Crohn's DiseasePhase 3NCT00543374
Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease
A Phase 3 study testing PROCHYMAL adult human mesenchymal stem cells in people with Crohn's Disease, run by Mesoblast, Inc. at 58 sites in 2 countries.
Trial summary
Protocol 610 is enrolling subjects who successfully achieved clinical benefit (reduction in Crohn's Disease Activity Index (CDAI) of at least 100 points) in Protocol 603. Protocol 610 is evaluating the length of initial effect of PROCHYMAL® adult human mesenchymal stem cells and the ability of these cells to… 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 adult human mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 58 sitesin 2 countries
- Study dates
- 17 Sep 2007to 28 Apr 2011
- 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
- Participation in Osiris Protocol 603, with drop of at least 100 points in CDAI at Day 28
Who cannot join
- Substance abuse
- Failure to receive full dose of all interventions in Protocol 603
Trial locations and contacts
58 sites in 2 countries.
58 sites in 2 countries
United States53 sites
Advanced Clinical Research Institute
Anaheim, California, 92801
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342
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
Gastroenterology Research Associates
Cedar Knolls, New Jersey, 07927
Charlotte Gastroenterology and Hepatology
Charlotte, North Carolina, 28207
Metropolitan Gastroenterology Group
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
Dayton Science Institute
Dayton, Ohio, 45415
Center for Clinical Studies
Dearborn, Michigan, 48124
University of Texas Medical Branch
Galveston, Texas, 77555
Gastroenterology Center of the Midsouth
Germantown, Tennessee, 37138
Gastroenterology Center of Connecticut
Hamden, Connecticut, 06518
Memorial Hermann Hospital
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
Veteran's Administration Medical Center (does not require vet status)
Long Beach, California, 90822
University of Southern California University Hospital
Los Angeles, California, 90033
University of Louisville Hospital
Louisville, Kentucky, 40202
Venture Research Institute
Miami, Florida, 33162
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
Holy Name Hospital
Teaneck, New Jersey, 07666
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 Sciences Centre
Winnipeg, Manitoba, R3A 1R9
About this study
Official title: A Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Durability and Retreatment Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Maintenance and Re-induction of Clinical Benefit and Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's Disease
Protocol 610 is enrolling subjects who successfully achieved clinical benefit (reduction in Crohn's Disease Activity Index (CDAI) of at least 100 points) in Protocol 603. Protocol 610 is evaluating the length of initial effect of PROCHYMAL® adult human mesenchymal stem cells and the ability of these cells to successfully re-induce clinical benefit.
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 610 is an extension study offered only to those subjects who successfully achieved clinical benefit (reduction of CDAI of at least 100 points) in Protocol 603.
- Conditions
- Crohn's Disease
- Being tested
- Placebo, PROCHYMAL adult human mesenchymal stem cells
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
PROCHYMAL adult human mesenchymal stem cellsDrug
intravenous infusion four times over two weeks; possibly repeated once
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| PROCHYMAL Low dose | Active comparator | Low dose (total of 600 million cells). Receives: Drug: PROCHYMAL adult human mesenchymal stem cells |
| PROCHYMAL High dose | Active comparator | High dose (total of 1200 cells). Receives: Drug: PROCHYMAL adult human mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of clinical benefit (Crohn's disease activity index)
Measured: 6 months
Re-induction of clinical benefit (Crohn's disease activity index)
Measured: 6 months
Secondary outcomes (1)
Improvement in quality of life (Inflammatory Bowel Disease Questionnaire [IBDQ] instrument)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2007 (estimated)
- Study start17 Sep 2007
- Primary completionJul 2009
- Study completion28 Apr 2011
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
- 98 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
- NCT00543374
- Sponsor's protocol ID
- CRD 610
- Status last verified
- Nov 2025
- First submitted
- 11 Oct 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 Durability and Retreatment Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Maintenance and Re-induction of Clinical Benefit and Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's Disease
- ClinicalTrials.gov ID
- NCT00543374
- Acronym / sponsor ID
- CRD 610
- Conditions
- Crohn's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Mesoblast, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Sep 2007 (actual)
- Primary completion
- Jul 2009 (actual)
- Study completion
- 28 Apr 2011 (actual)
- First posted
- 15 Oct 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 610 is enrolling subjects who successfully achieved clinical benefit (reduction in Crohn's Disease Activity Index (CDAI) of at least 100 points) in Protocol 603. Protocol 610 is evaluating the length of initial effect of PROCHYMAL® adult human mesenchymal stem cells and the ability of these cells to successfully re-induce clinical benefit.
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 610 is an extension study offered only to those subjects who successfully achieved clinical benefit (reduction of CDAI of at least 100 points) in Protocol 603.
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: PlaceboPlacebo |
| PROCHYMAL Low dose | Active comparator | Drug: PROCHYMAL adult human mesenchymal stem cellsLow dose (total of 600 million cells). |
| PROCHYMAL High dose | Active comparator | Drug: PROCHYMAL adult human mesenchymal stem cellsHigh dose (total of 1200 cells). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participation in Osiris Protocol 603, with drop of at least 100 points in CDAI at Day 28
Key exclusion criteria (2 listed)
- Substance abuse
- Failure to receive full dose of all interventions in Protocol 603
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 |
|---|---|---|
| Placebo | Drug | Placebo |
| PROCHYMAL adult human mesenchymal stem cellsintravenous infusion four times over two weeks; possibly repeated once | Drug | PROCHYMAL High dose, PROCHYMAL Low dose |
Primary outcome
Duration of clinical benefit (Crohn's disease activity index)
Time frame: 6 months
Re-induction of clinical benefit (Crohn's disease activity index)
Time frame: 6 months
1 secondary outcome
Improvement in quality of life (Inflammatory Bowel Disease Questionnaire [IBDQ] instrument)
Time frame: 6 months
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.
Christopher James, PA study director
Mesoblast, Inc.
58 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PROCHYMAL adult human mesenchymal stem cells in people with Crohn's Disease, run by Mesoblast, Inc. at 58 sites in 2 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 1 inclusion and 2 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 58 sites in United States, Canada. 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?
Duration of clinical benefit (Crohn's disease activity index) (time frame: 6 months). The study lists 2 primary outcomes in all. 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.