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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Subject is 18 to 65 years of age. 2. Subject who is diagnosed Crohn's disease by endoscopic or radiologic result during more than 6 months. 3. Subject who show intolerance or failure of conventional therapy (steroids, immunosuppressive and TNF-alpha inhibitor) 4. Subject who is included CDAI 220-450 during screening period. 5. CRP>0.5mg/dL during screening period. 6. 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. 7. 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. 8. Negative for urine beta-HCG for women of childbearing age. 9. Subject is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. 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. 2. Subjects who have been received biological therapy within 60 days of enrollment.. 3. 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. 4. Subject who has malignant tumor or which is not cured yet. 5. Subject has any serious disease, in the opinion of the Investigator, would interfere with the evaluation of the study. 6. Subject who has history of blood clots and other pathological arterial thrombosis or venous thrombosis. 7. Subject who has a hypersensitive reaction to bovine-derived proteins. 8. Subject who is surgery or trauma within 6 weeks before registration. 9. Subject who is pregnant or breast-feeding. 10. Subjects who are unwilling to use an "effective" method of contraception during the study. 11. Subject who is experienced stem cell therapy. 12. Subject who has been enrolled in another clinical study within 4weeks days of screening. 13. Subject who has history of alcohol or drug abuse. 14. Subject who is not able to understand the objective of this study or to comply with the study requirements

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02580617
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Anterogen Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Won Ho Kim
Principal Investigator Affiliation Yonsei University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Korea, Republic of
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn's Disease
Additional Details

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.

Arms & Interventions

Arms

Experimental: ALLO-ASC

Group 1: 5.0 x 10^7 cells Group 2: 7.5 x 10^7 cells Group 3: 10.0 x 10^7 cells

Interventions

Biological: - ALLO-ASC

Infusion for Crohn's disease

Contact a Trial Team

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International Sites

Yonsei University College of Medicine, Seoul, Korea, Republic of

Status

Recruiting

Address

Yonsei University College of Medicine

Seoul, ,

Site Contact

Won Ho Kim, MD., Ph D

kimwonho@yuhs.ac

82-2-2228-1951

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