Crohn's Disease Clinical Trial
Official title:
An Open-labelled, Multi Center, Comparative Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease
The purpose of phase I clinical trial is to evaluate safety and efficacy in subjects with
moderately active Crohn's disease after injection for 28days.
The purpose of phase IIa clinical trial is to determine therapeutic safety and efficacy of
FURESTEM-CD Inj. which is based on Crohn's disease activity index(CDAI)<150 after injection.
Crohn's disease is mysterious chronic inflammatory bowel disease. It usually happen in the
young age and last forever. It is not yet clearly known the origin of crohn's disease.
However, crohn's disease therapy is getting developed by using immunosuppressant and
TNF-alpha inhibitor. Nonetheless, some patients still don't react to TNF-alpha inhibitor
which is most effective treatment. Also, Even though some other patients reacted to the
treatment at first, the effect of treatment decreases over time. Plus, long-term use of
TNF-alpha inhibitor can lead to complication of infection and occurrence of malignant tumor
like lymphoma. Recently, treatment of intractable crohn's disease is attempted by using stem
cell. Especially, Mesenchymal stem cell is well-known for immunosuppression,
anti-inflammatory ability and cell differentiation ability to various lineage cell as non
hematopoietic stromal cell.
When the body get infected by the pathogens, innate immune response operate as the primary
defence mechanism. at this time, there are some receptors reacting first such as
TLR(toll-like receptor) and NLR(nucleotide-binding oligomerization domain) which is located
in the cytoplasm of a cell. It is reported that the activities of TLR which is expressed by
Mesenchymal stem cells play an important roles about immunomodulatory ability of Mesenchymal
stem cells. Furthermore, human Umbilical Cord Blood derived-Universal Stem Cells( hUCB-USCs)
manifest TLR and NLR of Mesenchymal Stem cells at the same time. when those receptors become
activation, it maximize ability of immunomodulatory. Therefore, hUCB-USCs can be utilized to
cure intractable autoimmune disease like Crohn's disease. Further, It has huge possibility as
cell therapy products for autoimmune disease.
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