StemRNA™ Clinical Grade iPSCs
for Your Cell Therapy Application

Why choose our clinical-grade iPSCs for your iPSC-derived cell therapies?

REPROCELL is a trusted partner for cell therapy developers who are seeking robust, high-quality, clinical-grade induced pluripotent stem cell (iPSC) lines that meet industry standards. 

As we have global access to a roster of donors, we can procure the starting material for your cell therapy project,  perform the mandatory viral and donor profile screenings, and ensure that donor samples are fully consented for clinical and commercial use. The informed consent forms contain specific information fundamental to iPSC-related cell therapy products. Our experts use our proprietary footprint-free RNA reprogramming technology and clinical-grade media reagents to generate StemRNA™ Clinical iPSC Seed Clone Lines.  

REPROCELL’s StemRNA™ Clinical Seed iPSCs serve as a reliable foundation for various cell therapy programs by ensuring safety, consistency, and regulatory compliance. These iPSC Seed Clones can be expanded in a GMP environment to manufacture Master Cell Banks (MCB), which can be further downstream processed to generate a final drug product. 

Our clinical-grade iPSCs are currently being evaluated by many biopharma companies globally, have been included in regulatory filings, and are IND approved.

REPROCELL offers GMP MCBs of iPSC, iMSC, and MSC manufactured by our stem cell experts in compliance with the regulatory standards and guidelines of the US FDA, European EMA, and Japanese PMDA. Our regulatory support team will provide all necessary quality and regulatory documents, such as donor eligibility, CoA, batch records, traceability documentation, and quality technical agreement for your cell therapy project filing with the selected agency. 

Every StemRNA Clinical Grade iPSC seed clone, its corresponding donor material, and any subsequent GMP MCB batch are assessed for genetic integrity by performing a combined approach of two complementary techniques:

We conduct low-resolution G-band karyotyping to ensure a normal broad structural state of the chromosomes, including the absence of any numeric aberrations and structural variants. For higher resolution analysis, we perform NGS-based oncogenetic analysis to profile for genetic variants in over 400 cancer-related genes for a deeper molecular insight.

For each ready-to-use clinical iPSC clone, we provide an oncogenetic report that analyses for high-impact genetic variants and interprets them using publicly available clinical databases.

FDA Drug Master File (DMF)—exclusively covering iPSCs manufactured at our U.S. site and accessible via a simple Letter of Authorization (LOA). 

• HLA and KIR (Killer-cell immunoglobulin-like receptors) genotyping data are available for all donors.
• Multiple clones are generally available from each donor.
• Different clonal lines are validated for their differentiation potential into various specific cell types. Depending on the iPSC clone, this includes: HSCs (hematopoietic stem cells), NSCs (neural stem cells), NK (Natural Killer) cells, astrocytes, and iGRPs (induced glia-restricted progenitors) and others. 
• If you have specific donor criteria, we can identify and screen a donor that meets your needs.
• New differentiation data on the various lines are regularly becoming available, which may make it easier to pick the right clonal line to test in your therapeutic project.  

If you want to find out more about our clinical stem cell services, please contact our experts.

News and Advantages of REPROCELL's Clinical RNA iPSCs

REPROCELL is a pioneer in using mRNA for generating iPSCs. mRNA generates high-quality iPSCs that are uniquely suited for clinical applications.  

• mRNA is not retained in cells, eliminating concerns of retention of reprogramming vectors.
• mRNA cannot be integrated into the genome.
• iPSCs reprogrammed with mRNA show lower rates of genomic abnormalities

REPROCELL’s StemRNA™ Clinical iPSC Seed Stock Clones enabled a historic breakthrough in assisted reproduction: Gameto’s Fertilo platform delivered the world’s first live birth involving ovarian support cells entirely manufactured from our clinical-grade iPSCs.

These ovarian support cells closely mirror the natural ovarian environment, allowing in vitro oocyte maturation with minimal hormonal intervention, reducing patient burden and potential complications such as ovarian hyperstimulation syndrome.

An IND officially was approved by the U.S. Food and Drug Administration, allowing launch of the first-ever Phase 3 iPSC-based therapy trial in the United States, marking the first application of human iPSC-derived cells in IVF and redefining what cell-based fertility therapies can achieve.

Want to learn more? Read the full blog post: 

Live imaging of human iNK cells engulfing tumor K562 cells. The elongated human iNK cells demonstrated cytotoxic properties when co-cultured with K562 cells (a human chronic myeloid leukemia cell line), labeled with the cell staining reagent CFSE (green round cells). These results show that iNK cells exhibit mature function in identifying and destroying foreign cells.

Data acquired in collaboration with Tokyo Metropolitan Institute of Medical Science in Japan.