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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT01155362•Celularity Incorporated

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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).

Locations (13)

Cedars Sinai Medical Center

Los Angeles, California, United States

University of California, Irvine

Orange, California, United States

Yale School of Medicine Digestive Diseases

New Haven, Connecticut, United States

University of Florida

Gainesville, Florida, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

Mt Sinai Hospital

New York, New York, United States

Rochester General Hospital

Rochester, New York, United States

Stony Brook University

Stony Brook, New York, United States

Case Western Reserve University

Cleveland, Ohio, United States

Key Dates

Start Date

August 1, 2010

Primary Completion Date

February 1, 2012

Completion Date

April 1, 2014

Last Updated

July 22, 2020

Enrollment

ACTUAL participants

Conditions

Crohn's Disease

Interventions

Human Placenta-Derived Cells PDA001 Intravenous Infusion

BIOLOGICAL

Vehice Control

DRUG

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

View study

RECRUITINGPHASE3

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

NCT07184931

Crohn's Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 22, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

Prophylactic Dexamethasone Before Infliximab in Moderate-to-Severe IBD

A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease

Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease