Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease - Full Text View

Sponsor:	Osiris Therapeutics
Information provided by (Responsible Party):	Osiris Therapeutics
ClinicalTrials.gov Identifier:	NCT01233960

Purpose

To provide open-label re-treatment with PROCHYMAL to subjects enrolled in companion Protocol 603 to evaluate the safety in subjects with active Crohn's disease who are resistant to standard Crohn's disease therapies.

Condition	Intervention	Phase
Crohn's Disease	Drug: adult human mesenchymal stem cells	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multicenter, Open-label Study to Evaluate the Safety of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects Who Have Received Previous Remestemcel-L Induction Treatment for 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 [ Time Frame: 180 Days after first infusion in Protocol 603 ] [ Designated as safety issue: No ]
CDAI at or below 150 and increase in IBDQ

Secondary Outcome Measures:

Disease Improvement [ Time Frame: 180 Days after first infusion in Protocol 603 ] [ Designated as safety issue: No ]
CDAI response to treatments is defined as a CDAI of 150 or below, or a reduction in CDAI of at least 100 points.
Improvement in Quality of Life (IBDQ) [ Time Frame: 180 Days after first infusion in Protocol 603 ] [ Designated as safety issue: No ]
IBDQ response to treatment is defined as IBDQ of 170 or above, or an increase in IBDQ of at least 16 points.
Number of Adverse events as a measure of safety [ Time Frame: 180 Days after first infusion in Protocol 603 ] [ Designated as safety issue: Yes ]
Infusional toxicity as a measure of safety and tolerability [ Time Frame: 180 Days after first infusion in Protocol 603 ] [ Designated as safety issue: Yes ]
Infusional toxicity will be evaluated by continuously monitoring the subject's vital signs and O2 saturation by pulse oximetry from the time of PROCHYMAL administration until two hours after infusion is complete.

Estimated Enrollment:	120
Study Start Date:	September 2010
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Prochymal Infusions of Prochyaml on days 42-45, 84-87, and 126-129 after first infusion in Protocol 603. Each infusion of PROCHYMAL (remestemcel-L) will contain 200 million cells.	Drug: adult human mesenchymal stem cells PROCHYMAL will be administered IV in a total volume of 300 ml (200 million cells) at a rate of 4-6 ml/minute. Treatments will be administered on Days 42-45, Days 84-87, and Days 126-129 following first infusion in Protocol 603. Other Names: Prochymal adult human mesenchymal stem cells remestemcel-L

Detailed Description:

Subjects will receive infusions of PROCHYMAL on Day 42, Day 84, and Day 126 after initial infusion of PROCHYMAL in Protocol 603. Each infusion will contain 200 million cells. As subjects will be required to be in Protocol 603 during the entire duration of their participation in Protocol 611, all concomitant medication and safety information will be monitored by Protocol 603 and the combination of data from the two protocols

Eligibility

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

Criteria

Inclusion Criteria:

Subject must have qualified for, enrolled in, and provided written ICF and authorization for use and disclosure of PHI for Protocol 603 after the August 3, 2010.
Subject successfully completed all screening assessments in Protocol 603 as required by Protocol 603.
Subject successfully completed the full course of each of the four infusions of investigational agent on Days 0, 3, 7, and 14 of Protocol 603 after August 3, 2010.
Subject must enroll in Protocol 611 on or before the 45th day after first infusion in Protocol 603.
Subject must provide written ICF and authorization for use and disclosure of PHI for Protocol 611.

Exclusion Criteria:

Subject is unwilling or unable to adhere to requirements of Protocol 611.
Subject had confirmed respiratory distress during a PROCHYMAL infusion in any prior PROCHYMAL study.
Subject had a serious adverse event in any previous PROCHYMAL study that was deemed by the principal investigator of that study to be possibly or probably related to PROCHYMAL and also that was within 48 h after a PROCHYMAL infusion.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233960

Contacts

Contact: Linda Custer

443-545-1807

Locations

United States, California
University of California, San Francisco	Recruiting
San Francisco, California, United States, 94115
United States, Florida
Clinical Research of West Florida	Recruiting
Clearwater, Florida, United States, 33765
Shafran Gastroenterology Center	Recruiting
Winter Park, Florida, United States, 32789
United States, Illinois
University of Chicago	Recruiting
Chicago, Illinois, United States, 60611
United States, Kansas
Cotton-O'Neil Clinical Research Center	Recruiting
Topeka, Kansas, United States, 66606
United States, Maryland
University of Maryland, Baltimore	Recruiting
Baltimore, Maryland, United States, 21201
Chevy Chase Clinical Research	Recruiting
Chevy Chase, Maryland, United States, 20815
United States, Missouri
Saint Louis Center for Clinical Research	Recruiting
St. Louis, Missouri, United States, 63128
St. Louis Center for Clinical Studies	Recruiting
St. Louis, Missouri, United States, 63128
United States, New Hampshire
Dartmouth HItchcock Medical Center	Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New York
Mount Sinai School of Medicine	Recruiting
New York, New York, United States, 10029
Weill Cornell Medical College	Recruiting
New York, New York, United States, 10028
United States, Tennessee
Gastroenterology Center of the Midsouth, PC	Recruiting
Germantown, Tennessee, United States, 38138
Vanderbilt University Medical Center	Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor University Medical Center	Recruiting
Dallas, Texas, United States, 75246
United States, Virginia
McGuire Research Institute	Recruiting
Richmond, Virginia, United States, 23249
Australia, South Australia
Royal Adelaide Hospital	Recruiting
Adelaide, South Australia, Australia
Australia, Victoria
Royal Melbourne Hospital	Recruiting
Melbourne, Victoria, Australia
New Zealand
University of Otago	Recruiting
Christchurch, New Zealand
Waikato Hospital	Recruiting
Hamilton, New Zealand

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:	NCT01233960 History of Changes
Other Study ID Numbers:	611
Study First Received:	November 2, 2010
Last Updated:	May 15, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Osiris Therapeutics:

Crohn's Disease
Adult Stem Cell Therapy
inflammation of the gastrointestinal tract

Additional relevant MeSH terms:

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis

Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 23, 2012