A Study to Evaluate the Safety of ALLO-ASC-CD for Treatment of 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 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.

Study Overview

• Status: Recruiting
• Conditions: Crohn's Disease
• Intervention / Treatment: Biological: ALLO-ASC

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 9
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Won Ho Kim, MD., PhD; Phone Number: 82-2-2228-1951; Email: kimwonho@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Yonsei University College of Medicine
    • Contact: Won Ho Kim, MD., Ph D; Phone Number: 82-2-2228-1951; Email: kimwonho@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Biological: ALLO-ASC; Infusion for Crohn's disease; Other Names: ALLO-ASC-CD

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Anterogen Co., Ltd.
• Investigators: Principal Investigator: Won Ho Kim, Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2015
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: October 15, 2015
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (Estimated): October 20, 2015

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: ALLO-ASC-CD-101