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Clinical Trials in South Korea / NCT03183661
Recruiting Observational

A Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in ALLO-ASC-CD-101 Clinical Trial

NCT03183661 · tracked via the Priya Life Science South Korea tracker
Sponsor
Anterogen Co., Ltd
Phase
Observational
Started
2016-11-16
Last updated
2023-08-25

Condition(s) studied

Crohn Disease

Investigational drug(s) / intervention(s)

ALLO-ASC-CD

ALLO-ASC-CD: ALLO-ASC-CD is intravenous infusion containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells are directed to injured tissue, and reduce inflammation. Furthermore their immunomodulatory effects are significant for treating immune-related disease. Finally, ALLO-ASC-CD may provide a new option in treating a crohn's disease. This study is a follow-up study without intervention.

Study summary

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-CD injection in phase 1 clinical trial (ALLO-ASC-CD-101) for 36 months.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Subjects who are injected with ALLO-ASC-CD in phase 1 clinical trial of ALLO-ASC-CD-101. 2. Subjects who are able to give written informed consent prior to study start and to comply with the study requirements. Exclusion Criteria: 1\. Subjects who are considered not suitable for the study by the principal investigator.

Primary outcome measure(s)

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability — up to 36 months
    Evaluation of AE

Trial sites (2)

FacilityCityRegionStatus
Seoul National University Hospital Seoul South Korea Recruiting
Severance Hospital Seoul South Korea Completed

More Anterogen Co., Ltd. trials in South Korea

Clinical Study to Evaluate Efficacy and Safety of ASC and Fibringlue or Fibringlue in Patients With Crohn's Fistula Active, not recruiting
Clinical Study to Evaluate Efficacy and Safety of ANT-301 in Patients With Knee Osteoarthritis in Grade III/IV by K/L Active, not recruiting
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-302 Clinical Trial Recruiting

Other trials for the same condition

A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease Recruiting
TDM-based Infliximab Treatment for Active Perianal Fistulizing Crohn's Disease Recruiting
Predictors of Prognosis in IBD Patients Recruiting
A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease Active, not recruiting
A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03183661 on ClinicalTrials.gov ↗ ← All trials in South Korea