Evaluation of PROCHYMAL[tm] Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease
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Purpose
Osiris 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 at least one biologic agent. The protocol investigates the safety and efficacy of using PROCHYMAL[tm] 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Crohn's Disease |
Drug: adult human mesenchymal stem cells Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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[tm] (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 |
- Disease remission (CDAI at or below 150) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Disease improvement (Reduction by at least 100 points in CDAI) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Improvement in quality of life (IBDQ) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Reduction in number of draining fistulas [ Time Frame: 28 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 270 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Placebo
|
Drug: Placebo
Placebo
|
|
Active Comparator: 2
Low dose (600 million cells total over four infusions in two weeks)
|
Drug: adult human mesenchymal stem cells
Intravenous infusion of suspension of adult human mesenchymal stem cells, total of 1200 million (high dose) or 600 million (low dose) cells infused in four visits over two weeks.
|
|
Active Comparator: 3
High dose (1200 million cells delivered in four infusions over two weeks)
|
Drug: adult human mesenchymal stem cells
Intravenous infusion of suspension of adult human mesenchymal stem cells, total of 1200 million (high dose) or 600 million (low dose) cells infused in four visits over two weeks.
|
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[tm] 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.
Osiris 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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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
- 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 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 TB (unless risk of activation or re-activation deemed low)
Contacts and Locations| Contact: Linda Custer, PhD | 443 545 1807 | lcuster@osiris.com |
Show 65 Study Locations| Study Director: | Linda Custer, PhD | Osiris Therapeutics |
More Information
No publications provided
| Responsible Party: | Osiris Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00482092 History of Changes |
| Obsolete Identifiers: | NCT00609232 |
| Other Study ID Numbers: | Osiris 603 |
| Study First Received: | May 30, 2007 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by Osiris Therapeutics:
|
Crohn's disease adult stem cell therapy |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013