Crohn's DiseasePhase 2NCT01155362
PDA001 for the Treatment of Adults With Moderate-to-Severe Crohn's Disease
A Phase 2 study testing Human Placenta-Derived Cells PDA001 Intravenous Infusion in people with Crohn's Disease, run by Celularity Incorporated at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Human Placenta-Derived Cells PDA001 Intravenous Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 13 sitesUnited States
- Study dates
- Aug 2010to Apr 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
- 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:
- has not undergone a hysterectomy or bilateral oophorectomy
- 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).
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Chicago Medical Center
Chicago, Illinois, 60637
Case Western Reserve University
Cleveland, Ohio, 44106-5066
University of Florida
Gainesville, Florida, 32610
Baylor College of Medicine
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202-5149
Cedars Sinai Medical Center
Los Angeles, California, 90048
Vanderbilt University
Nashville, Tennessee, 37212
Yale School of Medicine Digestive Diseases
New Haven, Connecticut, 06510
Mt Sinai Hospital
New York, New York, 10029
University of California, Irvine
Orange, California, 92868
McGuire VA Medical Center
Richmond, Virginia, 23249
Rochester General Hospital
Rochester, New York, 14621
Stony Brook University
Stony Brook, New York, 11794-8173
About this study
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Intravenous PDA001 for the Treatment of Adults With Moderate-to-Severe Crohn's Disease
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.
Read the detailed description
This was a Phase 2a, multicenter study designed to evaluate the safety, tolerability, and efficacy of intravenous human placenta-derived cells (PDA001) in adults with moderate-to-severe Crohn's disease.
The study consisted of sequential cohorts. Initial open-label dose-escalation cohorts evaluated PDA001 administered intravenously at a dose of 1.6 × 10^9 cells (8 units). A subsequent randomized, double-blind, placebo-controlled cohort evaluated PDA001 administered intravenously at doses of 200 × 10^6 cells (1 unit) and 800 × 10^6 cells (4 units) compared with placebo.
The primary efficacy objective was to evaluate induction of clinical response, defined as a reduction from baseline of 25% and/or at least 100 points in the Crohn's Disease Activity Index (CDAI) at both Week 4 and Week 6. Secondary objectives included evaluation of clinical remission, safety, and tolerability.
Subjects were followed during an induction phase and could participate in an extension phase with re-treatment according to protocol-defined criteria.
- Conditions
- Crohn's Disease
- Being tested
- Human Placenta-Derived Cells PDA001 Intravenous Infusion, Vehicle Control
- Keywords
- Human Placenta-Derived Cells, Crohns disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Placenta-Derived Cells PDA001 Intravenous InfusionBiological
Vehicle ControlDrug
Also called Placebo
| Study group | Role | What they receive |
|---|---|---|
| 200 × 10^6 cells of Human Placenta-Derived Cells PDA001 | Experimental | PDA001 administered intravenously at a dose of 1 unit, approximately 200 × 10^6 cells, on Study Day 0 and Study Day 7. Receives: Biological: Human Placenta-Derived Cells PDA001 Intravenous Infusion |
| 800 × 10^6 cells of Human Placenta-Derived Cells PDA001 | Experimental | PDA001 administered intravenously at a dose of 4 units, approximately 800 × 10^6 cells, on Study Day 0 and Study Day 7. Receives: Biological: Human Placenta-Derived Cells PDA001 Intravenous Infusion |
| vehicle control | Placebo comparator | Matching placebo administered intravenously on Study Day 0 and Study Day 7. Receives: Drug: Vehicle Control |
| 1.6 × 10^9 cells of Human Placenta-Derived Cells PDA001 | Experimental | PDA001 administered intravenously at a dose of 8 units, approximately 1.6 × 10^9 cells, on Study Day 0 and Study Day 7. Receives: Biological: Human Placenta-Derived Cells PDA001 Intravenous Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Clinical Response Based on Crohn's Disease Activity Index (CDAI) at Both Week 4 and Week 6
Clinical response was defined as a reduction from baseline of at least 25% and/or at least 100 points in the Crohn's Disease Activity Index (CDAI) score at both Week 4 (Day 29) and Week 6 (Day 43). The Crohn's Disease Activity Index (CDAI) is a composite clinical index used to assess disease activity in Crohn's disease based on clinical signs, symptoms, and laboratory findings. Scores range from approximately 0 to 600, with higher scores indicating more severe disease activity and lower scores indicating less severe disease activity. Scores of 150 or less generally indicate clinical remission, whereas scores greater than 450 indicate very severe disease activity.
