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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, utilizing a proprietary nuclease system. is also well-suited for clinical gene-editing projects.

We offer the following two products to meet the research needs of our customers:

StemEdit™ Human iPSC non-HLA class 1/2 (B2M/CIITA Homo double KO)

B2M Knockout iPSC Line:
StemEdit™ Human iPSC non-HLA class 1
(B2M Homo KO)
suppresses HLA class 1 expression

B2M CIITA KO line

StemEdit™ Human iPSC non-HLA class 1
(B2M Homo KO)
(cat. no. RCRP044E)

B2M/CIITA Double Knockout iPSC Line:
StemEdit™ Human iPSC non-HLA class 1/2
(B2M/CIITA Homo double KO)
suppresses both HLA class 1 and HLA class 2 expression

B2M CIITA KO line

StemEdit™ Human iPSC non-HLA class 1/2
(B2M/CIITA Homo double KO)
(cat. no. RCRP043E)

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.

✓
High-quality genome editing: Powered by our proprietary, highly efficient StemEdit technology, distinct from CRISPR/Cas9.
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Homozygous knockout: Mutations are introduced into both alleles of the target gene to ensure reliably suppressed expression.
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License: No additional license is required for basic research purposes, including animal testing. If you are considering commercial use and/or clinical applications of edited iPSC lines, REPROCELL can provide a license to you for the use of the StemEdit genome editing technology. Please contact us for further details.
✓
Clinical-grade derivation: REPROCELL's StemRNA high-quality clinical-grade iPSC lines are used as the parent strains.

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.

Below: (A.) stained B2M Homo KO cells; (B.) B2M/CIITA Homo double KO cells.

A

B2M KO pluripotency markers expression

B

B2M CIITA KO pluripotency markers expression

StemEdit™human iPSCs exhibit the expected karyotype

Karyotyping of StemEdit Human iPSC non-HLA class 1/2 (B2M/CIITA Homo double KO)(RCRP043E) and StemEdit Human iPSC non-HLA class 1 (B2M Homo KO)" (RCRP044E) was performed, and both strains were found to have normal karyotypes (46, XX).

StemEdit Kariotyoing report

Confirmation of HLA class 1 expression suppression

HLA class 1 expression levels in both strains and the parent strain (VCT-37-F35) 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 Homo double KO (RCRP043E) and B2M Homo KO (RCRP044E), where the B2M gene was knocked out.


StemEdit™ Human Hypoimmune iPSCs 

Cat. No. Strain ID Donor Race Donor Sex Donor Age Donor Clinical Status

Reprogramming 
Method

 Gene Editing Technology Tissue Source
RCRP044E StemRNA™ Clinical iPSC Clone VCT-37-F35 Caucasian Female 23 Healthy StemRNA™ Clinical
Technology

 

 StemEdit™
(proprietary nuclease system)

 

 Fibroblasts

 
RCRP043E StemRNA™ Clinical iPSC Clone VCT-37-F35 Caucasian Female 23 Healthy StemRNA™ Clinical
Technology

StemEdit™
(proprietary nuclease system)

 Fibroblasts

 

High-quality parent line: Clinical-grade iPSC line VCT-37-F35

Pioneering iPSC-based Therapies with Clinical-Grade iPSCs

The StemRNA Clinical-grade iPSC line VCT-37-F35, 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 guidelines with ethical considerations.
  • Manufacturing at a GMP-compliant facility: Manufactured and frozen under strict quality control following SOP (Standard Operating Procedures) at a PMDA (MHLW) approved GMP facility that has obtained a license to manufacture specific cell products.
  • 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 our StemRNA™ Clinical Seed iPSC Clones to create high-purity ovarian support cells for ex vivo egg maturation. 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:

Want to use iPSCs in a clinical context?

GMP iPSC & iMSC MCB Manufacturing Service

REPROCELL’s scientists manufacture GMP iPSC & iMSC Master Cell Banks (MCBs) that are compliant with the regulatory standards and guidelines of the FDA, EMA, and PMDA.

Discover our clinical stem cell services

GMP iPSC/iMSC MCB Manufacturing – REPROCELL USA

GMP iPSC/MSC MCB Manufacturing – Histocell (Europe Partner Overview)

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