A Phase I Study Evaluating Autologous Bone Marrow Derived Mesenchymal Stromal for Crohn's Disease. (EPIC/MSC/IBD)
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
|
Crohn's Disease |
Biological: autologous mesenchymal stromal cell |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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. |
- Number of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Monitoring for adverse events at time of MSC infusion and in 12 months following
- Crohn's disease activity Index (CDAI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]CDAI score before and after intervention will be monitored over 12 months
| Enrollment: | 16 |
| Study Start Date: | July 2012 |
| Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: autologous mesenchymal stromal cells | Biological: autologous mesenchymal stromal cell |
Detailed Description:
EPIC MSC/IBD is made up of autologous marrow-derived mesenchymal stromal cells ex vivo expanded numerically for approximately 14 days using pooled human Platelet Lysate (phPL), harvested on the day of infusion, washed and suspended at a concentration of 4 million cells/ml in Plasmalyte A with 0.5% human serum albumin. This is a phase I dose-escalation, open label, non-randomized, non-placebo controlled, single group assignment study to evaluate the safety and tolerability of a single intravenous infusion of EPIC MSC2011-001. EPIC EPIC MSC/IBD will be infused intravenously and will be administered at one of three dose levels: (Tier 1) 2 million cells/kg patient body weight; (Tier 2) 5 million cells/kg, and (Tier 3) 10 million cells/kg. This Phase I clinical trial will enroll 16-20 subjects with moderate to severe Crohn's. The duration of this study for each patient is 12 weeks. The investigators anticipate that this study will be completed within 2 years of commencement.
Primary objective: To describe and compare the safety and tolerability of a single infusion of fresh autologous bone marrow derived Mesenchymal stromal cells infused to patients with moderate to severe Crohn's disease.
Secondary objective: Efficacy of autologous bone marrow derived Mesenchymal stromal cells infusion to patients with moderate to severe Crohn's disease as assessed through disease activity index, and quality of life index.
Safety variables:Adverse events (AEs),Laboratory parameters (hematology, biochemistry, urinalysis), Vital signs.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01659762
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| Principal Investigator: | Subra Kugathasan, MD | Emory University |
| Principal Investigator: | Tanvi Dhere, MD | Emory University |
More Information
Additional Information:
Publications:
| Responsible Party: | Jacques Galipeau, MD, Professor, Emory University |
| ClinicalTrials.gov Identifier: | NCT01659762 History of Changes |
| Other Study ID Numbers: | IRB00051454 EPIC001 |
| Study First Received: | August 6, 2012 |
| Last Updated: | August 2, 2016 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Emory University:
|
inflammatory bowel disease Crohn's disease |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on September 28, 2016