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

Tracking Information
First Submitted Date ICMJE	May 26, 2010
First Posted Date ICMJE	July 1, 2010
Last Update Posted Date	March 2, 2018
Study Start Date ICMJE	August 2010
Actual Primary Completion Date	February 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 14, 2014)	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.
Original Primary Outcome Measures ICMJE; (submitted: June 30, 2010)	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) ]
Change History	Complete list of historical versions of study NCT01155362 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 14, 2014)	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.
Original Secondary Outcome Measures ICMJE; (submitted: June 30, 2010)	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) ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	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
Official Title ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Crohn's Disease
Intervention ICMJE	Biological: Human Placenta-Derived Cells PDA001 Intravenous Infusion; Drug: Vehice Control Other Name: Placebo
Study Arms	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. Intervention: 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. Intervention: 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. Intervention: Drug: Vehice Control
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 25, 2012)	50
Original Estimated Enrollment ICMJE; (submitted: June 30, 2010)	52
Actual Study Completion Date	April 2014
Actual Primary Completion Date	February 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 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 Exclusion Criteria: 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).
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 75 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01155362
Other Study ID Numbers ICMJE	CCT-PDA001-002
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Celularity Incorporated
Study Sponsor ICMJE	Celularity Incorporated
Collaborators ICMJE	Celgene Corporation
Investigators ICMJE	Study Director: Monica E Luchi, MD Celularity Incorporated
PRS Account	Celularity Incorporated
Verification Date	July 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP