Crohn's DiseasePhase 3NCT01233960
Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease
A Phase 3 study testing Prochymal® in people with Crohn's Disease, run by Mesoblast, Inc. at 20 sites in 3 countries.
Trial summary
To provide open-label re-treatment with PROCHYMAL to participants enrolled in companion Protocol 603 to evaluate the safety in participants with active Crohn's disease who are resistant to standard Crohn's disease therapies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Prochymal®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 20 sitesin 3 countries
- Study dates
- 29 Nov 2010to 15 Sep 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must have qualified for, enrolled in, and provided written informed consent form (ICF) and authorization for use and disclosure of protected health information (PHI) for Protocol 603 after the August 3, 2010.
- Participant successfully completed all screening assessments in Protocol 603 as required by Protocol 603.
- Participant successfully completed the full course of each of the four infusions of investigational agent on Days 0, 3, 7, and 14 of Protocol 603 after August 3, 2010.
- Participant must enroll in Protocol 611 on or before the 45th day after first infusion in Protocol 603.
- Participant must provide written ICF and authorization for use and disclosure of PHI for Protocol 611.
Who cannot join
- Participant is unwilling or unable to adhere to requirements of Protocol 611.
- Participant had confirmed respiratory distress during a PROCHYMAL infusion in any prior PROCHYMAL study.
- Participant had a serious adverse event in any previous PROCHYMAL study that was deemed by the principal investigator of that study to be possibly or probably related to PROCHYMAL and also that was within 48 h after a PROCHYMAL infusion.
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
United States16 sites
University of Maryland, Baltimore
Baltimore, Maryland, 21201
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
University of Chicago
Chicago, Illinois, 60611
Clinical Research of West Florida
Clearwater, Florida, 33765
Baylor University Medical Center
Dallas, Texas, 75246
Gastroenterology Center of the Midsouth, PC
Germantown, Tennessee, 38138
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Weill Cornell Medical College
New York, New York, 10028
Mount Sinai School of Medicine
New York, New York, 10029
McGuire Research Institute
Richmond, Virginia, 23249
University of California, San Francisco
San Francisco, California, 94115
Saint Louis Center for Clinical Research
St Louis, Missouri, 63128
St. Louis Center for Clinical Studies
St Louis, Missouri, 63128
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, 66606
Shafran Gastroenterology Center
Winter Park, Florida, 32789
Australia2 sites
Royal Adelaide Hospital
Adelaide, South Australia
Royal Melbourne Hospital
Melbourne, Victoria
New Zealand2 sites
University of Otago
Christchurch
Waikato Hospital
Hamilton
About this study
Official title: A Multicenter, Open-label Study to Evaluate the Safety of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects Who Have Received Previous Remestemcel-L Induction Treatment for Treatment-refractory Moderate-to-severe Crohn's Disease
To provide open-label re-treatment with PROCHYMAL to participants enrolled in companion Protocol 603 to evaluate the safety in participants with active Crohn's disease who are resistant to standard Crohn's disease therapies.
Read the detailed description
Participants will receive infusions of PROCHYMAL on Day 42, Day 84, and Day 126 after initial infusion of PROCHYMAL in Protocol 603. Each infusion will contain 200 million cells. As participants will be required to be in Protocol 603 during the entire duration of their participation in Protocol 611, all concomitant medication and safety information will be monitored by Protocol 603 and the combination of data from the two protocols.
- Conditions
- Crohn's Disease
- Being tested
- Prochymal®
- Keywords
- Crohn's Disease, Adult Stem Cell Therapy, inflammation of the gastrointestinal tract
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prochymal®Drug
Also called Adult human mesenchymal stem cells, Remestemcel-L
PROCHYMAL will be administered IV in a total volume of 300 ml (200 million cells) at a rate of 4-6 ml/minute. Treatments will be administered on Days 42-45, Days 84-87, and Days 126-129 following first infusion in Protocol 603.
| Study group | Role | What they receive |
|---|---|---|
| Prochymal® | Experimental | Infusions of Prochymal on days 42-45, 84-87, and 126-129 after first infusion in Protocol 603. Each infusion of PROCHYMAL (remestemcel-L) will contain 200 million cells. Receives: Drug: Prochymal® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease remission
Crohn's Disease Activity Index (CDAI) at or below 150 and increase in IBDQ
Measured: 180 Days after first infusion in Protocol 603
Secondary outcomes (4)
Disease Improvement
CDAI response to treatments is defined as a CDAI of 150 or below, or a reduction in CDAI of at least 100 points.
