Materials Submitted to NIH From Reproductive Genetics Institute (RGI) Submissions #2009-ACD-006 & 2009-ACD-007 (Both submissions have the same supporting documentation) I. Submission Cover Page (2009-ACD-006) p.l II. Submission Cover Page (2009-ACD-007) p. 11 III. Letter from RGI President p. 19 IV. Description of Supporting Information p. 20 V. Investigational Review Board Approval p. 25 VI. Research Consent p. 26 VII. Assurance Documents p. 31 VIII. Publications p. 38 IX. IIB Assurance p. 56 X. Additional Information: • Other Details via Email Correspondence p. 58 • IVF Clinical Consent (Couple A) p. 60 • Cryopreservation Consent (Couple A) p. 64 • Research Consent with Dates for Couple A; p. 69 (Document text is identical to Item VI, p. 26) • IVF Clinical Consent (Couple B) p. 74 • Research Consent with Dates for Couple B; p. 78 (Document text is identical to Item VI, p. 26) • Other Details via Email Correspondence p. 83 • Other Details via Email Correspondence p. 86 NOTE: Duplicative information in the submission is not included. Table of Clinical IVF and Research Consent Dates not included to protect patient privacy. List Page -hESC Registry Application Database Page 1 of 10 hESC Registry Application Database Detailed Listing for Request #: 2009-ACD-006 April 21, 2010 hESC Registry Application Search Results Request #: 2009-ACD-006 Organization: Reproductive Genetics Institute Status: Pending Org Address: 2825 North Halsted St., Chicago, IL 60657 USA DUNS: 790373369 Grant Number(s): n/a Review: ACD Signing Official (SO): Verlinsky Oleg / 773-472-4900 / [email protected] Submitter of Request: Strelchenko Nick / 773-472-4900 / Assurance: Yes (Section [email protected]:[email protected] Certification: Yes Submitter Comments: (None) Authority: Line #1: RG-148; DYSTROPHIA MYOTONICA 1 (DM1), affected, 46,XY Cell Lines: 24 NIH Approval #: Available: 24 Available: Yes Embryo from U.S.: Yes Previous #: Embryo Donated in Year(s): 2003 2009-DRAFT-022 Provider Name: Reproductive Genetics Institute Provider Phone: 773-472-4900 Email Provider Email: [email protected] Edit Provider URL: http://www.reproductivegenetics.com/ Delete Provider Restrictions: cell line limited for research purposes by Material Switch to ADM Transfer Agreement and cannot be used for experiment nuclear transfer and chimera production NIH Restrictions: Additional Information: Line #2: RG-153; DYSTROPHIA MYOTONICA 1 (DM1), affected, 46,XX NIH Approval #: Available: Yes Embryo from U.S.: Yes Embryo Donated in Year(s): 2003 Provider Name: Reproductive Genetics Institute Provider Phone: 773-472-4900 Provider. Email: [email protected] Provider URL: http://www.reproductivegenetics.com/ Provider Restrictions: cell line limited for research purposes by Material Transfer Agreement and cannot be used for experiment nuclear transfer and chimera production NIH Restrictions: i Additional Information: Line #3: RG-170; MUSCULAR DYSTROPHY, BECKER TYPE (BMD), affected, 46,XY NIH Approval #: Available: Yes Embryo from U.S.: Yes Embryo Donated in Year(s): 2004 http://hescregapp.od.nih.gov/login/list.htni?DetailList=yes&id=22 4/21/2010 List Page-hESC Registry Application Database Page 2 of 10 Provider Name: Reproductive Genetics Institute Provider Phone: 773-472-4900 Provider Email: [email protected] Provider URL: http://www.reproductivegenetics.com/ Provider Restrictions: cell line limited for research purposes by Material Transfer Agreement and cannot be used for experiment nuclear transfer and chimera production NIH Restrictions: Additional Information: Line #4: RG-186; HUNTINGTON DISEASE (HD), affected, 46,XX NIH Approval #: Available: Yes Embryo from U.S.: Yes Embryo Donated in Year(s): 2004 Provider Name: Reproductive Genetics Institute Provider Phone: 773-472-4900 ext.2158 Provider Email: [email protected] Provider URL: http://www.reproductivegenetics.com/ Provider Restrictions: cell line limited for research purposes by Material Transfer Agreement and cannot be used for experiment nuclear transfer and chimera production NIH Restrictions: Additional Information: Line #5: RG-194; HUNTINGTON DISEASE (HD), affected, 46,XY NIH Approval #: Available: Yes Embryo from U.S.: Yes Embryo Donated in Year(s): 2004 Provider Name: Reproductive Genetics Institute Provider Phone: 773-472-4900 ext.2158 Provider Email: [email protected] Provider URL: http://www.reproductivegenetics.com/ Provider Restrictions: cell line limited for research purposes by Material Transfer Agreement and cannot be used for experiment nuclear transfer and chimera production NIH Restrictions: Additional Information: Line #6: RG-233; HEMOGLOBIN BETA LOCUS (HBB), affected (HbS/HbS - sickle cell anemia), 46,XX NIH Approval #: Available: Yes Embryo from U.S.: Yes Embryo Donated in Year(s): 2005 Provider