Evaluation of PROCHYMAL[tm] Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease - Full Text View

Sponsor:	Osiris Therapeutics
Information provided by (Responsible Party):	Osiris Therapeutics
ClinicalTrials.gov Identifier:	NCT00482092

Purpose

Osiris 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 at least one biologic agent. The protocol investigates the safety and efficacy of using PROCHYMAL[tm] 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.

Condition	Intervention	Phase
Crohn's Disease	Drug: adult human mesenchymal stem cells Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of PROCHYMAL[tm] (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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

U.S. FDA Resources

Further study details as provided by Osiris Therapeutics:

Primary Outcome Measures:

Disease remission (CDAI at or below 150) [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Disease improvement (Reduction by at least 100 points in CDAI) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Improvement in quality of life (IBDQ) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Reduction in number of draining fistulas [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	270
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Placebo	Drug: Placebo Placebo
Active Comparator: 2 Low dose (600 million cells total over four infusions in two weeks)	Drug: 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: 3 High dose (1200 million cells delivered in four infusions over two weeks)	Drug: 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.

Detailed 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[tm] 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.

Osiris 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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

failed (within last 2 yr) or intolerant of at least one steroid AND exactly one immunosuppressant AND at least 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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482092

Contacts

Contact: Linda Custer, PhD

443 545 1807

lcuster@osiris.com

Show 61 Study Locations

Sponsors and Collaborators

Osiris Therapeutics

Investigators

Study Director:

Linda Custer, PhD

Osiris Therapeutics

More Information

No publications provided

Responsible Party:	Osiris Therapeutics
ClinicalTrials.gov Identifier:	NCT00482092 History of Changes
Obsolete Identifiers:	NCT00609232
Other Study ID Numbers:	Osiris 603
Study First Received:	May 30, 2007
Last Updated:	January 10, 2012
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Osiris Therapeutics:

Crohn's disease
adult stem cell therapy

Additional relevant MeSH terms:

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis

Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on February 07, 2012