Certain disorders are challenging to study in vitro due to an inaccessibility of donor tissue, e.g., neurodegenerative and psychiatric disorders of the brain and spinal cord and cardiomyopathies of the heart. Similar to embryonic stem cells, iPSCs have the capacity for unlimited self-renewal and the ability to differentiate into cell types from the three embryonic germ layers: ectoderm, mesoderm, and endoderm. Thus, human iPSCs make it possible to generate an unlimited capacity of previously inaccessible cell types, such as neurons and cardiomyocytes, while capturing the genetic diversity of patients with specific mutations or disease. iPSCs can be used to study the molecular mechanisms of disease, have the potential to be utilized for cell and gene therapies, and can be used in the drug discovery process for the evaluation of toxic compounds.

Start your research confidently with human iPSCs from STEMCELL that are ethically sourced, donor-consented, and Institutional Review Board (IRB)-approved for academic and commercial research. iPSC products purchased from STEMCELL are manufactured using stringent quality control parameters that either meet or exceed industry standards and are detailed in the lot-specific Certificate of Analysis (CoA). Additional transparency is provided by registration of iPSC lines in hPSCreg®—a global human pluripotent stem cell (hPSC) registry that improves visibility, confidence in ethical provenance, validation of characterization data, and comparability with other registered lines.

Use STEMCELL’s iPSC lines to establish a complete workflow for your cell culture system. Optimized for long-term maintenance and expansion in TeSR™ media, and validated for differentiation to a multitude of lineage-specific cell types and organoids using STEMdiff™ media systems, our iPSC lines provide flexibility for a wide range of research applications.

STEMCELL uses a proprietary non-integrating reprogramming technology to reprogram donor-consented peripheral blood mononuclear cells (PBMCs) for the development of zero-footprint iPSC lines. A number of early iPSC clones are selected, banked for safekeeping, expanded in culture using mTeSR™ Plus and ReLeSR™, and analyzed for genomic integrity and pluripotency. Reprogramming vector clearance is confirmed for the highest-performing clone(s), which then enter the Master Cell Banking process after passage 20 and undergo extensive quality control procedures. Working cell banks and commercial vials derived from working cell banks undergo a subset of characterization analyses. iPSCs are banked and cryopreserved for long-term storage in CryoStor® CS10 at -196°C (-320°F).

STEMCELL recognizes that a lack of well-defined guidelines for naming human pluripotent stem cell (hPSC) lines has led to confusion and duplication of cell line names and identities in the research field. As a result, we use the standardized nomenclature established by hPSCreg® that (1) unambiguously identifies a registered cell line, (2) allows tracing of subclones, and (3) enables the assignment of different cell lines to a particular donor:

Example: SCTi003-A

Explanation: STEMCELL Technologies iPSC Donor 3 Clone A

Extensive quality control procedures are implemented at every stage of STEMCELL’s iPSC manufacturing process. Master cell banks are tested for identity, adventitious agents, genomic integrity and stability, survival, undifferentiated state, and pluripotency. For detailed information on the specific quality control tests performed on master cell banks, please refer to the Quality Control section of this FAQ.

Working cell banks and commercial vials are tested for a subset of these characterization criteria. For more information on the quality control (QC) of a particular iPSC line, please refer to the lot-specific Certificate of Analysis (CoA). For more information about STEMCELL’s commercial iPSC release criteria, see the Quality Control section of this FAQ.

In some cases, additional clones may be available for an iPSC line. However, alternate clones will not have been characterized to the same extent as the commercial iPSC line and may only be available at an early passage number. To inquire about alternate clones for an iPSC line, please contact us.

Yes, customers are required to agree to the standard license agreement for iPSCs and pay an annual license fee for the use of STEMCELL’s iPSC lines. The annual license fee is priced at $5,000 USD per iPSC line and is capped at $20,000 USD per year (i.e. use of more than four iPSC lines will not incur higher annual license fees). Customers working for non-profit organizations (e.g. universities) may be eligible for a fee waiver. To inquire about the standard license agreement, annual license fees, or to discuss your eligibility for an annual license fee waiver, please contact us. Refer to the Licensing and Usage section of this FAQ for more information.

STEMCELL is able to support your iPSC experiments with a suite of products designed to help you get the results you need. Attend one of our training programs to learn the latest iPSC techniques and protocols and perform your experiments with confidence. Our scientists and educators offer comprehensive virtual or hands-on technical training programs that are customizable for your specific needs.

Learn more about STEMCELL's training programs >

STEMCELL collects donor demographic information ethically, using consent forms and protocols approved by either an Institutional Review Board (IRB), the Food and Drug Administration (FDA), the U.S. Department of Health and Human Services, and/or an equivalent regulatory authority. Donations are performed in the United States in compliance with applicable federal, state, and local laws, regulations, and guidance.

Our Quality Assurance, Quality Control, and Regulatory Affairs departments are ready to assist you with any necessary documentation to meet specific institutional requirements, including supplier approval for ease of procurement.

Contact us for further information on the collection of donor demographics.

