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

Use our guide to learn which trials are right for you!

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
13
sites
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
?
mi
from
Houston, TX
Click here to add this to my saved trials
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Haven, Connecticut 06510
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New York, New York 10029
?
mi
from
New York, NY
Click here to add this to my saved trials
Orange, California 92868
?
mi
from
Orange, CA
Click here to add this to my saved trials
Richmond, Virginia 23249
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Rochester, New York 14621
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Stony Brook, New York 11794
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials