Crohn's DiseasePhase 3NCT00482092
Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease
A Phase 3 study testing Prochymal® in people with Crohn's Disease, run by Mesoblast, Inc. at 56 sites in 4 countries.
Trial summary
Protocol 603 is enrolling subjects with moderate-to-severe Crohn's disease who are intolerant to, or have previously failed therapy with, at least one steroid and at least one immunosuppressant and a biologic monoclonal anti-body to tumor necrosis factor alpha. 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?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 56 sitesin 4 countries
- Study dates
- 17 Sep 2007to 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
- failed (within last 2 yr) or intolerant of at least one steroid AND at least one immunosuppressant AND at EXACTLY one biologic
- CDAI between 250 and 450, inclusive
- endoscopically or radiographically confirmed Crohn's disease of ileus or colon or both
- C-Reactive Protein Test (CRP) of at least 5 mg/l (0.5 mg/dl)*OR* CDAI of at least 300
- weight between 40 and 150 kg, inclusive
- adequate renal function
- negative tuberculosis skin (PPD) test (or evaluated low risk of TB activation)
Who cannot join
- HIV or hepatitis infection active
- allergy to CT contrast agents, or to bovine or porcine products
- symptomatic fibrostenotic Crohn's disease
- permanent ostomy
- biologic therapy within past 90 d
- prednisone greater than 20 mg/d within past month
Show all 13Show fewer
- short-bowel syndrome
- total parenteral nutrition
- abnormal liver function
- malignancy active within past 5 years (except completely resected basal or squamous cell carcinoma of skin)
- enteric pathogens, including C. difficile
- history of colonic mucosal dysplasia
- current or prior evidence of tuberculosis (TB) (unless risk of activation or re-activation deemed low)
Trial locations and contacts
56 sites in 4 countries.
56 sites in 4 countries
United States47 sites
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342
University of Maryland, Baltimore
Baltimore, Maryland, 21201
Gulf Coast Research
Baton Rouge, Louisiana, 70808
National Institutes of Health
Bethesda, Maryland, 20892
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Womens Hospital
Boston, Massachusetts, 02115
University of Vermont
Burlington, Vermont, 05401
Charlotte Gastroenterology and Hepatology
Charlotte, North Carolina, 28207
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
University of Chicago Medical Center
Chicago, Illinois, 60637
Clinical Research of West Florida
Clearwater, Florida, 33765
Baylor University Medical Center
Dallas, Texas, 75246
Center for Clinical Studies
Dearborn, Michigan, 48124
University of Texas Medical Branch
Galveston, Texas, 77555
Gastroenterology Center of the Midsouth
Germantown, Tennessee, 37138
University of Texas Health Science Center
Houston, Texas, 77030
Indiana University Medical Center
Indianapolis, Indiana, 46202
Borland-Groover Clinic
Jacksonville, Florida, 32256
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Kentucky Hospital
Lexington, Kentucky, 40536
University of Southern California University Hospital
Los Angeles, California, 90033
University of Louisville Hospital
Louisville, Kentucky, 40202
University of Minnesota Hospital
Minneapolis, Minnesota, 55455
Nashville GI Specialists
Nashville, Tennessee, 37205
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
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502
Pinehurst Medical Clinic
Pinehurst, North Carolina, 28734
Allegheney Center for Digestive Health
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
McGuire Research Institute
Richmond, Virginia, 23249
Rochester Institute for Digestive Diseases
Rochester, New York, 14607
Rochester General Hospital
Rochester, New York, 14621
University of California, San Francisco
San Francisco, California, 94115
Seattle Gastroenterology Associates
Seattle, Washington, 98133
St Louis Center for Clinical Studies
St Louis, Missouri, 63128
University Hospital and Medical Center
Stony Brook, New York, 11794
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, 66606
Center for Digestive Health
Troy, Michigan, 48098
Gastroenterology United of Tulsa
Tulsa, Oklahoma, 74135
Options Health Research
Tulsa, Oklahoma, 74137
Carle Clinic Association
Urbana, Illinois, 61801
Western States Clinical Research
Wheat Ridge, Colorado, 80033
Wake Forest University
Winston-Salem, North Carolina, 27157
Shafran Gastroenterology Center
Winter Park, Florida, 32789
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610
Canada5 sites
University of Calgary
Calgary, Alberta, T2N 4N1
University of Alberta Hospital
Edmonton, Alberta, T6G 2X8
London Health Sciences Centre
London, Ontario, N6A 5A5
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Health Science Centre
Winnipeg, Manitoba, R3A 1R9
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 Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Induction of Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's Disease
Protocol 603 is enrolling subjects with moderate-to-severe Crohn's disease who are intolerant to, or have previously failed therapy with, at least one steroid and at least one immunosuppressant and a biologic monoclonal anti-body to tumor necrosis factor alpha. The protocol investigates the safety and efficacy of using PROCHYMAL® adult human stem cells to induce remission. PROCHYMAL is delivered through a vein in the arm four times over two weeks, for approximately an hour each time.
Read the detailed description
A significant number of individuals with Crohn's disease do not find relief with existing steroidal, immunosuppressive, or biologic therapies, and are forced to seek surgery or other drastic measures for treatment.