Measured: Week 4 (Day 29) and Week 6 (Day 43)
Secondary outcomes (1)
Percentage of Subjects With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) at Both Week 4 and Week 6
Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of 150 or less at both Week 4 (Day 29) and Week 6 (Day 43). The Crohn's Disease Activity Index (CDAI) is a composite clinical index used to assess disease activity in Crohn's disease based on clinical signs, symptoms, and laboratory findings. Scores range from approximately 0 to 600, with higher scores indicating more severe disease activity and lower scores indicating less severe disease activity. Scores of 150 or less generally indicate clinical remission, whereas scores greater than 450 indicate very severe disease activity.
Measured: Week 4 (Day 29) and Week 6 (Day 43)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionFeb 2012
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study included sequential cohorts. Initial open-label dose-escalation cohorts evaluated PDA001 1.6 × 10\^9 cells (8 units). A subsequent randomized, double-blind, placebo-controlled cohort evaluated PDA001 200 × 10\^6 cells (1 unit), PDA001 800 × 10\^6 cells (4 units), and placebo in parallel treatment groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celularity Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- sharmila koppisetti, MD, Study director, Celularity Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155362
- Sponsor's protocol ID
- CCT-PDA001-002
- Status last verified
- Jul 2026
- First submitted
- 26 May 2010
- Last updated
- 7 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Melmed GY, Pandak WM, Casey K, Abraham B, Valentine J, Schwartz D, Awais D, Bassan I, Lichtiger S, Sands B, Hanauer S, Richards R, Oikonomou I, Parekh N, Targan S, Johnson K, Hariri R, Fischkoff S. Human Placenta-derived Cells (PDA-001) for the Treatment of Moderate-to-severe Crohn's Disease: A Phase 1b/2a Study. Inflamm Bowel Dis. 2015 Aug;21(8):1809-16. doi: 10.1097/MIB.0000000000000441.
PubMed 25985246
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Intravenous PDA001 for the Treatment of Adults With Moderate-to-Severe Crohn's Disease
- ClinicalTrials.gov ID
- NCT01155362
- Acronym / sponsor ID
- CCT-PDA001-002
- Conditions
- Crohn's Disease
- Keywords
- Human Placenta-Derived Cells, Crohns disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Celularity IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- Celgene Corporation
- Study start
- Aug 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 1 Jul 2010 (estimated)
- Results
- Posted 7 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This was a Phase 2a, multicenter study designed to evaluate the safety, tolerability, and efficacy of intravenous human placenta-derived cells (PDA001) in adults with moderate-to-severe Crohn's disease.
The study consisted of sequential cohorts. Initial open-label dose-escalation cohorts evaluated PDA001 administered intravenously at a dose of 1.6 × 10^9 cells (8 units). A subsequent randomized, double-blind, placebo-controlled cohort evaluated PDA001 administered intravenously at doses of 200 × 10^6 cells (1 unit) and 800 × 10^6 cells (4 units) compared with placebo.
The primary efficacy objective was to evaluate induction of clinical response, defined as a reduction from baseline of 25% and/or at least 100 points in the Crohn's Disease Activity Index (CDAI) at both Week 4 and Week 6. Secondary objectives included evaluation of clinical remission, safety, and tolerability.
