Quantification of the islet product: presentation of a standardized current good manufacturing practices compliant system with minimal variability.

Abstract:

BACKGROUND:Accurate islet quantification has proven difficult to standardize in a good manufacturing practices (GMP) approved manner. METHODS:The influence of assessment variables from both manual and computer-assisted digital image analysis (DIA) methods were compared using calibrated, standardized microspheres or islets alone. Additionally, a mixture of microspheres and exocrine tissue was used to evaluate the variability of both the current, internationally recognized, manual method and a novel GMP-friendly purity- and volume-based method (PV) evaluated by DIA in a semiclosed, culture bag system. RESULTS:Computer-assisted DIA recorded known microsphere size distribution and quantities accurately. By using DIA to evaluate islets, the interindividual manually evaluated percent coefficients of variation (CV%; n=14) were reduced by almost half for both islet equivalents (IEs; 31% vs. 17%, P=0.002) and purity (20% vs. 13%, P=0.033). The microsphere pool mixed with exocrine tissue did not differ from expected IE with either method. However, manual IE resulted in a total CV% of 44.3% and a range spanning 258 k IE, whereas PV resulted in CV% of 10.7% and range of 60 k IE. Purity CV% for each method were similar approximating 10.5% and differed from expected by +7% for the manual method and +3% for PV. CONCLUSION:The variability of standard counting methods for islet samples and clinical quantities of microspheres mixed with exocrine tissue were reduced with DIA. They were reduced even further by use of a semiclosed bag system compared with standard manual counting, thereby facilitating the standardization of islet evaluation according to GMP standards.

journal_name

Transplantation

journal_title

Transplantation

authors

Friberg AS,Brandhorst H,Buchwald P,Goto M,Ricordi C,Brandhorst D,Korsgren O

doi

10.1097/TP.0b013e31820ae48e

subject

Has Abstract

pub_date

2011-03-27 00:00:00

pages

677-83

issue

6

eissn

0041-1337

issn

1534-6080

journal_volume

91

pub_type

杂志文章
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    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199311000-00013

    authors: Hertenstein B,Wiesneth M,Novotny J,Bunjes D,Stefanic M,Heinze B,Hübner G,Heimpel H,Arnold R

    更新日期:1993-11-01 00:00:00

  • Purified Human Skeletal Muscle-Derived Stem Cells Enhance the Repair and Regeneration in the Damaged Urethra.

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    authors: Nakajima N,Tamaki T,Hirata M,Soeda S,Nitta M,Hoshi A,Terachi T

    更新日期:2017-10-01 00:00:00

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    authors: Van Thiel DH,Finkel R,Friedlander L,Gavaler JS,Wright HI,Gordon R

    更新日期:1992-08-01 00:00:00

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    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/01.tp.0000232693.69773.42

    authors: Lunsford SL,Simpson KS,Chavin KD,Menching KJ,Miles LG,Shilling LM,Smalls GR,Baliga PK

    更新日期:2006-10-15 00:00:00

  • Thrombin inhibition in an ex vivo model of porcine heart xenograft hyperacute rejection.

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    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199603270-00003

    authors: Robson SC,Young VK,Cook NS,Metternich R,Kasper-Konig W,Lesnikoski BA,Pierson RN 3rd,Hancock WW,Candinas D,White DJ,Bach FH

    更新日期:1996-03-27 00:00:00

  • Transcriptional inhibition of insulin by FK506 and possible involvement of FK506 binding protein-12 in pancreatic beta-cell.

    abstract::FK506 (tacrolimus) is a strong immunosuppressant: it has been approved as a drug for liver transplantation in Japan, the United States, and the United Kingdom. One of its main adverse effects is hyperglycemia. Thus, in this study, we investigated the mechanism and the reversibility of the hyperglycemia caused by FK506...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:

    authors: Tamura K,Fujimura T,Tsutsumi T,Nakamura K,Ogawa T,Atumaru C,Hirano Y,Ohara K,Ohtsuka K,Shimomura K

    更新日期:1995-06-15 00:00:00

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    journal_title:Transplantation

    pub_type: 临床试验,杂志文章,随机对照试验

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    authors: Jain AB,Hamad I,Rakela J,Dodson F,Kramer D,Demetris J,McMichael J,Starzl TE,Fung JJ

    更新日期:1998-11-27 00:00:00

  • CD4+CD45RO+CD25-/lowCD127+: CD4+CD45RO+CD25hiCD127-/low Ratio in Peripheral Blood: A Useful Biomarker to Detect Cardiac Allograft Vasculopathy in Heart Transplanted Patients.

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    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/TP.0000000000000493

    authors: Roldán C,Mirabet S,Cecilia C,Brossa V,Roig E,Martín C,Gelpí C

    更新日期:2015-07-01 00:00:00

  • Comparison of University of Wisconsin and St Thomas' Hospital solutions on endothelium-derived hyperpolarizing factor-mediated function in coronary micro-arteries.

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    journal_title:Transplantation

    pub_type: 杂志文章

    doi:

    authors: Ge ZD,He GW

    更新日期:2000-07-15 00:00:00

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    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199306000-00025

    authors: Wells A,Larsson E,Hanás E,Laurent T,Hällgren R,Tufveson G

    更新日期:1993-06-01 00:00:00

  • IL-33 prolongs murine cardiac allograft survival through induction of TH2-type immune deviation.

