Overview

This trial is active, not recruiting.

Condition crohn's disease
Treatments adult human mesenchymal stem cells, placebo
Phase phase 3
Sponsor Mesoblast International Sàrl
Start date May 2007
End date December 2016
Trial size 330 participants
Trial identifier NCT00482092, CRD 603, NCT00609232

Summary

Protocol 603 is enrolling subjects with moderate-to-severe Crohn's disease who are intolerant to, or have previously failed therapy with, at least one steroid and at least one immunosuppressant and a biologic monoclonal anti-body to tumor necrosis factor alpha. The protocol investigates the safety and efficacy of using PROCHYMAL® adult human stem cells to induce remission. PROCHYMAL is delivered through a vein in the arm four times over two weeks, for approximately an hour each time.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Placebo
placebo
Placebo
(Active Comparator)
Low dose (600 million cells total over four infusions in two weeks)
adult human mesenchymal stem cells
Intravenous infusion of suspension of adult human mesenchymal stem cells, total of 1200 million (high dose) or 600 million (low dose) cells infused in four visits over two weeks.
(Active Comparator)
High dose (1200 million cells delivered in four infusions over two weeks)
adult human mesenchymal stem cells
Intravenous infusion of suspension of adult human mesenchymal stem cells, total of 1200 million (high dose) or 600 million (low dose) cells infused in four visits over two weeks.

Primary Outcomes

Measure
Disease remission (CDAI at or below 150)
time frame: 28 days

Secondary Outcomes

Measure
Disease improvement (Reduction by at least 100 points in CDAI)
time frame: 28 days
Improvement in quality of life (IBDQ)
time frame: 28 days
Reduction in number of draining fistulas
time frame: 28 days

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - failed (within last 2 yr) or intolerant of at least one steroid AND at least one immunosuppressant AND at EXACTLY one biologic - CDAI between 250 and 450, inclusive - endoscopically or radiographically confirmed Crohn's disease of ileus or colon or both - CRP of at least 5 mg/l (0.5 mg/dl)*OR* CDAI of at least 300 - weight between 40 and 150 kg, inclusive - adequate renal function - negative PPD test (or evaluated low risk of TB activation) Exclusion Criteria: - HIV or hepatitis infection active - allergy to CT contrast agents, or to bovine or porcine products - symptomatic fibrostenotic Crohn's disease - permanent ostomy - biologic therapy within past 90 d - prednisone greater than 20 mg/d within past month - short-bowel syndrome - total parenteral nutrition - abnormal liver function - malignancy active within past 5 years (except completely resected basal or squamous cell carcinoma of skin) - enteric pathogens, including C. difficile - history of colonic mucosal dysplasia - current or prior evidence of TB (unless risk of activation or re-activation deemed low)

Additional Information

Official title A Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Induction of Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's Disease
Description A significant number of individuals with Crohn's disease do not find relief with existing steroidal, immunosuppressive, or biologic therapies, and are forced to seek surgery or other drastic measures for treatment. PROCHYMAL® adult human stem cells are manufactured from healthy, volunteer donors, extensively tested, and are stored to be available as needed. Human and animal studies have shown that the cells do not require any donor-recipient matching. The cells may have both immunosuppressive and healing benefits in Crohn's disease. The cells naturally migrate specifically to sites of inflammation, so their effects are believed to be local and self-limiting rather than systemic. Protocol 603 is enrolling subjects to evaluate the ability of PROCHYMAL to induce remission in subjects with moderate-to-severe disease (Crohn's disease activity index -- CDAI -- of between 250 and 450, inclusive) who have failed or been intolerant of at least one drug in each of the steroid, immunosuppressant, and biologic classes.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Mesoblast, Ltd..