The following donor attributes are determined for each iPSC donor and are provided with each iPSC line. Full donor details are listed on the Product Information Sheet (PIS) and further in-depth analyses (including ClinVar and ancestry reports) are included in the Certificate of Analysis (CoA).

If additional donor attributes (not included in the table above) are required for your experiments, please contact us, and a representative will be in touch to work with you on your desired order.

Healthy donors must be over the age of 18, weigh at least 120 lb, have a body mass index (BMI) between 18.5 - 24.9, demonstrate no use of tobacco products, and be in good general health.

Donors in our “healthy” pool are pre-screened using a health questionnaire aimed at excluding any donors with diseases, blood disorders, or other health concerns. Donors are tested for infectious diseases (HIV-1, HIV-2, hepatitis B, and hepatitis C), and other diseases or conditions are self-reported. An intake questionnaire containing questions about the donor’s health history and current condition is completed on the day of collection. Donors are restricted from donating if they are feeling unwell or have a fever. Additional blood parameter assessments are performed, including white blood cell counts, platelet levels, hematocrit, and blood pressure; any values outside of the acceptable normal range or minimum level would eliminate the sample from the healthy pool. Health questionnaires and donor inclusion/exclusion criteria are overseen by a medical director at each collection site.

Participants are not eligible for this program if they present with any of the following characteristics:

• High blood pressure
• Blood-borne or sexually transmitted disease(s) (hepatitis B or C, HIV-1 or HIV-2, syphilis)
• Diabetes (Type 1 or 2)
• Thyroid issues
• Heart, lung, kidney, or liver problems
• Currently pregnant or nursing

If specific health information is required or if your research project has any restrictions, please contact us to see if we can source an iPSC donor for you as a special request. Note: This may require donor recruitment or screening at an additional cost.

Ancestry refers to the geographic origins of a person’s ancestors. For example, European, African, South Asian, or East Asian. Ancestry is a donor attribute that is genetically calculated.

Race refers to physical differences that groups and cultures consider socially significant. For example, people might identify their race as Aboriginal, African American or Black, Asian, European American or White, Native American, Native Hawaiian or Pacific Islander, Māori, or another race. Race is an attribute that is self-declared by STEMCELL’s iPSC donors.

Ethnicity refers to shared cultural characteristics such as language, ancestry, practices, and beliefs. For example, people might identify as Hispanic, Latino, or another ethnicity. Ethnicity is an attribute that is self-declared by STEMCELL’s iPSC donors.

Analysis of the coding regions of the human genome for germline and somatic mutations by whole exome sequencing (WES) is becoming commonplace in translational cancer genomics studies and in the field of precision medicine. Identifying a donor’s ancestry is essential for interpreting the impact of personal genetic variation on experimental results.

Whole exome sequencing (WES) data is processed using EthSEQ, an analytical pipeline for identifying conserved ancestral groups. EthSEQ inspects WES data from each iPSC line, focusing on the differential single nucleotide polymorphism (SNP) genotype profile. This profile contains variants known to be particularly informative of ancestral heritage. Each donor profile is compared to a reference database containing thousands of genotypes of known ancestries collated from the 1000 Genomes Project. Subsequent principal component analysis (PCA) identifies donor ancestry by comparison to the reference database and calculates a percentage for each ancestry. STEMCELL’s internal ancestry determination workflow has been validated using WES data from the Simons Genome Diversity Project, a database that contains genotype data from hundreds of individuals with known ancestries, thus generating more comprehensive ancestral predictions.

Whole exome sequencing (WES) datasets are sequenced at a depth of 50x, indicating that each nucleotide of the exome (the collection of all coding sequences) is sequenced 50 times. From this redundant coverage, a highly accurate consensus sequence is derived, allowing for the identification of genomic single nucleotide polymorphisms (SNPs; representing genetic variants). The resulting profile of genetic variants is compared against ClinVar, a public archive of reports that detail relationships between human genetic variants and phenotypes, and any resulting pathogenic or likely pathogenic variants are determined. ClinVar analysis includes germline and somatic variants of any size, type, or genomic location.

Yes, WES and WGS data files are available to customers of the corresponding iPSC line(s) for a fee. Please note that you must be purchasing or have previously purchased the iPSC line that you wish to acquire the WES and/or WGS data files for. Customers are required to acknowledge that no attempt will be made to identify the donor using sequencing data.

STEMCELL is an advocate for standardizing human pluripotent stem cell data reporting and quality control measures to limit experimental variability and ensure that relevant, reproducible findings are shared. Our commercial iPSC quality assessments and release criteria have been developed based on recommendations and guidance from the International Stem Cell Banking Initiative (ISCBI) (2009), the Global Alliance for iPSC Therapy (GAiT) (2018), and consensus workshops hosted in 2022 by the International Society for Stem Cell Research (ISSCR) and International Stem Cell Initiative (ISCI).

