A Study to Evaluate the Safety of ALLO-ASC-CD for Treatment of Crohn's Disease

Study Overview
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Brief Summary
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This is a phase I study to evaluate the safety of ALLO-ASC-CD for the treatment of crohn' disease. ALLO-ASC-CD is intravenous infusion containing allogenic adipose-derived mesenchymal stem cells.

Detailed Description
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Adipose-derived stem cells are directed to injured tissue, and reduce inflammation. Furthermore, their immunomodulatory effects are significant for treating immune-related diseases, such as crohn's disease. Finally, ALLO-ASC-CD may provide a new option in treating a crohn's disease.

Official Title
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A Phase 1 Clinical Study to Evaluate the Safety of Allogeneic Adipose-derived Stem Cells in the Subjects With Crohn's Disease

Conditions
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Crohn's Disease

Intervention / Treatment
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* Biological: ALLO-ASC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 18 to 65 years of age Subject who is diagnosed Crohn's disease by endoscopic or radiologic result during more than 6 months Subject who show intolerance or failure of conventional therapy (steroids, immunosuppressive and TNF-alpha inhibitor) Subject who is included CDAI 220-450 during screening period CRP>0.5mg/dL during screening period Subject who show affected sites by crohn's disease in either ileum and large intestine or both of them, including more than 1 nonanastomotic ulcers as a result of colonoscopy. Subjects who satisfy those clinical examination value below during screening period. A. Hemoglobin ≥ 8.0g/dL B. WBC ≥ 3,000/μL C. Lymphocyte ≥ 500/μL D.100,000/μL ≤ Platelet ≤ 1,200,000/μL E. AST and ALT ≤ 3 x the upper limit of normal F. ALP ≤ 3 x the upper limit of normal G.Serum creatinine ≤ the upper limit of normal H.Serum albumin ≥ 2.0g/dL I.PT , aPTT≤ the upper limit of normal Negative for urine beta-HCG for women of childbearing age. Subject is able to give written informed consent prior to study start and to comply with the study requirements. Exclusion Criteria: Subject with gastro-intestinal tract A. Crohn's disease which is invaded only proximal ileum. B. The evidence of an intra abdominal abscess during screening period. C. The evidence of an abscess around the anus during screening period. D. Conditions of subtotal colectomy or total colectomy. E. Short bowel syndrome. F. Subject who conduct elemental diet, tube feeding or parenteral nutrition within 3 weeks before enrollment. G. Subject who have ileostomy or colostomy. H Subject who have a bowel stricture of large intestine that may be significant by PI's decision during screening period. I. In case that the PI anticipates that patients need to get a surgical intestinal tract surgery caused by crohn's disease. J. Subject who have adenoma of large intestine K. Subject who have chronic inflammation-associated dysplasia. Subjects who have been received biological therapy within 60 days of enrollment.. Subject with infectious disease A. Acute or chronic active HBV, HAV and HIV B. Active tuberculosis. C. IGRA (Interferon-Gamma Release Assay) positive D. All kinds of live vaccine inoculation except influenza vaccine within 4weeks before registration E. Pneumonia, pyelonephritis and Infection of Clostridium within 4weeks during screening visit. F.Subject has history of bacteremia or other serious bacterial or fungal infection in past 3 months. Subject who has malignant tumor or which is not cured yet Subject has any serious disease, in the opinion of the Investigator, would interfere with the evaluation of the study. Subject who has history of blood clots and other pathological arterial thrombosis or venous thrombosis Subject who has a hypersensitive reaction to bovine-derived proteins Subject who is surgery or trauma within 6 weeks before registration Subject who is pregnant or breast-feeding. Subjects who are unwilling to use an effective method of contraception during the study Subject who is experienced stem cell therapy Subject who has been enrolled in another clinical study within 4weeks days of screening Subject who has history of alcohol or drug abuse. Subject who is not able to understand the objective of this study or to comply with the study requirements

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALLO-ASC<br>Group 1: 5.0 x 10^7 cells Group 2: 7.5 x 10^7 cells Group 3: 10.0 x 10^7 cells | Biological: ALLO-ASC<br>* Infusion for Crohn's disease<br>* Other names: ALLO-ASC-CD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Clinically measured abnormality of laboratory tests and adverse events) | Clinically measured abnormality of laboratory tests and adverse events | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CDAI value | Change in the CDAI value | up to 4 weeks | 
| The ratio of patients applicable to CDAI <150 | The ratio of patients applicable to CDAI <150 | Week 4 |