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A study to understand intractable immune diseases using 'mini-organs' derived from iPS cells

Elucidation of the mechanisms of intractable immune-mediated diseases using iPS cell-derived organoid models

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1050250064
Enrollment
60
Registered
2025-07-09
Start date
2025-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIH DIHS iDILI Healthy Control Autoimmune hepatitis, Drug-induced hypersensitivity syndrome, Idiosyncratic drug-induced liver injury, Organoid

Interventions

None listed

Sponsors

Takebe Takanori
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients diagnosed with either Autoimmune Hepatitis (AIH), Drug-induced Hypersensitivity Syndrome (DIHS), or Idiosyncratic Drug-induced Liver Injury (iDILI). Healthy subjects appropriate as controls for this study. Individuals who have provided written informed consent to participate in this study.

Exclusion criteria

Exclusion criteria: Individuals deemed unsuitable for this study by the principal investigator or co-investigator for medical or other reasons.

Design outcomes

Primary

MeasureTime frame
(AIH) Identification of candidate self-antigen peptides presented in an HLA-DR4-dependent manner. (AIH) Identification of autoreactive T-cell clones (TCR sequences) that respond to HLO co-culture in an HLA-DR4-dependent manner. (DIHS/iDILI) Identification of potential HLA haplotypes and associated TCR repertoires involved in drug-specific responses using an organoid model/screening system.

Secondary

MeasureTime frame
(AIH) Degree of HLA-DR4-dependent cytotoxicity and cytokine production profiles. (DIHS/iDILI) Degree of drug-dependent cytotoxicity, cytokine production profiles, and T-cell proliferation responses. Correlation analysis of TCR repertoires identified in the iPS model and those in actual patient samples. Validation of T-cell responses to identified candidate self-antigen peptides.

Contacts

Public ContactMasashi Okamoto

Graduate School of Medicine, The University of Osaka

m.okamoto@imed3.med.osaka-u.ac.jp+81-6-6879-3860

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026