Subjects were followed during an induction phase and could participate in an extension phase with re-treatment according to protocol-defined criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The study included sequential cohorts. Initial open-label dose-escalation cohorts evaluated PDA001 1.6 × 10^9 cells (8 units). A subsequent randomized, double-blind, placebo-controlled cohort evaluated PDA001 200 × 10^6 cells (1 unit), PDA001 800 × 10^6 cells (4 units), and placebo in parallel treatment groups.
| Arm | Type | Receives |
|---|---|---|
| 200 × 10^6 cells of Human Placenta-Derived Cells PDA001 | Experimental | Biological: Human Placenta-Derived Cells PDA001 Intravenous InfusionPDA001 administered intravenously at a dose of 1 unit, approximately 200 × 10^6 cells, on Study Day 0 and Study Day 7. |
| 800 × 10^6 cells of Human Placenta-Derived Cells PDA001 | Experimental | Biological: Human Placenta-Derived Cells PDA001 Intravenous InfusionPDA001 administered intravenously at a dose of 4 units, approximately 800 × 10^6 cells, on Study Day 0 and Study Day 7. |
| vehicle control | Placebo comparator | Drug: Vehicle ControlMatching placebo administered intravenously on Study Day 0 and Study Day 7. |
| 1.6 × 10^9 cells of Human Placenta-Derived Cells PDA001 | Experimental | Biological: Human Placenta-Derived Cells PDA001 Intravenous InfusionPDA001 administered intravenously at a dose of 8 units, approximately 1.6 × 10^9 cells, on Study Day 0 and Study Day 7. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
- Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- has not undergone a hysterectomy or bilateral oophorectomy
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Placenta-Derived Cells PDA001 Intravenous Infusion | Biological | 1.6 × 10^9 cells of Human Placenta-Derived Cells PDA001, 200 × 10^6 cells of Human Placenta-Derived Cells PDA001, 800 × 10^6 cells of Human Placenta-Derived Cells PDA001 |
| Vehicle ControlAlso: Placebo | Drug | vehicle control |
Primary outcome
Percentage of Subjects With Clinical Response Based on Crohn's Disease Activity Index (CDAI) at Both Week 4 and Week 6
Time frame: Week 4 (Day 29) and Week 6 (Day 43)
Clinical response was defined as a reduction from baseline of at least 25% and/or at least 100 points in the Crohn's Disease Activity Index (CDAI) score at both Week 4 (Day 29) and Week 6 (Day 43). The Crohn's Disease Activity Index (CDAI) is a composite clinical index used to assess disease activity in Crohn's disease based on clinical signs, symptoms, and laboratory findings. Scores range from approximately 0 to 600, with higher scores indicating more severe disease activity and lower scores indicating less severe disease activity. Scores of 150 or less generally indicate clinical remission, whereas scores greater than 450 indicate very severe disease activity.
1 secondary outcome
Percentage of Subjects With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) at Both Week 4 and Week 6
Time frame: Week 4 (Day 29) and Week 6 (Day 43)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25985246Melmed GY, Pandak WM, Casey K, Abraham B, Valentine J, Schwartz D, Awais D, Bassan I, Lichtiger S, Sands B, Hanauer S, Richards R, Oikonomou I, Parekh N, Targan S, Johnson K, Hariri R, Fischkoff S. Human Placenta-derived Cells (PDA-001) for the Treatment of Moderate-to-severe Crohn's Disease: A Phase 1b/2a Study. Inflamm Bowel Dis. 2015 Aug;21(8):1809-16. doi: 10.1097/MIB.0000000000000441.
- PDA-001 for treatment of Crohns diseaseLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sharmila koppisetti, MD study director
Celularity Incorporated
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Human Placenta-Derived Cells PDA001 Intravenous Infusion in people with Crohn's Disease, run by Celularity Incorporated at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects With Clinical Response Based on Crohn's Disease Activity Index (CDAI) at Both Week 4 and Week 6 (time frame: Week 4 (Day 29) and Week 6 (Day 43)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01155362, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.