Measured: 180 Days after first infusion in Protocol 603
Improvement in Quality of Life (IBDQ)
IBDQ response to treatment is defined as IBDQ of 170 or above, or an increase in IBDQ of at least 16 points.
Measured: 180 Days after first infusion in Protocol 603
Number of Adverse events as a measure of safety
Measured: 180 Days after first infusion in Protocol 603
Infusional toxicity as a measure of safety and tolerability
Infusional toxicity will be evaluated by continuously monitoring the subject's vital signs and O2 saturation by pulse oximetry from the time of PROCHYMAL administration until two hours after infusion is complete.
Measured: 180 Days after first infusion in Protocol 603
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study start29 Nov 2010
- Primary completion15 Sep 2014
- Study completion15 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesoblast, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher James, PA, Study director, Mesoblast, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233960
- Sponsor's protocol ID
- CRD 611
- Status last verified
- Nov 2025
- First submitted
- 2 Nov 2010
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Study to Evaluate the Safety of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects Who Have Received Previous Remestemcel-L Induction Treatment for Treatment-refractory Moderate-to-severe Crohn's Disease
- ClinicalTrials.gov ID
- NCT01233960
- Acronym / sponsor ID
- CRD 611
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, Adult Stem Cell Therapy, inflammation of the gastrointestinal tract
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Mesoblast, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2010 (actual)
- Primary completion
- 15 Sep 2014 (actual)
- Study completion
- 15 Sep 2014 (actual)
- First posted
- 3 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To provide open-label re-treatment with PROCHYMAL to participants enrolled in companion Protocol 603 to evaluate the safety in participants with active Crohn's disease who are resistant to standard Crohn's disease therapies.
Detailed description
Participants will receive infusions of PROCHYMAL on Day 42, Day 84, and Day 126 after initial infusion of PROCHYMAL in Protocol 603. Each infusion will contain 200 million cells. As participants will be required to be in Protocol 603 during the entire duration of their participation in Protocol 611, all concomitant medication and safety information will be monitored by Protocol 603 and the combination of data from the two protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prochymal® | Experimental | Drug: Prochymal®Infusions of Prochymal on days 42-45, 84-87, and 126-129 after first infusion in Protocol 603. Each infusion of PROCHYMAL (remestemcel-L) will contain 200 million cells. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant must have qualified for, enrolled in, and provided written informed consent form (ICF) and authorization for use and disclosure of protected health information (PHI) for Protocol 603 after the August 3, 2010.
- Participant successfully completed all screening assessments in Protocol 603 as required by Protocol 603.
- Participant successfully completed the full course of each of the four infusions of investigational agent on Days 0, 3, 7, and 14 of Protocol 603 after August 3, 2010.
- Participant must enroll in Protocol 611 on or before the 45th day after first infusion in Protocol 603.
- Participant must provide written ICF and authorization for use and disclosure of PHI for Protocol 611.
Key exclusion criteria (3 listed)
- Participant is unwilling or unable to adhere to requirements of Protocol 611.
- Participant had confirmed respiratory distress during a PROCHYMAL infusion in any prior PROCHYMAL study.
- Participant had a serious adverse event in any previous PROCHYMAL study that was deemed by the principal investigator of that study to be possibly or probably related to PROCHYMAL and also that was within 48 h after a PROCHYMAL infusion.
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 |
|---|---|---|
| Prochymal®Also: Adult human mesenchymal stem cells, Remestemcel-LPROCHYMAL will be administered IV in a total volume of 300 ml (200 million cells) at a rate of 4-6 ml/minute. Treatments will be administered on Days 42-45, Days 84-87, and Days 126-129 following first infusion in Protocol 603. | Drug | Prochymal® |
Primary outcome
Disease remission
Time frame: 180 Days after first infusion in Protocol 603
Crohn's Disease Activity Index (CDAI) at or below 150 and increase in IBDQ
4 secondary outcomes
Disease Improvement
Time frame: 180 Days after first infusion in Protocol 603
Improvement in Quality of Life (IBDQ)
Time frame: 180 Days after first infusion in Protocol 603
Number of Adverse events as a measure of safety
Time frame: 180 Days after first infusion in Protocol 603
Infusional toxicity as a measure of safety and tolerability
Time frame: 180 Days after first infusion in Protocol 603
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
Related trials for Crohn's Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
Christopher James, PA study director
Mesoblast, Inc.
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prochymal® in people with Crohn's Disease, run by Mesoblast, Inc. at 20 sites in 3 countries.
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 5 inclusion and 3 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 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Australia, New Zealand. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disease remission (time frame: 180 Days after first infusion in Protocol 603). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2026.