StemEdit Gene Edited Research iPSCs

Off-the-shelf hypoimmune cell lines

REPROCELL has developed high-quality HLA knockout iPSC lines using StemEdit—our state-of-the-art genome editing technology, which takes advantage of an AI-enhanced nuclease system. It is also well-suited for clinical gene-editing projects.

Benefits of StemEdit human iPSCs

By using our cell lines, you can immediately start your research using HLA knockout iPSCs without the hassle of editing iPSC lines yourself. In both cell lines, either one or both alleles (homozygous) of the target genes (B2M, CIITA) are knocked out, and this reliably suppresses HLA expression.

The introduction of the new hypoimmune StemEdit Human iPSC lines marks a significant milestone in advancing immune research and regenerative medicine. By enabling researchers to study and manipulate immune cell interactions with unprecedented precision, these cell lines exemplify REPROCELL's commitment to empowering scientific discovery. We will continue to innovate and provide world-class tools to support breakthroughs in cell therapy and immunology.

— Dr. Chikafumi Yokoyama, CEO of REPROCELL Inc.

The Science of StemEdit human iPSCs

StemEdit human iPSCs grown in vitro stain positive for standard pluripotency markers

StemEdit Human iPSC non-HLA class 1 (B2M Homo KO) and non-HLA class 1/2 (B2M/CIITA Homo double KO) cells were cultured using NutriStem hPSC XF Medium (01-0005) on iMatrix-511 (NP892-011). Pluripotency for both cell lines was confirmed by the strong expression of Nanog, Oct3/4, and SSEA4, as well as negative for the negative marker SSEA-1.

Below:  B2M/CIITA Homo double KO cells.

StemEdit™ human iPSCs exhibit the expected karyotype

Karyotyping of StemEdit Human iPSC non-HLA class 1/2 (B2M/CIITA Homo double KO)(RCRP052) was performed, and the strain displayed a normal karyotype (46, XX).

Confirmation of HLA class 1 expression suppression

HLA class 1 expression levels in both the double knockout strain and the parent strain (LLF-34-F3) were evaluated by flow cytometry analysis using an anti-HLA-ABC antibody. HLA class I expression was confirmed in the parent strain, and HLA class I expression was significantly suppressed in B2M/CIITA double KO (RCRP052), where the B2M gene was knocked out.

StemEdit™ Human Hypoimmune iPSCs

High-quality parent line: Clinical-grade iPSC line LLF-34-F3

Pioneering iPSC-based Therapies with Clinical-Grade iPSCs

The StemRNA Clinical-grade iPSC line LLF-34-F3, established by REPROCELL, is used as the parent line for the preparation of the StemEdit HLA knockout iPSC lines. Our clinical-grade iPSCs have the following features.

• Regulatory compliance: Developed and manufactured in a process complying with the FDA (United States), EMA (Europe), and PMDA (Japan) regulatory requirements.
• Rigorous Donor Screening: Healthy donors who have undergone appropriate screening following regulatory guidelineswith ethical considerations.
• Manufacturing at a GMP-compliant facility: Manufactured and frozen under strict quality control following SOP (Standard Operating Procedures) at a GMP facility.
• High safety: The reprogramming method for iPSC generation employs mRNA, eliminating the risk of genomic insertion, minimizing transgene residuals, and ensuring exceptional safety standards.

Our clinical-grade iPSCs are at the forefront of regenerative medicine, empowering companies and research institutes globally to develop innovative therapies.

A prime example is Gameto's Fertilo technology, which leverages REPROCELL' StemRNA™ Clinical Seed iPSC Clones to create high-purity ovarian support cells for ex vivo egg maturation (Cell Stem Cell, 33, 1-15 (2026)). Fertilo has achieved a significant milestone as the first iPSC-based therapy to receive IND approval and advance to U.S. Phase 3 clinical trials.

Related Products

The items below are all available from the REPROCELL product catalog:

Sartorius® NutriStem™ hPSC XF
Culture Medium

Matrixome® iMatrix™-511
Stem Cell Culture Substrate