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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01155362
• Other study ID #: CCT-PDA001-002
• Status: Completed
• Phase: Phase 2
• Start date: August 2010
• Est. completion date: April 2014

Study information

• Verified date: July 2014
• Source: Celularity Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2014
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• Human Placenta-Derived Cells PDA001 Intravenous Infusion

Drug:
• Vehice Control

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Case Western Reserve University	Cleveland	Ohio
United States	University of Florida	Gainesville	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Vanderbilt University	Nashville	Tennessee
United States	Yale School of Medicine Digestive Diseases	New Haven	Connecticut
United States	Mt Sinai Hospital	New York	New York
United States	University of California, Irvine	Orange	California
United States	McGuire VA Medical Center	Richmond	Virginia
United States	Rochester General Hospital	Rochester	New York
United States	Stony Brook University	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
Celularity Incorporated	Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	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.	Week 4 (Day 29) and Week 6 (Day 43)