Assessment	Manufacturing Stage
	Pre-Master	Master Cell Bank	Working Cell Bank	Commercial Cell Bank
Viability	-	✓	✓	✓
Recovery	-	✓	✓	✓
Sterility	-	✓	✓	✓
Viral screen	-	✓	-	-
Mycoplasma	-	✓	✓	✓
Cell line identity	-	✓	✓	✓
Residual vector	✓	-	-	-
T cell clonality assay*	✓	-	-	-
Karyotype	✓	✓	✓	✓
20q FISH	-	✓	-	-
Copy number variants	-	✓	✓	✓
Whole exome sequencing	-	✓	-	-
Undifferentiated marker analysis	-	Yes, 5 passages after thaw	Yes, 3 passages after thaw	Yes, 3 passages after thaw
Trilineage differentiation	✓	✓	-	-

Copy number variants (CNVs) determined by SNP microarray analysis are reported in the lot-specific Certificate of Analysis (CoA) for each iPSC line.

The SNP microarray can detect aneuploidy, deletions, and duplications of represented loci, and regions of loss/absence of heterozygosity (LOH), but cannot detect balanced alterations (reciprocal translocations, Robertsonian translocations, inversions, and insertions), or point mutations.

Reportable copy number changes are gains or losses greater than 400 kb (highlighted in bold in the Copy Number Variant Report). Reportable regions of LOH are greater than 5 Mb. See Interpretation for copy number changes and regions of LOH that meet these criteria. See Call Table for all copy number changes identified by the analysis software. If mosaicism is detected, the approximate percentage of mosaicism is listed in the ‘Variant Type (% mosaic)’ column.

QC results are included in the lot-specific Certificate of Analysis (CoA), which can be retrieved or requested online. To retrieve a CoA, a catalog number and lot number are required. This information can be found on the product label or invoice and should be entered exactly as shown, including all numbers, letters, and dashes. In some cases, a CoA may not be available online. If your search does not retrieve a CoA, please complete the form in the Request Certificate tab. One of our representatives will contact you to provide the relevant information.

An example CoA for the SCTi003-A cell line can be found here.

The Terms and Conditions of Sale can be found here.

STEMCELL provides iPSCs to researchers under the following Limited-Use License:

These iPSCs shall be used for customers’ internal research. These iPSCs and their modifications (including but not limited to derivatives or differentiated progeny) shall not be used or administered in (1) human subjects for human clinical use; (2) animals for veterinary use for therapeutic, diagnostic or prophylactic purposes; or (3) any subject in relation to, without limiting the generality of the foregoing, clinical applications, cell therapy, transplantation, and/or regenerative medicines.

Customers need a license to cover commercial uses of these iPSCs and/or their modifications (including but not limited to derivatives or differentiated progeny), including but not limited to the following: (a) for the manufacture of any product; (b) for screening compounds, antibodies, proteins, or peptides for commercial use, except for target discovery, target validation or assay development; (c) sale, lease, distribution, transfer or the use of such cells to provide a service, information or data to a third party; (d) use by a for-profit organization for its internal research and not for financial gain. All requests for a commercial license for these iPSCs should be directed to iPSCrequests@stemcell.com. Other than the rights granted herein, no other right, express or implied, is conveyed by the sale of these iPSCs.

PRODUCTS ARE FOR RESEARCH USE ONLY AND NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES UNLESS OTHERWISE STATED.

STEMCELL’s standard license agreement for iPSCs can be found here.

Example Applications of iPSCs or Progeny	Permitted / Not Permitted	Notes
Academic research by a non-profit entity such as a university	Permitted
Educational purposes by a non-profit entity such as a university	Permitted
Internal research by a commercial entity	Permitted
Provide service(s), information, or data to a third party for no financial gain	Permitted
Transfer to a third party to perform service(s) on behalf of the customer, such as genome editing, QC, differentiation, or drug development assays	Permitted	After the service has been completed, any resulting cell product(s) may not be resold.
Screening compounds, antibodies, proteins, or peptides for commercial use	Partially permitted	Screening with the intent to discover a marketable compound is not permitted under STEMCELL’s standard license agreement and requires an additional license from iPS Academia Japan, Inc. Target discovery, target validation, disease modeling, and assay development are permitted.
Distribution or transfer to a third party for no financial gain	Partially permitted	An iPSC line from STEMCELL may be distributed or transferred free-of-charge to end users that (1) are members of the same institute and (2) work in the same physical location and/or site as the original laboratory that purchased the line.
Direct administration to (1) human subjects for human clinical use or (2) animals for veterinary use for therapeutic, diagnostic or prophylactic purposes, including clinical applications, cell therapy, transplantation, and regenerative medicines	Not permitted
Development of regulatory registered human diagnostic products (e.g. in vitro diagnostics)	Not permitted
Manufacture of related products for sale (e.g. cell culture medium or instruments)	Not permitted	Requires an additional license from iPS Academia Japan, Inc.
Sale, lease, distribution, transfer, or license for financial gain	Not permitted	Additional approval required. Please contact us for further information.
Provide service(s), information, or data to third parties for financial gain	Not permitted	Additional approval required. Please contact us for further information.