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
NCT ID: NCT01155362
Last Updated: 2020-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2010-08-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Human Placenta-Derived Cells PDA001 Intravenous Infusion
4 units Human Placenta-Derived Cells PDA001
4 units PDA001 in 240 mL infused intravenously in one arm on Day 0 and Day 7.
Human Placenta-Derived Cells PDA001 Intravenous Infusion
vehicle control
4 units placebo in 240 mL infused intravenously in one arm on Day 0 and Day 7.
Vehice Control
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
Human Placenta-Derived Cells PDA001 Intravenous Infusion
Interventions
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Human Placenta-Derived Cells PDA001 Intravenous Infusion
Vehice Control
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
75 Years
ALL
No
Sponsors
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Celgene Corporation
INDUSTRY
Celularity Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Solveig Ericson, MD
Role: STUDY_DIRECTOR
Celularity Incorporated
Locations
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Cedars Sinai Medical Center
Los Angeles, California, United States
University of California, Irvine
Orange, California, United States
Yale School of Medicine Digestive Diseases
New Haven, Connecticut, United States
University of Florida
Gainesville, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Mt Sinai Hospital
New York, New York, United States
Rochester General Hospital
Rochester, New York, United States
Stony Brook University
Stony Brook, New York, United States
Case Western Reserve University
Cleveland, Ohio, United States
Vanderbilt University
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
McGuire VA Medical Center
Richmond, Virginia, United States
Countries
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Other Identifiers
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CCT-PDA001-002
Identifier Type: -
Identifier Source: org_study_id
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