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Placenta cells could tame Crohn's inflammation

NCT ID NCT01155362

Disease control Sponsor: Celularity Incorporated Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This trial investigates whether intravenous infusions of cells from the human placenta (PDA001) can reduce inflammation and improve symptoms in adults with moderate-to-severe Crohn's disease. Participants receive either one of three doses of PDA001 or a placebo, and researchers track safety and effectiveness over time. The goal is to see if this cell-based approach offers a new way to control this chronic digestive condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
human placenta-derived cells (PDA001)
What this could lead to
If successful, this could point toward a new treatment option for people with moderate-to-severe Crohn's disease.
What could go wrong
This is an early Phase 2a study with only 50 participants, so results may not apply to everyone. The treatment may not work better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

50 people

The number who actually took part.

Start date

Aug 2010

Finished

Apr 2014

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn's disease

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Case Western Reserve University

    Cleveland, Ohio, 44106-5066, United States

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Indiana University

    Indianapolis, Indiana, 46202-5149, United States

  • McGuire VA Medical Center

    Richmond, Virginia, 23249, United States

  • Mt Sinai Hospital

    New York, New York, 10029, United States

  • Rochester General Hospital

    Rochester, New York, 14621, United States

  • Stony Brook University

    Stony Brook, New York, 11794-8173, United States

  • University of California, Irvine

    Orange, California, 92868, United States

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Florida

    Gainesville, Florida, 32610, United States

  • Vanderbilt University

    Nashville, Tennessee, 37212, United States

  • Yale School of Medicine Digestive Diseases

    New Haven, Connecticut, 06510, United States

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