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Completed

NCT Number: NCT01090817

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

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

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Key information

Conditions

Crohn Disease Colitis Colonic Diseases Digestive System Diseases Enteritis Gastroenteritis Gastrointestinal Diseases Ileal Diseases Ileitis Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Gastroenterology and Hepatology, Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mesenchymal stromal cells (MSC) for infusion

Drug

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

Other names: No other names

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

    Time frame: Six weeks

    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.

Secondary outcomes

  1. Incidence of infusional toxicity

    Time frame: Six weeks

    Subjects will receive mesenchymal stromal cell therapy, 2X10E6/kg weekly by IV infusion for 4 weeks and will be assessed for 4 hours post infusion

  2. Induction of remission

    Time frame: Six weeks

    Crohn's disease activity index assessed as below 150

  3. Improved quality of life

    Time frame: Six weeks

    Increase in IBDQ and SF-36 scores measured at six weeks

  4. Endoscopic improvement.

    Time frame: Six weeks

    Crohn's disease endoscopic improvement score will be measured at repeat endoscopy six weeks after start of treatment

Sponsors and collaborators

Lead sponsor

R.P.Herrmann

Other

Collaborators

  • Concord Hospital
  • Sir Charles Gairdner Hospital
  • The Alfred
  • The Queen Elizabeth Hospital

Registry information

Official study title

A Multicentre Australian Phase 2 Study to Evaluate Safety and Efficacy of Mesenchymal Stromal Cells for Treating Biologic Refractory Crohn's Disease

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Mar 23, 2010
Registry last updated
Jun 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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