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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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24 October 2016 |
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Main ID: |
NCT01659762 |
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Date of registration:
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06/08/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Phase I Study Evaluating Autologous Bone Marrow Derived Mesenchymal Stromal for Crohn's Disease.
EPIC/MSC/IBD |
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Scientific title:
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A Phase I Study Evaluating Safety and Tolerability of Autologous Bone Marrow Derived Mesenchymal Stromal (MSC) Cells in Adults With Moderate to Severe Crohn's Disease. |
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Date of first enrolment:
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July 2012 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01659762 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Subra Kugathasan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Emory University |
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Name:
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Tanvi Dhere, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Emory University |
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Key inclusion & exclusion criteria
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Inclusion Criteria
- Men and women 18-65 years of age.
- Patient must have had CD for at least 3 months from the time of initial diagnosis.
The diagnosis of CD must have been confirmed by endoscopic and histological evidence.
- Patients must have active Crohn's disease as defined by a Crohns Disease Activity
Index (CDAI) score between >220 at screening and baseline.
- Patients should have no need for immediate surgery (i.e. due to obstruction,
strictures, active abscess or perforations ).
- Subjects must be refractory (defined as lack of response for at least 3 months) to
immunomodulators (including 6-mercaptopurine and azathioprine and methotrexate) or
anti-TNF therapy at present or some point in the course of their disease. Lack of
response is defined by failure to reduce the CDAI score by at least 70 points.
- The following medications will be allowed: mesalamine and prednisone (stable dose for
at least 2 weeks prior to enrollment).
- Subjects on anti TNF therapy will require a minimum of 4 weeks washout period prior
to screening.
- Subjects on non-steroidal analgesics require a minimum of 2 weeks washout period
prior to screening
- If female and of child-bearing age, patient must be non-pregnant, non-breastfeeding,
and use adequate contraception;
- Patient is willing to participate in the study and has signed the informed consent.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Biological: autologous mesenchymal stromal cell
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Primary Outcome(s)
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Number of adverse events
[Time Frame: 12 months]
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Secondary Outcome(s)
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Crohn's disease activity Index (CDAI)
[Time Frame: 12 months]
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Secondary ID(s)
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IRB00051454
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EPIC001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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