A Phase I Study Evaluating Autologous Bone Marrow Derived Mesenchymal Stromal for Crohn's Disease. (EPIC/MSC/IBD)
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|ClinicalTrials.gov Identifier: NCT01659762|
Recruitment Status : Completed
First Posted : August 8, 2012
Last Update Posted : October 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Biological: autologous mesenchymal stromal cell||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||July 2015|
|Experimental: autologous mesenchymal stromal cells||
Biological: autologous mesenchymal stromal cell
- Number of adverse events [ Time Frame: 12 months ]Monitoring for adverse events at time of MSC infusion and in 12 months following
- Crohn's disease activity Index (CDAI) [ Time Frame: 12 months ]CDAI score before and after intervention will be monitored over 12 months
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): NCT01659762
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Subra Kugathasan, MD||Emory University|
|Principal Investigator:||Tanvi Dhere, MD||Emory University|