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    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/TP.0b013e3181d720af

    authors: Yin H,Li XY,Jin XB,Zhang BB,Gong Q,Yang H,Zheng F,Gong FL,Zhu JY

    更新日期:2010-05-27 00:00:00

  • Islets in alginate macrobeads reverse diabetes despite minimal acute insulin secretory responses.

    abstract:BACKGROUND:Encapsulation of islets has been widely investigated as a treatment for diabetes. The characteristics and dynamics of insulin secretion by encapsulated islets in response to glucose and other secretagogues are not well understood. METHODS:In our study, macroencapsulated syngeneic islets at 3-4 wk after tran...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-200101270-00006

    authors: Trivedi N,Keegan M,Steil GM,Hollister-Lock J,Hasenkamp WM,Colton CK,Bonner-Weir S,Weir GC

    更新日期:2001-01-27 00:00:00

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    journal_title:Transplantation

    pub_type: 杂志文章

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    authors: Matsumoto Y,McCaughan GW,Painter DM,Bishop GA

    更新日期:1993-07-01 00:00:00

  • The antiproliferative effect of cyclosporine on hematopoietic and lymphoblastoid cell lines--common mechanistic elements with interferon-alpha.

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    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199106000-00025

    authors: Yonish-Rouach E,Kimchi A,Rubinstein M

    更新日期:1991-06-01 00:00:00

  • Hydrogen-rich University of Wisconsin solution attenuates renal cold ischemia-reperfusion injury.

    abstract:BACKGROUND:Renal ischemia-reperfusion (I/R) injury is unavoidable in kidney transplantation and frequently influences both short- and long-term allograft survival rates. One of the major events in I/R injury is the generation of cytotoxic oxygen radicals. Recently, hydrogen gas has been reported to display antioxidant ...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/TP.0b013e318255f8be

    authors: Abe T,Li XK,Yazawa K,Hatayama N,Xie L,Sato B,Kakuta Y,Tsutahara K,Okumi M,Tsuda H,Kaimori JY,Isaka Y,Natori M,Takahara S,Nonomura N

    更新日期:2012-07-15 00:00:00

  • Defining delayed graft function after renal transplantation: simplest is best.

    abstract:BACKGROUND:Delayed graft function (DGF) after renal transplantation can be diagnosed according to several different definitions, complicating comparison between studies that use DGF as an endpoint. This is a particular problem after transplantation with kidneys from donation after circulatory death (DCD) kidneys, becau...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/TP.0b013e3182a19348

    authors: Mallon DH,Summers DM,Bradley JA,Pettigrew GJ

    更新日期:2013-11-27 00:00:00

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    abstract::Graft and patient survival rates after transplantation of ABO-incompatible liver allografts have been poor. We used plasmapheresis and a potent immunosuppressive regimen to control hemagglutinin levels and prevent early rejection. Ten patients who had a United Network for Organ Sharing status of 4 received ABO-incompa...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199504150-00011

    authors: Mor E,Skerrett D,Manzarbeitia C,Sheiner PA,Schwartz ME,Emre S,Thung SN,Miller CM

    更新日期:1995-04-15 00:00:00

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    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-197909000-00012

    authors: Kripke ML,Thorn RM,Lill PH,Civin CI,Pazmiño NH,Fisher MS

    更新日期:1979-09-01 00:00:00

  • Incidence of tuberculosis in deceased-organ donors and transmission risk to recipients in Spain.

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    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/TP.0b013e3182977adf

    authors: Coll E,Torre-Cisneros J,Calvo R,Garrido G,Matesanz R

    更新日期:2013-07-27 00:00:00

  • Pulmonary bronchoalveolar cell and protein kinetics in dogs given total-body irradiation, autologous marrow grafts, and methotrexate.

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    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-198404000-00003

    authors: Springmeyer SC,Kopecky KJ,Deeg HJ,Whitehead J,Altman LC,Storb R

    更新日期:1984-04-01 00:00:00

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    journal_title:Transplantation

    pub_type: 杂志文章,多中心研究

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    更新日期:2008-11-15 00:00:00

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    journal_title:Transplantation

    pub_type: 杂志文章,评审

    doi:10.1097/TP.0b013e31826d4672

    authors: Kinnear G,Jones ND,Wood KJ

    更新日期:2013-02-27 00:00:00

  • The effect of acute rejection and cyclosporin A-treatment on induction of platelet-derived growth factor and its receptors during the development of chronic rat renal allograft rejection.

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    pub_type: 杂志文章

    doi:10.1097/00007890-200202270-00003

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    更新日期:2002-02-27 00:00:00

  • Human herpesvirus 6 infection after allogeneic stem cell transplantation: incidence, outcome, and factors associated with HHV-6 reactivation.

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    pub_type: 杂志文章

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    authors: Jeulin H,Agrinier N,Guery M,Salmon A,Clément L,Bordigoni P,Venard V

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  • Donor treatment with mycophenolate mofetil: protection against ischemia-reperfusion injury in the rat.

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  • Kidney Transplant in the Era of Modern Therapy for Multiple Myeloma.

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    journal_title:Transplantation

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    authors: Kirkman RL,Shapiro ME,Carpenter CB,McKay DB,Milford EL,Ramos EL,Tilney NL,Waldmann TA,Zimmerman CE,Strom TB

    更新日期:1991-01-01 00:00:00

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    pub_type: 杂志文章

    doi:10.1097/00007890-199612150-00028

    authors: Fox RJ,Vogelsang GB,Beschorner WE

    更新日期:1996-12-15 00:00:00

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    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-198504000-00004

    authors: Hewitt CW,Black KS,Fraser LA,Howard EB,Martin DC,Achauer BM,Furnas DW

    更新日期:1985-04-01 00:00:00

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    pub_type: 杂志文章

    doi:10.1097/TP.0b013e3181d98c0f

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    更新日期:2010-06-15 00:00:00