PROCHYMAL® adult human stem cells are manufactured from healthy, volunteer donors, extensively tested, and are stored to be available as needed. Human and animal studies have shown that the cells do not require any donor-recipient matching. The cells may have both immunosuppressive and healing benefits in Crohn's disease. The cells naturally migrate specifically to sites of inflammation, so their effects are believed to be local and self-limiting rather than systemic.
Protocol 603 is enrolling subjects to evaluate the ability of PROCHYMAL to induce remission in subjects with moderate-to-severe disease (Crohn's disease activity index -- CDAI -- of between 250 and 450, inclusive) who have failed or been intolerant of at least one drug in each of the steroid, immunosuppressant, and biologic classes.
- Conditions
- Crohn's Disease
- Being tested
- Prochymal®, Placebo
- Keywords
- Crohn's disease, adult stem cell therapy
- 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
Prochymal® IV infusion
PlaceboDrug
Prochymal® Placebo-matching IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will receive matching placebo administered as intravenous (IV) infusions. Receives: Drug: Placebo |
| Prochymal® - Low dose | Active comparator | Participants will receive a total dose of Prochymal® 600 x 10^6 cells, IV infusion, on four days, once daily. Receives: Drug: Prochymal® |
| Prochymal® - High dose | Active comparator | Participants will receive a total dose of Prochymal® 1200 x 10^6 cells, IV infusion, on four days, once daily. Receives: Drug: Prochymal® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease remission (CDAI at or below 150)
Measured: 28 days
Secondary outcomes (3)
Disease improvement (Reduction by at least 100 points in CDAI)
Measured: 28 days
Improvement in quality of life (IBDQ)
Measured: 28 days
Reduction in number of draining fistulas
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2007 (estimated)
- Study start17 Sep 2007
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesoblast, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahboob Rahman, MD, Study director, Mesoblast, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482092
- Sponsor's protocol ID
- CRD 603
- Status last verified
- Nov 2025
- First submitted
- 30 May 2007
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Induction of Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's Disease
- ClinicalTrials.gov ID
- NCT00482092
- Acronym / sponsor ID
- CRD 603
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, adult stem cell therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Mesoblast, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Sep 2007 (actual)
- Primary completion
- 15 Sep 2014 (actual)
- Study completion
- 15 Sep 2014 (actual)
- First posted
- 4 Jun 2007 (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.
Protocol 603 is enrolling subjects with moderate-to-severe Crohn's disease who are intolerant to, or have previously failed therapy with, at least one steroid and at least one immunosuppressant and a biologic monoclonal anti-body to tumor necrosis factor alpha. The protocol investigates the safety and efficacy of using PROCHYMAL® adult human stem cells to induce remission. PROCHYMAL is delivered through a vein in the arm four times over two weeks, for approximately an hour each time.
Detailed description
A significant number of individuals with Crohn's disease do not find relief with existing steroidal, immunosuppressive, or biologic therapies, and are forced to seek surgery or other drastic measures for treatment.
PROCHYMAL® adult human stem cells are manufactured from healthy, volunteer donors, extensively tested, and are stored to be available as needed. Human and animal studies have shown that the cells do not require any donor-recipient matching. The cells may have both immunosuppressive and healing benefits in Crohn's disease. The cells naturally migrate specifically to sites of inflammation, so their effects are believed to be local and self-limiting rather than systemic.
Protocol 603 is enrolling subjects to evaluate the ability of PROCHYMAL to induce remission in subjects with moderate-to-severe disease (Crohn's disease activity index -- CDAI -- of between 250 and 450, inclusive) who have failed or been intolerant of at least one drug in each of the steroid, immunosuppressant, and biologic classes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo administered as intravenous (IV) infusions. |
| Prochymal® - Low dose | Active comparator | Drug: Prochymal®Participants will receive a total dose of Prochymal® 600 x 10^6 cells, IV infusion, on four days, once daily. |
| Prochymal® - High dose | Active comparator | Drug: Prochymal®Participants will receive a total dose of Prochymal® 1200 x 10^6 cells, IV infusion, on four days, once daily. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- failed (within last 2 yr) or intolerant of at least one steroid AND at least one immunosuppressant AND at EXACTLY one biologic
- CDAI between 250 and 450, inclusive
- endoscopically or radiographically confirmed Crohn's disease of ileus or colon or both
- C-Reactive Protein Test (CRP) of at least 5 mg/l (0.5 mg/dl)*OR* CDAI of at least 300
- weight between 40 and 150 kg, inclusive
Key exclusion criteria (13 listed)
- HIV or hepatitis infection active
- allergy to CT contrast agents, or to bovine or porcine products
- symptomatic fibrostenotic Crohn's disease
- permanent ostomy
- biologic therapy within past 90 d
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 CellsProchymal® IV infusion | Drug | Prochymal® - High dose, Prochymal® - Low dose |
| PlaceboProchymal® Placebo-matching IV infusion | Drug | Placebo |
Primary outcome
Disease remission (CDAI at or below 150)
Time frame: 28 days
3 secondary outcomes
Disease improvement (Reduction by at least 100 points in CDAI)
Time frame: 28 days
Improvement in quality of life (IBDQ)
Time frame: 28 days
Reduction in number of draining fistulas
Time frame: 28 days
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.
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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.
Mahboob Rahman, MD study director
Mesoblast, Inc.
56 sites in 4 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 56 sites in 4 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 7 inclusion and 13 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 56 sites in United States, Canada, 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. 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 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 (CDAI at or below 150) (time frame: 28 days). 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.