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Clinical Stem Cell Services

REPROCELL's StemRNA™ Clinical iPSCs:
Clinical starting material for cell therapy programs & GMP manufacturing

REPROCELL supports cell therapy developers at every stage of iPSC development

  • StemRNA™ Clinical iPSC Seed Clones
  • StemRNA™ Clinical iPSC Pilot Clones for research evaluation and process development
  • Custom iPSC generation tailored to your project
  • GMP master cell bank (MCB) manufacturing for downstream clinical application

Clinical iPSC Production Workflow at Seed Clone Stage

Updated Clinical Workflow figure

Why choose REPROCELL for your clinical iPSC program?

REPROCELL provides an integrated clinical iPSC workflow supporting cell therapy development from early evaluation to GMP manufacturing. The process starts with fibroblast isolated from screened, clinically consented donors, then reprogrammed using our proprietary footprint-free StemRNA™ Clinical RNA Reprogramming Technology. HLA and KIR (Killer-cell immunoglobulin-like receptors) genotyping data are available for every donor. Multiple iPSC clones are generated and characterized to produce GMP-compatible seed clones for clinical programs and corresponding research-use pilot clones. This approach enables efficient clone selection and a seamless transition into downstream applications such as StemEdit Gene Editing or GMP Master Cell Bank (MCB) production providing a consistent, regulatory-aligned starting point for clinical cell therapy manufacturing.

Key Advantages

  • Flexible entry points: Custom iPSC generation, Seed clones, or direct GMP MCB manufacturing

  • Global donor access: USA-based collections with IRB-approved informed consent and full regulator screening. Donor eligibility screening follows FDA 21 CFR 1271, EMA Directive 2006/17/EC, and PMDA Notification No. 375 guidelines.

  • Footprint-free RNA reprogramming: Proprietary RNA technology for reliable iPSC generation

  • Smooth research-to-clinic transition for faster program progression

  • Regulatory-aligned processes: Consistent, traceable, and compliant with FDA, EMA, and PMDA

  • Regulatory support: Designed to facilitate regulatory filings and IND-approved programs

Choose the right starting point for your iPSC program

1. Exclusive StemRNA Clinical Seed Clones

Tailored iPSC generation from clinically consented donors, aligned with your therapeutic strategy and regulatory requirements. You can provide the clinical fibroblasts, or we can collect, screen, and isolate the fibroblasts for you.

2. Our bank of StemRNA Clinical Seed Clones

Tap into our bank of pre-generated clinical clones. Many StemRNA Clinical iPSC Seed Clones also have a corresponding RUO version (StemRNA Clinical iPSC Pilot Clones) for research evaluation.

3. GMP MCB Manufacturing Service

Submit your clinical clone for GMP-compliant MCB manufacturing. Clones are expanded and banked under GMP conditions creating well-characterized, traceable starting material for downstream development and ensuring consistent, regulatory-ready quality.

What is the difference between
ready-to-use Seed and Pilot Clones?

Vial with label clinical iPSC page

StemRNA Clinical iPSC Seed Clones (Clinical-use)

StemRNA™ Clinical iPSC Seed Clones are designed as the clinical starting material for cell therapy development. Produced under GMP principles and with comprehensive quality control (QC), they enable the generation of GMP Master and Working Cell Banks (MCB/WCB) for regulated downstream manufacturing.

  • Manufactured at REPROCELL USA or REPROCELL Japan GMP facility
  • Compliant with US FDA, European EMA, and Japanese PMDA regulations
  • Ready for GMP MCB and working cell bank (WCB) manufacturing
  • Included in regulatory filings, INTERACT meetings and IND submissions
  • Active FDA Drug Master File (DMF) for all U.S.-manufactured clones
  • Advanced into US FDA Phase 3 clinical trial
  • OncoPanel genetic integrity report for every seed clone and fibroblast line
  • Straightforward commercial & licensing structure
  • Different clonal lines have been validated for their differentiation potential into various specific cell types, as proof of principle. This includes: HSCs (hematopoietic stem cells), NSCs (neural stem cells), NK (Natural Killer) cells, astrocytes, iGRPs (induced glia-restricted progenitors), iMSC (iPSC-derived Mesenchymal Stem Cells), and others.

  • New differentiation data are regularly added, making it easier to select the best clonal line for your therapeutic project.

2-2

StemRNA Clinical iPSC Pilot Clones (Research-use)

These are research-grade pilot clones derived from our clinical seed clone platform. Intended for evaluation and process development only, they provide a cost-effective way to test, optimize and validate workflows before moving to a clinical seed clone.

Both the Seed Clones and the Pilot Clones include an evaluation period to determine their suitability for your process. During the evaluation period, sufficient vials of the Seed Clones will be reserved for you to carry forth into GMP iPSC Master Cell Bank generation after successful evaluation.

Available StemRNA Pilot & Seed Clones 

Donor

Gender

Age

Race

Clinical Status

Blood Type

Donor A

Female

25

Asian
(subcontinental India)

Healthy

B+

Donor B *

Female

23

Caucasian

Healthy

A+

Donor C

Female

22

Caucasian

Healthy

O+

Donor D

Male

23

Caucasian

Healthy

A+

Donor E

Male

27

Caucasian

Healthy

A+

Donor F

Male

60

Caucasian

Healthy

O−

* Find out more information in the technical summary: StemRNA™ Clinical Seed Clone Used in Fertilo Development (US Phase 3)

Explore our comprehensive quality control and characterization testing data of our iPSC lines. 

News & Regulatory Feedback 

One of REPROCELL’s StemRNA™ Clinical iPSC Seed Clones (from Donor B, Female 23 yo, Caucasian, Healthy A+) enabled a historic breakthrough in assisted reproduction: Gameto’s Fertilo platform achieved the world’s first live birth using ovarian support cells fully derived 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 was offcially 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 human iPSC-derived cell application in IVF, redefining cell-based fertility therapy possibilities.

Read the press release: Gameto Announces FDA IND Clearance for Fertilo using REPROCELL’s StemRNA™ Clinical Seed iPSCs.

Gameto Baby
Case Study

From Clinical iPSC Seed Clone to
U.S. Phase 3 Cell Therapy

Regulatory Support & Documentation

FDA Drug Master File (DMF)—exclusively covering iPSCs manufactured at our U.S. site and accessible via a simple Letter of Authorization (LOA). All necessary quality and regulatory documents, such as donor eligibility, CoA, batch records, traceability documentation, quality technical agreement will be provided for your cell therapy project filing with the selected agency.

Commercial License Available

All our tissue donors have been fully consented for clinical and commercial use of their cells.

We can also provide the necessary clinical and commercial licenses for your project – making us a hassle-free one-stop solution provider for your iPSC needs. 

Fibroblasts microscopy cells stained-1

Explore Relevant Pages:

Contact our experts

At REPROCELL, our scientists understand that your custom iPSC project must be as unique as your research. If you have any questions about how our Clinical iPSC Generation Service can help you advance your project, please make an inquiry using the form below.