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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
History of Changes

May 26, 2010
July 14, 2014
August 2010
February 2012   (final data collection date for primary outcome measure)
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.
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 ]
Complete list of historical versions of study NCT01155362 on ClinicalTrials.gov Archive Site
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.
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 ]
Not Provided
Not Provided
 
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
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Crohn's Disease
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: 1 unit Human Placenta-Derived Cells PDA001
    Intervention: Biological: Human Placenta-Derived Cells PDA001 Intravenous Infusion
  • Experimental: 4 units Human Placenta-Derived Cells PDA001
    Intervention: Biological: Human Placenta-Derived Cells PDA001 Intravenous Infusion
  • Experimental: vehicle control
    Intervention: Biological: Human Placenta-Derived Cells PDA001 Intravenous Infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
April 2014
February 2012   (final data collection date for primary outcome measure)

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).
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01155362
CCT-PDA001-002
Yes
Celgene Corporation
Celgene Corporation
Celgene Cellular Therapeutics
Study Director: Steven Fishkoff, MD Celgene Cellular Therapeutics, a division of Celgene Corporation
Celgene Corporation
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP