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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01155362
• Date of registration: 26/05/2010
• Prospective Registration: Yes
• Primary sponsor: Celularity Incorporated
• Public title: 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
• Scientific 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
• Date of first enrolment: August 2010
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01155362
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Solveig Ericson, MD
• Affiliation: Celularity Incorporated

Key inclusion & exclusion criteria

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).



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Biological: Human Placenta-Derived Cells PDA001 Intravenous Infusion

Drug: Vehice Control

Primary Outcome(s)

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)]

Secondary Outcome(s)

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)]

Secondary ID(s)

CCT-PDA001-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Celgene Corporation