Prochymal[TM] to Treat Crohn's Disease - Full Text View

Purpose

This study will test the safety and effectiveness of Prochymal[TM] for treating patients with moderate to severe Crohn's disease. Prochymal[TM] contains human mesenchymal stem cells obtained from healthy adult volunteers and grown in the laboratory in large numbers. Prochymal[TM] has been shown to decrease inflammation associated with Crohn's disease.

Patients 18 to 70 years of age with Crohn's disease that is not well controlled with standard treatment may be eligible for this study.

Participants are randomly assigned to one of three study groups to receive either a high dose of Prochymal[TM], a low dose of Prochymal[TM] or placebo. The study medications are given as four separate intravenous (through a vein) infusions over 2 weeks (study days 0 to 14). Each infusion takes between 60 and 75 minutes. During the first four weeks of the study patients have four physical examinations and two fistula assessments. They complete several inflammatory bowel disease questionnaires (IBDQ) and fill out symptoms diaries to calculate their Crohn's disease activity index (CDAI). Patients are followed for 2 years with six clinic visits on study days 28, 42, 56, 84, months 12 and 24 for the following procedures:

Medical history, physical examination, blood tests, review of medicines taken - all visits
Urine and stool tests, fistula assessment, IBDQ and CDAI - days 28, 42, 56, 84
CT scans of chest, abdomen and pelvis - months 12 and 24

Patients whose symptoms improved during the treatment phase (days 0-28) but subsequently worsened may receive up to two more treatment cycles with Prochymal[TM] (four infusions each cycle).

Patients may also participate in a sub-study to learn how immune cells and proteins they release called cytokines react to Prochymal[TM] infusions. For this sub-study, patients have the following procedures:

Blood tests
Colonoscopy and biopsy. For this test, the patient is given a sedative. A long, flexible, lighted tube is inserted into the rectum and slowly guided into the colon to examine for inflammation. In addition, a small tissue sample is collected during the procedure for laboratory testing....

Condition	Intervention	Phase
Colitis Crohn's Disease Inflammatory Bowel Disease	Drug: PROCHYMAL Drug: Mesenchymal Stem Cells (MSC) Procedure: Colonoscopy Procedure: Infusion	Phase III

Genetics Home Reference related topics:

Crohn disease

MedlinePlus related topics:

Crohn's Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

Official Title:	A Phase III, Multicenter Placebo-Controlled, Randomized, Double-Blind Study to Evaluate Safety/Efficacy of PROCHYMALTM IV Infusion for Induction of Remission in Subjects Experiencing Tx of Refractory Moderate to Severe Crohn's Disease

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:

Increase of at least 75 percent in the proportion of subjects achieving remission at day 28 who received a PROCHYMAL dose level as compared with the proportion of subjects achieving remission at Day 28 who received placebo. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Significant increase in proportion of subjects achieving at least 100-pt. reduction in CDAI/score day 28 who received PROCHYMAL dose level compared with proportion of subjects achieving at least 100-pt. reduction in CDAI/day 28 who rec'd placebo. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	January 2008

Intervention Details:

N/A

Detailed Description:

The objective of this NIH-specific substudy is for immunological monitoring of human Mesenchymal Stem Cells (PROCHYMAL) in subjects experiencing treatment-refractory moderate-to-severe Crohn's disease. Based on the pre-clinical and clinical studies conducted to date in which human Mesenchymal Stem Cells (hMSC) have resolved or significantly reduced the severity of Crohn's Disease and GI-inflammatory graft-versus-host disease, it is theorized that administration of hMSCs will reduce the severity of Crohn's Disease and induce remission.

Eligibility

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

Criteria

INCLUSION CRITERIA:

NIH subjects participating in the main protocol will be asked to volunteer for the NIH Sub-Study.

EXCLUSION CRITERIA:

Platelet count less than 90,000

PT INR greater than 1.3 or PTT greater than 3 sec control

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609232

Contacts


Contact: Patient Recruitment and Public Liaison Office	(800) 411-1222	prpl@mail.cc.nih.gov

Contact: TTY	1-866-411-1010

Locations


United States, Maryland
	National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
	Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

More Information

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

Mary JY, Modigliani R. Development and validation of an endoscopic index of the severity for Crohn's disease: a prospective multicentre study. Groupe d'Etudes Therapeutiques des Affections Inflammatoires du Tube Digestif (GETAID). Gut. 1989 Jul;30(7):983-9.

D'Haens GR, Geboes K, Peeters M, Baert F, Penninckx F, Rutgeerts P. Early lesions of recurrent Crohn's disease caused by infusion of intestinal contents in excluded ileum. Gastroenterology. 1998 Feb;114(2):262-7.

Hart R, Classen M. Complications of diagnostic gastrointestinal endoscopy. Endoscopy. 1990 Sep;22(5):229-33. Review.

Responsible Party:	( Linda Custer, Ph.D. )
Study ID Numbers:	080063, 08-I-0063
First Received:	February 4, 2008
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00609232
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Stem Cell

Crohn's Disease

Infusion

Placebo

Prochymal

Crohn Disease

Inflammatory Bowel Disease

Colitis

Study placed in the following topic categories:

Digestive System Diseases

Gastrointestinal Diseases

Colonic Diseases

Crohn Disease

Inflammatory Bowel Diseases

Gastroenteritis

Intestinal Diseases

Colitis

ClinicalTrials.gov processed this record on November 03, 2008

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00609232