Crohn's Disease
Conditions
Keywords
Crohn's Disease, Stem cell, Cell therapy, Auto-immune disease, furestem, CD, inflammatory bowel disease, MSCs, Mesenchymal Stem Cells, hUCB-MSC, UCB-MSC, Umbilical cord Blood
Brief summary
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 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.
Interventions
BIOLOGICALStem cells
Sponsors
Kang Stem Biotech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. of either gender, aged≥19 and ≤70 years 2. subjects who is diagnosed with Crohn's disease after considering all the factors below. 1. histological or pathological Diagnostic opinion 2. colonoscopic Diagnostic opinion 3. radiologic and hematological Diagnostic opinion 3. subjects who is included in two criteria below and come under CDAI 220-450 during screening period. 1. CRP\>0.3mg/dL during screening period 2. more than 3 nonanastomotic ulcers which is included in Crohn's disease as a result of colonoscopy on screening period(each diameter of ulcers needs to exceed 0.5cm) 4. range of Crohn's disease : an affection of ileum, an affection of large intestine, an affection of ileum and large intestine at once. 5. subjects who suffer from extensive colitis during more than 8 years or limited colitis during more than 12 years need to have evidence that there are no large intestine ulcers by surveillance colonoscopy on screening visit. 6. subjects who are included in two criteria about drug treatment of Crohn's disease like below. 1. subjects who fail the existing treatment and come under more than 1 criterion as below. * subjects who continuously administer Corticosteroid or immunosuppressant (AZA, Methotrexate, 6-MP) * subjects who have history of improper response or intolerance about Corticosteroid or immunosuppressant (AZA, Methotrexate, 6-MP) * subjects who are dependent Corticosteroid or have history of Corticosteroid dependence. 2. subjects who have history of improper response or intolerance about anti-TNF treatment as below. * Infliximab * Adalimumab * Certolizumab pegol 7. subjects who satisfy those clinical examination value below during screening period. * Hemoglobin ≥ 8.0g/dL * WBC ≥ 3,000/μL * Lymphocyte ≥ 500/μL * 100,000/μL ≤ Platelet ≤ 1,200,000/μL * AST and ALT ≤ 3 x the upper limit of normal * ALP ≤ 3 x the upper limit of normal * Serum creatinine ≤ the upper limit of normal * Serum albumin ≥ 2.0g/dL * PT ≤ the upper limit of normal * aPTT ≤ the upper limit of normal 8. subjects who agree with those use of contraceptive method during clinical trial period. 1. woman : subjects who is applicable to more than 1 case below. * subjects who is postmenopausal for more than 1 years before screening visit. * surgically sterility. * If subjects are biological clock, subjects need to agree with prohibition on having sex with man or usage of more than 2 effective contraception from sign of informed consent form until end of the clinical study. 2. man : even surgically sterility(for example, getting a vasectomy), in case of satisfy those conditions below. * subjects who agree with prohibition on having sex with woman or usage of effective barrier contraception from sign of informed consent form until end of the clinical study. 9. subjects who understand and voluntarily sign an informed consent form.
Exclusion criteria
1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events, Ratio of patients who is applicable to CDAI<150 | 4 weeks follow-up after treatment, 12 weeks follow-up after treatment | on phase 1, Phase 2a |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| a variation of CRP value as contrasted with baseline | 12 weeks follow-up after treatment | on phase 2a |
| a variation of MR enterographic score as contrasted with baseline | 12 weeks follow-up after treatment | on phase 2a |
| a variation of fecal calprotectin as contrasted with baseline | 12 weeks follow-up after treatment | on phase 2a |
| the ratio of patients who reduce CDAI over 70 as contrasted with baseline value | 12 weeks follow-up after treatment | on phase 2a |
| a variation of SF-36 score as contrasted with baseline | 12 weeks follow-up after treatment | on phase 2a |
| reduction of the number of draining fistula | 12 weeks follow-up after treatment | on phase 2a |
| all kinds of adverse effects which occur during the clinical study | 12 weeks follow-up after treatment | on phase 2a |
| a variation of IBDQ score as contrasted with baseline | 12 weeks follow-up after treatment | on phase 2a |
Countries
South Korea
Contacts
Primary ContactEun-ji Kang
Outcome results
None listed