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A Multi-Center Study to Evaluate the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Moderate-to-Severe Crohn's Disease

This study has been completed.
Sponsor:
Collaborator:
Celgene Cellular Therapeutics
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01155362
First received: May 26, 2010
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

The primary objective of the study is to estimate the treatment effect of 3 different doses of PDA001 versus placebo in subjects with moderate-to-severe Crohn's Disease. The secondary objective of the study is to assess the safety and tolerability of PDA001 versus placebo in the above-mentioned patient population.


Condition Intervention Phase
Crohn's Disease
Biological: Human Placenta-Derived Cells PDA001 Intravenous Infusion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a, Randomized, Double Blind, Placebo Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Moderate-to-Severe Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • A reduction from baseline by 25% and/or > 100 points in the Crohn's Disease Activity Index (CDAI) scores at both Week 4 (Day 29) and at Week 6 (Day 43). [ Time Frame: Week 4 (Day 29) and Week 6 (Day 43) ] [ Designated as safety issue: No ]
    Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.


Secondary Outcome Measures:
  • The induction of a clinical remission defined as a Crohn's Disease Activity Index score of < 150 points at both Week 4 (Day 29) and Week 6 (Day 43) [ Time Frame: Week 4 (Day 29) and Week 6 (Day 43) ] [ Designated as safety issue: No ]
    Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.


Enrollment: 50
Study Start Date: August 2010
Study Completion Date: April 2014
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 unit Human Placenta-Derived Cells PDA001 Biological: Human Placenta-Derived Cells PDA001 Intravenous Infusion
1 of 3 treatment doses (1 unit, 4 units, or vehicle control) intravenous infusion on days 0 and 7
Experimental: 4 units Human Placenta-Derived Cells PDA001 Biological: Human Placenta-Derived Cells PDA001 Intravenous Infusion
1 of 3 treatment doses (1 unit, 4 units, or vehicle control) intravenous infusion on days 0 and 7
Experimental: vehicle control Biological: Human Placenta-Derived Cells PDA001 Intravenous Infusion
1 of 3 treatment doses (1 unit, 4 units, or vehicle control) intravenous infusion on days 0 and 7

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females ages 18-75 years
  2. Understand and voluntarily sign an informed consent
  3. Able to adhere to the study visit schedule and other protocol requirements
  4. Minimum weight of 50 kg
  5. A female of childbearing potential (FCBP)† must have a negative urine pregnancy test at screening (Visit 1) and immediately prior to all doses of IP. In addition, sexually active FCBP must agree to use two of the adequate forms of contraception methods for the duration of the study and the follow-up period. A FCBP must agree to have pregnancy tests at least every 4 weeks during the study. Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP for the duration of the study and the follow-up period.
  6. Subject must have inflammatory CD 6 months prior to treatment and have confirmation of ongoing disease activity by colonoscopy or (other method) at screening
  7. Subject must have a CDAI score > 220 and < 450 as assessed between Visit 1 and Visit 2
  8. The Subject must have failed, i.e., had an inadequate response or lost response (recurrence of symptoms) to an agent, or documented intolerance to an agent at any time

Exclusion Criteria:

  1. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
  2. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study

A female of childbearing potential is a sexually mature woman who:

  1. has not undergone a hysterectomy or bilateral oophorectomy
  2. has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155362

Locations
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
University of California, Irvine
Orange, California, United States, 92868
United States, Connecticut
Yale School of Medicine Digestive Diseases
New Haven, Connecticut, United States, 06510
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202-5149
United States, New York
Mt Sinai Hospital
New York, New York, United States, 10029
Rochester General Hospital
Rochester, New York, United States, 14621
Stony Brook University
Stony Brook, New York, United States, 11794-8173
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106-5066
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37212
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Virginia
McGuire VA Medical Center
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
Celgene Corporation
Celgene Cellular Therapeutics
Investigators
Study Director: Steven Fishkoff, MD Celgene Cellular Therapeutics, a division of Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01155362     History of Changes
Other Study ID Numbers: CCT-PDA001-002
Study First Received: May 26, 2010
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
Human Placenta-Derived Cells for the Treatment of Moderate-to-Severe Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 18, 2014