A clinical-grade HLA haplobank of human induced pluripotent stem cells matching approximately 40% of the Japanese population.
Level 5 - mechanism / opinion, no new human data
Preclinical laboratory resource development and cell line characterization without direct clinical patient trial outcome data
PubMed 36395757 · doi:10.1016/j.medj.2022.10.003
What was done
Researchers established a clinical-grade human induced pluripotent stem cell (iPSC) haplobank under Good Manufacturing Practice (GMP) regulations. Donors with homozygous human leukocyte antigens (HLAs) were recruited, and peripheral or umbilical cord blood was reprogrammed into iPSCs via episomal vector electroporation. The resulting cell lines underwent safety and quality testing, including sterility assessments and genomic analyses for mutations and residual vector presence.
What was found
The bank generated 27 clinical-grade iPSC lines derived from 7 HLA-homozygous donors, covering approximately 40% of the Japanese population for immunological matching. Safety screening identified that reasons to avoid using certain lines included the presence of residual episomal vectors or mutations in cancer-related genes. The generated cell lines have been used in more than 10 clinical trials since 2015.
Why it matters
This resource provides an off-the-shelf, standardized bank of clinical-grade iPSCs, reducing immunological rejection barriers and manufacturing timelines for allogeneic cell therapies.
Limits
The haplobank is specifically tailored to HLA allele distributions in the Japanese population and offers limited applicability elsewhere. The entire resource relies on 7 donors, and the abstract does not report exact numerical pass/fail rates for genomic alterations or residual vector clearance.
Cited by
- supports Shinya Yamanaka and colleagues have established an induced pluripotent stem cell (iPSC) bank of HLA-compatible cell lines designed to support allogeneic cell transplantation across diverse human populations.