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
1 other identifier
interventional
50
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2010
Typical duration for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2010
CompletedFirst Posted
Study publicly available on registry
July 1, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedJuly 22, 2020
July 1, 2014
1.5 years
May 26, 2010
July 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
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.
Week 4 (Day 29) and Week 6 (Day 43)
Secondary Outcomes (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)
Week 4 (Day 29) and Week 6 (Day 43)
Study Arms (4)
1 unit Human Placenta-Derived Cells PDA001
EXPERIMENTAL1 unit PDA001 in 240 millilters (mL) infused intravenously in one arm on Day 0 and Day 7.
4 units Human Placenta-Derived Cells PDA001
EXPERIMENTAL4 units PDA001 in 240 mL infused intravenously in one arm on Day 0 and Day 7.
vehicle control
PLACEBO COMPARATOR4 units placebo in 240 mL infused intravenously in one arm on Day 0 and Day 7.
8 units Human Placenta-Derived Cells PDA001
EXPERIMENTAL4 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
Interventions
Eligibility Criteria
You may qualify if:
- Males and females ages 18-75 years
- Understand and voluntarily sign an informed consent
- Able to adhere to the study visit schedule and other protocol requirements
- Minimum weight of 50 kg
- 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.
- Subject must have inflammatory CD 6 months prior to treatment and have confirmation of ongoing disease activity by colonoscopy or (other method) at screening
- Subject must have a CDAI score \> 220 and \< 450 as assessed between Visit 1 and Visit 2
- 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
You may not qualify if:
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
- 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:
- has not undergone a hysterectomy or bilateral oophorectomy
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celularity Incorporatedlead
- Celgene Corporationcollaborator
Study Sites (13)
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
University of California, Irvine
Orange, California, 92868, United States
Yale School of Medicine Digestive Diseases
New Haven, Connecticut, 06510, United States
University of Florida
Gainesville, Florida, 32610, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Indiana University
Indianapolis, Indiana, 46202-5149, United States
Mt Sinai Hospital
New York, New York, 10029, United States
Rochester General Hospital
Rochester, New York, 14621, United States
Stony Brook University
Stony Brook, New York, 11794-8173, United States
Case Western Reserve University
Cleveland, Ohio, 44106-5066, United States
Vanderbilt University
Nashville, Tennessee, 37212, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
McGuire VA Medical Center
Richmond, Virginia, 23249, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Solveig Ericson, MD
Celularity Incorporated
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2010
First Posted
July 1, 2010
Study Start
August 1, 2010
Primary Completion
February 1, 2012
Study Completion
April 1, 2014
Last Updated
July 22, 2020
Record last verified: 2014-07