CompletedPhase 2

PDA001 for the Treatment of Adults With Moderate-to-Severe Crohn's Disease

United States50 participantsStarted 2010-08

Plain-language summary

This Phase 2a study evaluated the efficacy, safety, and tolerability of intravenous human placenta-derived cells (PDA001) compared with placebo in adults with moderate-to-severe Crohn's disease. Three PDA001 dose levels were evaluated.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Males and females ages 18-75 years
. Understand and voluntarily sign an informed consent
. Able to adhere to the study visit schedule and other protocol requirements
. Minimum weight of 50 kg
. 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.
. Subject must have inflammatory CD 6 months prior to treatment and have confirmation of ongoing disease activity by colonoscopy or (other method) at screening
. Subject must have a CDAI score \> 220 and \< 450 as assessed between Visit 1 and Visit 2
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Subjects With Clinical Response Based on Crohn's Disease Activity Index (CDAI) at Both Week 4 and Week 6

Timeframe: Week 4 (Day 29) and Week 6 (Day 43)

Trial details

NCT IDNCT01155362

SponsorCelularity Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-02

Results submitted2026-06-02

View on ClinicalTrials.gov More Crohn's Disease trials