Name: Reproductive Genetics Institute Provider Phone: 773-472-4900 ext.2158 http://hescregapp.od.nih.gov/login/list.htm? 4/21/2010 List Page - hESC Registry Application Database Page 3 of 10 3 Provider Email: [email protected] Provider URL: http://www.reproductiveqenetics.com/ Provider Restrictions: cell line limited for research purposes by Material Transfer Agreement and cannot be used for experiment nuclear transfer and chimera production NIH Restrictions: Additional Information: Line #7: RG-245; EMERY-DREIFUSS MUSCULAR DYSTROPHY, X- LINKED (EDMD), carrier, 47,XXY NIH Approval #: Available: Yes Embryo from U.S.: Yes Embryo Donated in Year(s): 2005 Provider Name: Reproductive Genetics Institute Provider Phone: 773-472-4900 ext.2158 Provider-Email: [email protected] Provider URL: http://www.reproductivegenetics.com/ Provider Restrictions: cell line limited for research purposes by Material Transfer Agreement and cannot be used for experiment nuclear transfer and chimera production NIH Restrictions: Additional Information: Line #8: RG-246; EMERY-DREIFUSS MUSCULAR DYSTROPHY, X- LINKED (EDMD), affected, 46,XY NIH Approval #: Available: Yes Embryo from U.S.: Yes Embryo Donated in Year(s): 2005 Provider Name: Reproductive Genetics Institute Provider Phone: 773-472-4900 ext.2158 Provider Email: [email protected] Provider URL: http://www.reproductivegenetics.com/ Provider Restrictions: cell line limited for research purposes by Material Transfer Agreement and cannot be used for experiment nuclear transfer and chimera production NIH Restrictions: Additional Information: Line #9: RG-271; TORSION DYSTONIA 1 ( DYT1), AUTOSOMAL DOMINANT, affected (N/GAG del), 46,XY NIH Approval #: Available: Yes Embryo from U.S.: Yes Embryo Donated in Year(s): 2006 Provider Name: Reproductive Genetics Institute Provider Phone: 773-472-4900 ext.2158 http://hescregapp.od.nih.gov/login/list.htm?DetailList==yes&id=22 4/21/2010 List Page - hESC Registry Application Database Page 4 of 10 4 Provider Email: [email protected] Provider URL: http://www:reproductivegenetics.com/ Provider Restrictions: cell line limited for research purposes by Material Transfer-Agreement and cannot be used for experiment nuclear transfer and chimera production NIH Restrictions: Additional Information: Line #10: RG-283; MUSCULAR DYSTROPHY, DUCHENNE TYPE (DMD); affected, 46,XY NIH Approval #: Available: Yes Embryo from U.S.: Yes Embryo Donated in Year(s): 2006 Provider Name: Reproductive Genetics Institute Provider Phone: 773-472-4900 ext.2158 Provider Email: [email protected] Provider URL: http://www.reproductiveqenetics.com/ Provider Restrictions: cell line limited for research purposes by Material Transfer Agreement and cannot be used for experiment nuclear transfer and chimera production NIH Restrictions: Additional Information: Line#11: RG-288; CYSTIC FIBROSIS (CF), affected (deltaF508/deltaF508), 46,XY NIH Approval #: Available: Yes Embryo from U.S.: Yes Embryo Donated in Year(s): 2006 Provider Name: Reproductive Genetics Institute Provider Phone: 773-472-4900 ext.2158 Provider Email: [email protected] Provider URL: http://www.reproductiveqenetics.com/ Provider Restrictions: cell line limited for research purposes by Material Transfer Agreement and cannot be used for experiment nuclear transfer and chimera production NIH Restrictions: Additional Information: Line #12: RG-289; CYSTIC FIBROSIS (CF), affected (deltaF508/de!taF508), 46,XX NIH Approval #: Available: Yes Embryo from U.S.: Yes Embryo Donated in Year(s): 2006 Provider Name: Reproductive Genetics Institute Provider Phone: 773-472-4900 ext.2158 http://hescregapp.od.nih.gov/login/list.htm?DetailList=ves&id=22 4/21/2010 List Page - hESC Registry Application Database Page 5 of 10 Provider Email: [email protected] Provider URL: http://www.reproductivegenetics.com/ Provider Restrictions: cell line limited for research purposes by Material Transfer Agreement and cannot be used for experiment nuclear transfer and chimera production NIH Restrictions: Additional Information: Line #13: RG-301; MUSCULAR DYSTROPHY, DUCHENNE TYPE (DMD) affected, 46,XY NIH Approval #: Available: Yes Embryo from U.S.: Yes Embryo Donated in Year(s): 2006 Provider Name: Reproductive Genetics Institute Provider Phone: 773-472-4900 ext.2158 Provider Email: [email protected] Provider URL: http://www.reproductiveqenetics.com/ Provider Restrictions: cell line limited for research purposes by Material Transfer Agreement and cannot be used for experiment nuclear transfer and chimera production NIH Restrictions: Additional Information: Line #14: RG-302; MUSCULAR DYSTROPHY, DUCHENNE TYPE (DMD), carrier, 46,XX NIH Approval #: Available: Yes Embryo from U.S.: Yes Embryo Donated in Year(s): 2006 Provider Name: Reproductive Genetics Institute Provider