Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease
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ClinicalTrials.gov Identifier: NCT00482092 |
Recruitment Status :
Completed
First Posted : June 4, 2007
Last Update Posted : January 13, 2022
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Condition or disease | Intervention/treatment | Phase |
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Crohn's Disease | Drug: Prochymal® Drug: Placebo | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 330 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | September 17, 2007 |
Actual Primary Completion Date : | September 15, 2014 |
Actual Study Completion Date : | September 15, 2014 |

Arm | Intervention/treatment |
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Placebo Comparator: Placebo
Participants will receive matching placebo administered as intravenous (IV) infusions.
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Drug: Placebo
Prochymal® Placebo-matching IV infusion |
Active Comparator: Prochymal® - Low dose
Participants will receive a total dose of Prochymal® 600 x 10^6 cells, IV infusion, on four days, once daily.
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Drug: Prochymal®
Prochymal® IV infusion
Other Name: Adult Human Mesenchymal Stem Cells |
Active Comparator: Prochymal® - High dose
Participants will receive a total dose of Prochymal® 1200 x 10^6 cells, IV infusion, on four days, once daily.
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Drug: Prochymal®
Prochymal® IV infusion
Other Name: Adult Human Mesenchymal Stem Cells |
- Disease remission (CDAI at or below 150) [ Time Frame: 28 days ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00482092

Study Director: | Mahboob Rahman, MD | Mesoblast, Inc. |
Responsible Party: | Mesoblast, Inc. |
ClinicalTrials.gov Identifier: | NCT00482092 |
Obsolete Identifiers: | NCT00609232 |
Other Study ID Numbers: |
CRD 603 |
First Posted: | June 4, 2007 Key Record Dates |
Last Update Posted: | January 13, 2022 |
Last Verified: | January 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Crohn's disease adult stem cell therapy |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Intestinal Diseases Remestemcel-l Anti-Inflammatory Agents Antiviral Agents Anti-Infective Agents |