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

  • STATUS
    Recruiting
  • End date
    Jun 2, 2023
  • participants needed
    9
  • sponsor
    Anterogen Co., Ltd.
Updated on 26 January 2022
immunosuppressive agents
tumor necrosis factor
conventional treatment
crohn's disease
tumor necrosis factor alpha
ulceration

Summary

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.

Description

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.

Details
Condition Crohn's Disease
Treatment ALLO-ASC
Clinical Study IdentifierNCT02580617
SponsorAnterogen Co., Ltd.
Last Modified on26 January 2022

Eligibility

Yes No Not Sure

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
Hemoglobin 8.0g/dL B. WBC 3,000/L C. Lymphocyte 500/L D.100,000/L Platelet 1,200,000/L 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
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
In case that the PI anticipates that patients need to get a surgical intestinal tract surgery caused by crohn's disease
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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