Resources
Cell Therapy Regulatory Bodies
Cell Therapy Regulatory Reference Materials
- Draft Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products (11/12)
- Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products (1/11)
- Draft Guidance for Industry: Somatic Cell Therapy for Cardiac Disease (10/10)
- Draft Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (1/09)
- ISSCR Guidelines for the Clinical Translation of Stem Cells [pdf] (12/03/08)
- Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs) (4/08)
- Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug applications (INDs) (4/08)
- Draft Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products (2/08)
- Guidance for Industry: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) – Small Entity Compliance Guide (8/07)
- Guidance for Industry: Gene Therapy Clinical Trials-Observing Participants for Delayed Adverse Events (11/06)
- Guidance for Industry: Compliance with 21 CFR Part 1271.150(c)(1) – Manufacturing Arrangements (9/06)
- Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (5/05)
- Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans (4/03)
- Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Contacts (2/02)
- Guidance for Industry: Public Health Issues Posed by the Use of Non-Human Primate Xenografts in Humans (4/99)
- Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy (3/98)
Cell Therapy Related Associations
Cell Therapy Related Publications
- Cell Stem Cell (IF 25.3)
- Stem Cells (IF ~8)
- Stem Cells and Development (IF ~4.7)
- Stem Cell Research (IF ~ 4.5)
- Stem Cell Reviews and Reports (2012 Impact Factor 4.532)
- Regenerative Medicine (IF ~3.9)
- Cellular Reprogramming (used to be called Cloning and Stem Cells) IF is 2.744
- Stem Cell Reports
- Stem Cells Translational Medicine
- Cell Regeneration
- Journal of Stem Cells….and not to be outdone…..
- Journal of Stem Cells & Regenerative Medicine
- Stem Cells International…not to be confused with…
- International Journal of Stem Cells
- World Journal of Stem Cells
- The Open Stem Cell Journal
- Stem Cells and Cloning ….and not to be outdone…..
- Stem Cells and Cloning: Advances and Applications
- Stem Cell Research & Therapy…..not to be confused with….
- Current Stem Cell Research & Therapy
- Stem Cell Discovery
- Stem Cell Biology and Research
- American Journal of Stem Cell Research
- Hematology/Oncology and Stem Cell Therapy