Cell Line Provenance Policy
| Proposed Material | Information, Examples, etc. | Provenance Documents To Be Submitted By Investigators |
|---|---|---|
| Registered Pluripotent Cell Lines | • NIH Registered • CIRM Registered • UK Stem Cell Bank • UK Human Fertilization & Embryology Authority • Canadian National Stem Cell Oversight Committee • Japanese Guidelines for Derivation & Utilization of Human Embryonic Stem Cells | Appropriate registry name and registry number for each line. Some lines may require approval documentation from the registry. |
| Non-Registered Embryonic Pluripotent Cell Lines | Cell lines provided by a company, institution, or collaborator that do not appear on one of the above registration lists | 1. A sample Consent Document 2. IRB (or equivalent) Approval Letter appropriate to the Consent document |
| Induced Pluripotent Cells (iPS) | Source Material: • Fresh Somatic Cells: see guidance below • Archived Somatic Cells: see guidance below | Please provide the appropriate documentation based on the source material. |
| Fresh Somatic Cells for the purpose of generating a) induced or re- programmed pluripotent cells, or b) neural stem cells (NSC) that will be used for in vivo transplantation | Usually in the form of tissue (e.g., punch biopsy, foreskin, residual tissue from surgical procedure, etc.) | 1. A sample Consent Document 2. IRB (or equivalent) Approval Letter (at UCI, hSCRO approval precedes UCI IRB review and approval) 3. In some instances, a statement from the providing company or institution indicating specimens are de-identified, no access to the key code will be granted, and appropriate IRB (or equivalent) oversight was in place at the time of donation is acceptable. |
| Archived Somatic Cells for the purpose of generating a) induced or re- programmed pluripotent cells, or b) NSC that can be used for in vivo transplantation | Usually obtained from a tissue bank | Please provide written acknowledgement from provider (i.e., Tissue bank, Institution, etc.,) indicating specimens are de-identified, and you will not receive access to the key code under any circumstance. |
| Fetal Tissue-derived multipotent stem cells | Usually obtained from a tissue bank or academic institution | Please follow the guidance above for Fresh Somatic Cells |
| Fetal Tissue | Aborted pregnancy materials, pathology samples | Provide the following statements as outlined in Code of California Regulations title 17 § 100085: Use of Fetal Tissue. • Statement signed by woman donating the material (can be in the form of a sample Informed Consent document) • Statement signed by attending physician (can be in the form of a sample Informed Consent document) • Statement signed by Principal Investigator |
| Embryos/Oocytes | 1. Consent Document (either sample IRB- approved Consent or Consent document proposed for use) 2. In both instances (Embryos and Oocytes) IRB Approval is required |