Information on Stem Cell Research

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David Owens, Ph.D.
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do47h@nih.gov

Phone: (301) 496-1447

Human Pluripotent Stem Cell (hPSC) Research Using Non-Embryonic Sources (R01) [Summary]
Application Receipt Date:
Announcement Number: PA-08-043
Funding Contact: David Owens, Ph.D. Program Area: Repair and Plasticity

Human Pluripotent Stem Cell (hPSC) Research Using Non-Embryonic Sources (R21) [Summary]
Application Receipt Date:
Announcement Number: PA-08-044
Funding Contact: David Owens, Ph.D. Program Area: Repair and Plasticity

Interactions Between Stem and Progenitor Cells and the Microenvironment In Vivo (R01) [Summary]
Release Date: April 21, 2005
Announcement Number: PAS-05-092
Funding Contact: David Owens, Ph.D. Program Area: Repair and Plasticity

The NIH Stem Cell Information web page lists many useful NIH websites for investigators interested in stem cell research. http://stemcells.nih.gov
NIH has established the NIH Stem Cell Task Force to enable and accelerate the pace of stem cell research and to seek the advice of scientific leaders in stem cell research. http://stemcells.nih.gov/policy/taskforce/
NIH Human Embryonic Stem Cell Registry currently lists all cell lines that meet the eligibility criteria for Federally funded research that are currently available for shipping. http://escr.nih.gov
Criteria for Federal Funding of Stem Cell Research and the Establishment of NIH Human Embryonic Stem Cell Registry. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html
National Institutes of Health guidelines for research using human pluripotent stem cells (Effective August 25, 2000, 65 FR 51976) (Corrected November 21, 2000, 65 FR 69951; and partially withdrawn November 7, 2001, NOT-OD-02-007). http://stemcells.nih.gov/policy/guidelines.asp, and http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-007.html
Federal Government Clearances for Receipt of International Shipment of Human Embryonic Stem Cells. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-013.html
The National Institutes of Health and WiCell Research Institute, Inc., Stem Cell Research Agreement http://www.nih.gov/news/pr/sep2001/od-05.htm

Center for Biologics Evaluation and Research (CBER) http://www.fda.gov/cber/
CBER Guidances / Guidelines / Points to Consider - a comprehensive listing of documents that provides information detailing CBER's regulatory approach for a various categories of biological products. http://www.fda.gov/cber/guidelines.htm
FDA/CBER Tissue Action Plan - details CBER's strategy for the regulation of cellular and tissue-based products. http://www.fda.gov/cber/tiss.htm
Cellular therapies developed from human embryonic stem cell lines initially maintained by culturing on murine feeder cell layers are considered xenotransplantation products - FDA/CBER Xenotransplantation Action Plan details a comprehensive regulatory approach for xenotransplantation regulation. http://www.fda.gov/cber/xap/xap.htm
Submitting an Investigational New Drug (IND) Application to FDA/CBER http://www.fda.gov/cber/ind/ind.htm

Last updated January 12, 2009