NIH Clinical Research Studies

Protocol Number: 08-I-0063

Active Accrual, Protocols Recruiting New Patients

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
Number:
08-I-0063
Summary:
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.

Sponsoring Institute:
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
INCLUSION CRITERIA:

NIH subjects participating in the main protocol will be asked if they would like to take part in additional research procedures (this protocol) related to the main protocol.

EXCLUSION CRITERIA:

-Platelet count less than 90,000

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

Special Instructions:
Currently Not Provided
Keywords:
Stem Cell
Crohn's Disease
Infusion
Placebo
Prochymal
Recruitment Keyword(s):
Crohn Disease
Inflammatory Bowel Disease
Colitis
Condition(s):
Colitis
Crohn's Disease
Inflammatory Bowel Disease
Investigational Drug(s):
PROCHYMAL
Investigational Device(s):
None
Intervention(s):
Drug: PROCHYMAL
Drug: Mesenchymal Stem Cells (MSC)
Procedure/Surgery: Colonoscopy
Procedure/Surgery: Infusion
Drug: PROCHYMAL
Supporting Site:
National Institute of Allergy and Infectious Diseases

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):
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 ThŽrapeutiques 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.

Active Accrual, Protocols Recruiting New Patients

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