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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

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ClinicalTrials.gov Identifier: NCT01155362
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : July 22, 2020
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Celularity Incorporated

Study Description
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Brief Summary:
The primary objective of the study is to estimate the treatment effect of PDA001 (evaluating 3 different PDA001 dosings) 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 or disease Intervention/treatment Phase
Crohn's Disease Biological: Human Placenta-Derived Cells PDA001 Intravenous Infusion Drug: Vehice Control Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 unit Human Placenta-Derived Cells PDA001
1 unit PDA001 in 240 millilters (mL) infused intravenously in one arm on Day 0 and Day 7.
 Biological: Human Placenta-Derived Cells PDA001 Intravenous Infusion
Experimental: 4 units Human Placenta-Derived Cells PDA001
4 units PDA001 in 240 mL infused intravenously in one arm on Day 0 and Day 7.
 Biological: Human Placenta-Derived Cells PDA001 Intravenous Infusion
Placebo Comparator: vehicle control
4 units placebo in 240 mL infused intravenously in one arm on Day 0 and Day 7.
 Drug: Vehice Control
Other Name: Placebo
Experimental: 8 units Human Placenta-Derived Cells PDA001
4 units PDA-001 in 240 mL infused intravenously in each arm on Day 0 and Day 7 or 8 units PDA-001 in 240 mL infused intravenously in one arm on Day 0 and Day 7
 Biological: Human Placenta-Derived Cells PDA001 Intravenous Infusion


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
    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 :
  1. 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) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155362


Locations
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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
Celularity Incorporated
Celgene Corporation
Investigators
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Study Director: Solveig Ericson, MD Celularity Incorporated
More Information
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Responsible Party: Celularity Incorporated
ClinicalTrials.gov Identifier: NCT01155362    
Other Study ID Numbers: CCT-PDA001-002
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2014
Keywords provided by Celularity Incorporated:
Human Placenta-Derived Cells for the Treatment of Moderate-to-Severe Crohn's Disease
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases