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ActiCells™ GMP hiPSCs (CD34<sup>+</sup> Cord Blood Cells, Normal, Male)

ActiCells™ GMP hiPSCs (CD34+ Cord Blood Cells, Normal, Male)

SKU ASE-9280 Categories , , ,

ActiCells™ GMP hiPSCs

CD34+ Cord Blood Cells, Normal, Male

Confidently develop tomorrow’s cell-based therapies with GMP-compliant hiPSCs manufactured in our California facilities. The hiPSCs are:

  • Regulatory-ready—covered by a U.S. FDA DMF to streamline IND and other regulatory filings 
  • Isogenic with RUO version—seamless RUO-to-GMP transition to accelerate development timelines 
  • U.S.-manufactured under cGMP—ensures high-quality, traceable, and consistent production 
  • Comprehensive GMP services—genome editing, differentiation, and cell banking all available in GMP-compliant environment
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Overview

ActiCells™ GMP hiPSCs (Cat. # AST-9280) are clinical-grade human induced pluripotent stem cells manufactured in the United States under cGMP conditions and covered by a U.S. FDA Drug Master File (DMF) to facilitate regulatory submissions. Reprogrammed from CD34+ cord blood cells using a transgene-free episomal method, these well-characterized iPSCs are an ideal starting point for therapeutic development and custom manufacturing.

Isogenic with our RUO research line, ActiCells™ GMP-Matching RUO hiPSCs (Cat. # ASE-9250), ActiCells™ GMP hiPSCs enable a smooth progression from research optimization to GMP-compliant production. With deep expertise in iPSC genome editing, Applied StemCell can engineer custom knock-ins, knock-outs, and other complex modifications in your GMP-grade cells—and support you with downstream differentiation and cell banking to match your clinical program needs.

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Each vial of ActiCells™ GMP hiPSCs contains 1 x 106 cells. Full characterization details are available upon request.
Table Header Table Header
Reprogramming method
Episomal
Donor tissue
CD34+ Umbilical Cord Blood Cells
Gender
Male
Clinical information
Normal
Quantity
1 x 106 cells/vial

Supporting data

The following data is from the ActiCells™ GMP-Matching RUO hiPSCs (Cat. # ASE-9250). Full characterization data for the ActiCells™ GMP hiPSC line is available upon request. 

ActiCells™ GMP-Matching RUO hiPSCs maintain pluripotent stem cell morphology after thawing

Figure 1. ActiCells™ GMP-Matching RUO hiPSCs maintain pluripotent stem cell morphology 24 hours (left) and 72 hours (right) after thawing.

ActiCells™ GMP-Matching RUO hiPSCs are pluripotent

Figure 2. ActiCells™ GMP-Matching RUO hiPSCs show strong, uniform expression of pluripotency markers Oct4, Sox2, Nanog, SSEA-4, and TRA-1-60 (top row) with DAPI staining (blue) on the bottom row.

Figure 3. ActiCells™ GMP-Matching RUO hiPSCs differentiate into the three germ layers, demonstrating excellent differentiation potential. (A) Endoderm is demonstrated by alpha-fetoprotein (AFP) immunofluorescence (IF, green), (B) ectoderm by Neuron-specific class III β-tubulin (Tuj1) IF, and (C) mesoderm by smooth muscle actin (SMA) IF. DAPI staining in blue.

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Frequently asked questions

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Yes. ActiCells™ GMP hiPSCs are manufactured under cGMP and can be genome edited, differentiated, and cell banked as additional services all under GMP compliance.

Each vial contains 1 x 106 cells, shipped on dry ice. Upon receipt, store in a liquid nitrogen freezer. For optimal results, use within six months of receipt.

Yes, a certificate of analysis (CofA) is available upon request, providing full details on viability, sterility, short tandem repeat profiling (STR), and mycoplasma testing.

We provide detailed protocols for thawing, feeder-free culturing, and cryopreservation, ensuring ease of use for your research team.

ActiCells™ GMP hiPSCs are derived from CD34+ umbilical cord blood cells using episomal reprogramming.

Episomal reprogramming is a non-integrative method, meaning it does not alter the genome, reducing the risk of genetic mutations.

Yes, ActiCells™ GMP hiPSCs are validated for key pluripotency markers (Oct4, Sox2, Nanog, SSEA-4, TRA-1-60) and undergo rigorous quality control for genetic purity and viability.

ActiCells™ GMP hiPSCs can differentiate into all three germ layers (endoderm, mesoderm, ectoderm), making them suitable for diverse research applications.

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