactive protein \>10mg/L
  • Surgery must have been offered to the subject (if appropriate) and declined
  • Signed informed consent

You may not qualify if:

  • Active sepsis, perforating disease. Coexistent perianal fistulous disease is permitted, providing no co-existent infection within previous 4 weeks
  • Chronic stricturing disease in isolation
  • Coexistent CMV disease
  • Prior history of malignancy
  • Pregnant or unwilling to practice contraceptive therapy or breast feeding females
  • Last biologic therapy must be greater than 4 weeks prior, must be on stable corticosteroid dose for 14 days prior, during therapy and for 14 days after therapy, must be on stable immunomodulator dose (eg, azathioprine) for 14 days prior, during therapy and for 14 days after.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology and Hepatology, Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Related Publications (1)

  • Forbes GM, Sturm MJ, Leong RW, Sparrow MP, Segarajasingam D, Cummins AG, Phillips M, Herrmann RP. A phase 2 study of allogeneic mesenchymal stromal cells for luminal Crohn's disease refractory to biologic therapy. Clin Gastroenterol Hepatol. 2014 Jan;12(1):64-71. doi: 10.1016/j.cgh.2013.06.021. Epub 2013 Jul 19.

    PMID: 23872668DERIVED

MeSH Terms

Conditions

Crohn DiseaseIleitisColitis

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesEnteritisIleal DiseasesColonic Diseases

Study Officials

  • Geoff Forbes, MD

    Royal Perth Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director Cell and Tissue Therapies Western Australia

Study Record Dates

First Submitted

March 22, 2010

First Posted

March 23, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2014

Study Completion

June 1, 2015

Last Updated

June 9, 2015

Record last verified: 2015-06

Locations

AU(1)