Key Dates

Related Announcements

• May 13, 2014 - NINDS Requirements for Induced Pluripotent Stem Cell Development and Resource Sharing. See Notice NOT-NS-14-032.

Issued by

National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The purpose of this Notice is to update the research community to the current NINDS guidelines for development and distribution of human induced pluripotent stem cells (iPSCs) through the NINDS Human Cell and Data Repository (NHCDR).

All iPSC lines available through NHCDR have a Certificate of Assurance which provides quality control data (sterility, cell recovery, karyotype, identity match (if applicable), surface antigen expression of stem cell markers and pluripotency analysis), as well as information on the method of derivation, passage method, passage number and split ratio for each line. The NHCDR catalog?is updated frequently, and investigators are encouraged to visit the website on a regular basis to access the availability of new human fibroblast and iPSC lines.

Based on the availability of these resources, NINDS will not support the deposition and banking of iPSC lines (e.g. control lines and/or lines with specific mutations) that are already represented in the NINDS Repository. Gene editing to develop isogenic lines for mutant iPSC in the repository, where non exists, is encouraged (see below).  

Investigators who propose to develop and use iPSC lines not represented in the NHCDR, for hypothesis-driven research, and anticipate depositing these lines in NHCDR, are strongly encouraged to consult the NHCDR Program Manager prior to submission of a grant application proposing development or use of iPSC lines. Applicants interested in banking with NHCDR should request a quote to include in the application prior to submission. NHCDR can also facilitate the intake of original/distinct, established cell lines. Investigators interested in adding established iPSC lines to NHCDR should contact NHCDR for more information.

Quality Control and Freedom to Operate Requirements for iPSC lines to be banked with the NINDS Repository

In addition to requiring compliance with standard NIH resource sharing policies, NINDS may request that novel investigator-developed iPSC lines and source cells be made available through NHCDR. Such a request for deposition of iPSC lines will be made prior to the release of a notice of grant award and will further be specified in the notice of grant award. 

• Patient consent accompanying the source cell material must allow for broad sharing of the cell lines and associated de-identified data (with academic and industry investigators) including for use in genetic studies, wherein part or all of the genome may be sequenced.
• When IP is applicable, the institution/facility must have all necessary legal authority for sharing, and document this authority, including any necessary licenses for iPSC and related (e.g. genome editing, reporter use) technologies that allow deposition and broad distribution of resulting iPSC lines through NHCDR.
• All iPSC lines derived under NINDS funding mechanisms and deposited with NHCDR must be characterized for sterility and be free of mycoplasma contamination, have normal karyotypes, normal growth rates and colony morphology, demonstrated pluripotency through a pluritest, scorecard test or equivalent test, demonstrate surface antigen expression of stem cell markers, demonstrated ability to form embryoid bodies and demonstrated transgene silencing for the reprogramming factors used; 
• A timeline must be provided in the application for banking of source material and availability of the iPSC lines with the NINDS Repository. 

Investigators are strongly encouraged to contact the NHCDR Program Manager prior to application submission and provide explanation of the broad applicability of the iPSC lines to be developed in the application.

Development of isogenic iPSC Lines
For generation of isogenic lines, that are to be deposited in the NINDS Repository, and where the disease causing mutation is represented in NINDS Repository iPSC lines, investigators are encouraged to perform gene editing in the available NINDS Repository iPSC lines. Furthermore, such grant applications should budget for and propose whole genome sequencing of the parent, where applicable, and edited clones. The genetic data generated along with available de-identified clinical data will be deposited in an appropriate NIH data repository such as NIH database of Genotypes and Phenotypes (dbGaP) in coordination with NINDS Program Staff.

Inquiries

Please direct all inquiries to:

Rebecca Price, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-594-0541
Email: rebecca.price@nih.gov