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

Status:	Completed
Conditions:	Gastrointestinal, Crohns Disease
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - 75
Updated:	2/23/2019
Start Date:	August 2010
End Date:	April 2014

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

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.

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).

We found this trial at

sites

University of Florida

Gainesville, Florida 32610

(352) 392-3261