Evaluating the safety of a new stem cell treatment for Crohn's disease

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

This study is testing a new stem cell treatment for Crohn's disease to see if it is safe for people who haven't found relief with regular medications.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Anterogen Co., Ltd. (industry)
• Locations: 1 site (Seoul)
• Trial ID: NCT02580617 on ClinicalTrials.gov

What this trial studies

This phase I study aims to assess the safety of ALLO-ASC-CD, an intravenous infusion of allogenic adipose-derived mesenchymal stem cells, for treating Crohn's disease. The treatment targets injured tissue and aims to reduce inflammation, leveraging the immunomodulatory properties of stem cells. Participants will be monitored for safety and tolerability as they receive this novel therapy. The study focuses on patients who have not responded to conventional treatments for Crohn's disease.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a diagnosis of Crohn's disease who have shown intolerance or failure of conventional therapies.

Not a fit: Patients who are not diagnosed with Crohn's disease or those who have not failed conventional treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with Crohn's disease who have not benefited from existing therapies.

How similar studies have performed: Other studies using stem cell therapies for Crohn's disease have shown promise, but this specific approach is relatively novel.

Eligibility 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

Where this trial is running

Seoul

• Yonsei University College of Medicine — Seoul, Korea, Republic of (RECRUITING)

Study contacts

• Principal investigator: Won Ho Kim — Yonsei University
• Study coordinator: Won Ho Kim, MD., PhD

Conditions: Crohn's Disease