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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Inje University Haeundae Paik Hospital
Busan, South Korea
RECRUITINGYeungnam University Medical Center
Daegu, South Korea
RECRUITINGSeoul National Universtiy Bundang Hospital
Seongnam-si, South Korea
Number of Participants with Adverse Events, Ratio of patients who is applicable to CDAI<150
on phase 1, Phase 2a
Time frame: 4 weeks follow-up after treatment, 12 weeks follow-up after treatment
the ratio of patients who reduce CDAI over 70 as contrasted with baseline value
on phase 2a
Time frame: 12 weeks follow-up after treatment
a variation of CRP value as contrasted with baseline
on phase 2a
Time frame: 12 weeks follow-up after treatment
a variation of MR enterographic score as contrasted with baseline
on phase 2a
Time frame: 12 weeks follow-up after treatment
a variation of fecal calprotectin as contrasted with baseline
on phase 2a
Time frame: 12 weeks follow-up after treatment
a variation of IBDQ score as contrasted with baseline
on phase 2a
Time frame: 12 weeks follow-up after treatment
a variation of SF-36 score as contrasted with baseline
on phase 2a
Time frame: 12 weeks follow-up after treatment
reduction of the number of draining fistula
on phase 2a
Time frame: 12 weeks follow-up after treatment
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Severance Hospital
Seoul, South Korea
RECRUITINGAsan Medical Center
Seoul, South Korea
RECRUITINGSoeul National University Hospital
Soeul, South Korea
RECRUITINGThe Catholic University of Korea, St. Vincent'S Hospital.
Suwon, South Korea
RECRUITINGall kinds of adverse effects which occur during the clinical study
on phase 2a
Time frame: 12 weeks follow-up after treatment