Last updated on February 2018

Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD)

Brief description of study

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.

Detailed Study Description

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.

Clinical Study Identifier: NCT02000362

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Tae-oh Kim

Inje University Haeundae Paik Hospital
Busan, Korea, Republic of
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Byung-Ik Jang

Yeungnam University Medical Center
Daegu, Korea, Republic of
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Hyuk Yoon

Seoul National Universtiy Bundang Hospital
Seongnam-si, Korea, Republic of
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Jae-hee Cheon

Severance Hospital
Seoul, Korea, Republic of
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Suk-kyun Yang

Asan Medical Center
Seoul, Korea, Republic of
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Jong-pil Im

Soeul National University Hospital
Soeul, Korea, Republic of
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Kang-moon Lee

The Catholic University of Korea, St. Vincent`S Hospital.
Suwon-si, Korea, Republic of
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