An Australian Study of Mesenchymal Stromal Cells for Crohn's Disease

R

R.P.Herrmann

Status and phase

Completed
Phase 2

Conditions

Crohn Disease

Treatments

Drug: Mesenchymal stromal cells (MSC) for infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT01090817
CTN2010/0098 (Other Identifier)
EC2009/123

Details and patient eligibility

About

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

Enrollment

21 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

21 participants in 1 patient group

Mesenchymal stromal cells
Experimental group
Description:
Mesenchymal stromal cells administered weekly for 4 weeks
Treatment:
Drug: Mesenchymal stromal cells (MSC) for infusion

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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