SwePub
Tyck till om SwePub Sök här!
Sök i LIBRIS databas

  Extended search

L773:0012 1797 OR L773:1939 327X
 

Search: L773:0012 1797 OR L773:1939 327X > (2015-2019) > Korsgren Olle > Ricordi Camillo > National Institutes...

  • 1 of 1
  • Previous record
  • Next record
  •    To hitlist

National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial : Manufacture of a Complex Cellular Product at Eight Processing Facilities

Ricordi, Camillo (author)
Univ Miami, Miller Sch Med, Diabet Res Inst, Miami, FL 33136 USA.
Goldstein, Julia S. (author)
NIAID, NIH, 9000 Rockville Pike, Bethesda, MD 20892 USA.
Balamurugan, A. N. (author)
Univ Minnesota, Schulze Diabet Inst, Minneapolis, MN USA.;Univ Minnesota, Dept Surg, Box 242 UMHC, Minneapolis, MN 55455 USA.;Univ Louisville, Dept Surg, Islet Cell Lab, Cardiovasc Innovat Inst, Louisville, KY 40292 USA.
show more...
Szot, Gregory L. (author)
Univ Calif San Francisco, Dept Surg, San Francisco, CA USA.
Kin, Tatsuya (author)
Univ Alberta, Clin Islet Transplant Program, Edmonton, AB, Canada.;Univ Alberta, Fac Med & Dent, Edmonton, AB, Canada.
Liu, Chengyang (author)
Univ Penn, Perelman Sch Med, Inst Diabet Obes & Metab, Philadelphia, PA 19104 USA.;Univ Penn, Dept Surg, Perelman Sch Med, Philadelphia, PA 19104 USA.;Univ Penn, Dept Med, Perelman Sch Med, Philadelphia, PA 19104 USA.
Czarniecki, Christine W. (author)
NIAID, NIH, 9000 Rockville Pike, Bethesda, MD 20892 USA.
Barbaro, Barbara (author)
Univ Illinois Hosp & Hlth Sci Syst, Div Transplantat, Chicago, IL USA.
Bridges, Nancy D. (author)
NIAID, NIH, 9000 Rockville Pike, Bethesda, MD 20892 USA.
Cano, Jose (author)
Emory Univ, Dept Surg, Emory Transplant Ctr, Div Transplantat, Atlanta, GA 30322 USA.
Clarke, William R. (author)
Univ Iowa, Clin Trials Stat & Data Management Ctr, Iowa City, IA USA.
Eggerman, Thomas L. (author)
NIDDK, NIH, Bethesda, MD 20892 USA.
Hunsicker, Lawrence G. (author)
Univ Iowa, Clin Trials Stat & Data Management Ctr, Iowa City, IA USA.
Kaufman, Dixon B. (author)
Northwestern Univ, Feinberg Sch Med, Comprehens Transplant Ctr, Chicago, IL 60611 USA.;Univ Wisconsin, Madison, WI USA.
Khan, Aisha (author)
Univ Miami, Miller Sch Med, Diabet Res Inst, Miami, FL 33136 USA.
Lafontant, David-Erick (author)
Univ Iowa, Clin Trials Stat & Data Management Ctr, Iowa City, IA USA.
Linetsky, Elina (author)
Univ Miami, Miller Sch Med, Diabet Res Inst, Miami, FL 33136 USA.
Luo, Xunrong (author)
Northwestern Univ, Feinberg Sch Med, Comprehens Transplant Ctr, Chicago, IL 60611 USA.
Markmann, James F. (author)
Harvard Med Sch, Massachusetts Gen Hosp, Div Transplant Surg, Boston, MA USA.
Naji, Ali (author)
Univ Penn, Perelman Sch Med, Inst Diabet Obes & Metab, Philadelphia, PA 19104 USA.;Univ Penn, Dept Surg, Perelman Sch Med, Philadelphia, PA 19104 USA.;Univ Penn, Dept Med, Perelman Sch Med, Philadelphia, PA 19104 USA.
Korsgren, Olle (author)
Uppsala universitet,Klinisk immunologi
Oberholzer, Jose (author)
Univ Illinois Hosp & Hlth Sci Syst, Div Transplantat, Chicago, IL USA.
Turgeon, Nicole A. (author)
Emory Univ, Dept Surg, Emory Transplant Ctr, Div Transplantat, Atlanta, GA 30322 USA.
Brandhorst, Daniel (author)
Uppsala universitet,Klinisk immunologi
Friberg, Andrew S. (author)
Uppsala universitet,Klinisk immunologi
Lei, Ji (author)
Harvard Med Sch, Massachusetts Gen Hosp, Div Transplant Surg, Boston, MA USA.
