IMMUNOSTEM: PD-L1 gene-modified autologous HSPCs
What this study tests
Altheia first-in-human trial using a person's own CD34+ hematopoietic stem and progenitor cells, genetically modified ex vivo to express PD-L1, for recent-onset T1D with residual beta-cell function.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2025-04-22.
Source dates appear in the references where available; this record has no dated citation metadata.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Adults aged 18–40 within 180 days of T1D diagnosis, with at least two diabetes autoantibodies and stimulated C-peptide of at least 0.2 nmol/L. Additional transplantation, infection and organ-function criteria apply. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- No results posted yet.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: European Union. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Treatment-related adverse events assessed by CTCAE v5.0
The full picture
This record has no longer discussion. Use the study criteria, reported results and original sources on this page to assess what is known and what remains unresolved.
Sources
- [1]NCT06938334: IMMUNOSTEM: PD-L1 gene-modified autologous HSPCs · Trial registry