Wang, Ling-jia (author)
Northwestern Univ, Feinberg Sch Med, Comprehens Transplant Ctr, Chicago, IL 60611 USA.
Wilhelm, Joshua J. (author)
Univ Minnesota, Schulze Diabet Inst, Minneapolis, MN USA.;Univ Minnesota, Dept Surg, Box 242 UMHC, Minneapolis, MN 55455 USA.
Willits, Jamie (author)
Univ Iowa, Clin Trials Stat & Data Management Ctr, Iowa City, IA USA.
Zhang, Xiaomin (author)
Northwestern Univ, Feinberg Sch Med, Comprehens Transplant Ctr, Chicago, IL 60611 USA.
Hering, Bernhard J. (author)
Univ Minnesota, Schulze Diabet Inst, Minneapolis, MN USA.;Univ Minnesota, Dept Surg, Box 242 UMHC, Minneapolis, MN 55455 USA.
Posselt, Andrew M. (author)
Univ Calif San Francisco, Dept Surg, San Francisco, CA USA.
Stock, Peter G. (author)
Univ Calif San Francisco, Dept Surg, San Francisco, CA USA.
Shapiro, A. M. James (author)
Univ Alberta, Clin Islet Transplant Program, Edmonton, AB, Canada.;Univ Alberta, Fac Med & Dent, Edmonton, AB, Canada.
show less...
Univ Miami, Miller Sch Med, Diabet Res Inst, Miami, FL 33136 USA NIAID, NIH, 9000 Rockville Pike, Bethesda, MD 20892 USA. (creator_code:org_t)
2016-07-27
2016
English.
In: Diabetes. - : American Diabetes Association. - 0012-1797 .- 1939-327X. ; 65:11, s. 3418-3428
Related links:
https://diabetes.dia...
show more...
https://urn.kb.se/re...
https://doi.org/10.2...
show less...
  • Journal article (peer-reviewed)
Abstract Subject headings
Close  
  • Eight manufacturing facilities participating in the National Institutes of Health-sponsored Clinical Islet Transplantation (CIT) Consortium jointly developed and implemented a harmonized process for the manufacture of allogeneic purified human pancreatic islet (PHPI) product evaluated in a phase 3 trial in subjects with type 1 diabetes. Manufacturing was controlled by a common master production batch record, standard operating procedures that included acceptance criteria for deceased donor organ pancreata and critical raw materials, PHPI product specifications, certificate of analysis, and test methods. The process was compliant with Current Good Manufacturing Practices and Current Good Tissue Practices. This report describes the manufacturing process for 75 PHPI clinical lots and summarizes the results, including lot release. The results demonstrate the feasibility of implementing a harmonized process at multiple facilities for the manufacture of a complex cellular product. The quality systems and regulatory and operational strategies developed by the CIT Consortium yielded product lots that met the prespecified characteristics of safety, purity, potency, and identity and were successfully transplanted into 48 subjects. No adverse events attributable to the product and no cases of primary nonfunction were observed.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)

Publication and Content Type

ref (subject category)
art (subject category)

Find in a library

  • Diabetes (Search for host publication in LIBRIS)

To the university's database

  • 1 of 1
  • Previous record
  • Next record
  •    To hitlist

Kungliga biblioteket hanterar dina personuppgifter i enlighet med EU:s dataskyddsförordning (2018), GDPR. Läs mer om hur det funkar här.
Så här hanterar KB dina uppgifter vid användning av denna tjänst.

 
pil uppåt Close

Copy and save the link in order to return to this view