PMID- 23061757
OWN - NLM
STAT- MEDLINE
DCOM- 20130328
LR  - 20211203
IS  - 1399-0012 (Electronic)
IS  - 0902-0063 (Print)
IS  - 0902-0063 (Linking)
VI  - 26
IP  - 5
DP  - 2012 Sep-Oct
TI  - Safety and tolerability of the T-cell depletion protocol coupled with anakinra 
      and etanercept for clinical islet cell transplantation.
PG  - E471-84
LID - 10.1111/ctr.12011 [doi]
AB  - BACKGROUND: Islet cell transplantation (ICT) is a promising approach to cure 
      patients with type 1 diabetes. We have implemented a new immunosuppression 
      protocol with antithymoglobulin plus anti-inflammatory agents of anakinra and 
      eternacept for induction and tacrolimus plus mycophenolate mofetil for 
      maintenance [T-cell depletion with anti-inflammatory (TCD-AI) protocol], 
      resulting in successful single-donor ICT. METHODS: Eight islet recipients with 
      type 1 diabetes reported adverse events (AEs) monthly. AEs were compared between 
      three groups: first infusion with the TCD-AI protocol (TCD-AI-1st) and first and 
      second infusion with the Edmonton-type protocol (Edmonton-1st and Edmonton-2nd). 
      RESULTS: The incidence of symptomatic AEs within the initial three months in the 
      TCD-AI-1st group was less than in the Edmonton-1st and Edmonton-2nd groups, with 
      a marginally significant difference (mean +/- SE: 5.5 +/- 0.3, 7.5 +/- 0.5, and 8.3 +/- 
      1.3, respectively; p = 0.07). A significant reduction in liver enzyme elevation 
      after ICT was found in the TCD-AI-1st group compared with the Edmonton-1st and 
      Edmonton-2nd groups (p < 0.05). Because of AEs, all patients in the Edmonton 
      protocol eventually converted to the TCD-AI protocol, whereas all patients 
      tolerated the TCD-AI protocol. CONCLUSIONS: TCD-AI protocol can be tolerated for 
      successful ICT, although this study includes small cohort, and large population 
      trial should be taken.
CI  - (c) 2012 John Wiley & Sons A/S.
FAU - Takita, Morihito
AU  - Takita M
AD  - Islet Cell Laboratory, Baylor Research Institute, Dallas, TX, USA.
FAU - Matsumoto, Shinichi
AU  - Matsumoto S
FAU - Shimoda, Masayuki
AU  - Shimoda M
FAU - Chujo, Daisuke
AU  - Chujo D
FAU - Itoh, Takeshi
AU  - Itoh T
FAU - Sorelle, Jeffrey A
AU  - Sorelle JA
FAU - Purcell, Kerri
AU  - Purcell K
FAU - Onaca, Nicholas
AU  - Onaca N
FAU - Naziruddin, Bashoo
AU  - Naziruddin B
FAU - Levy, Marlon F
AU  - Levy MF
LA  - eng
GR  - R21 DK090513/DK/NIDDK NIH HHS/United States
GR  - 1R21DK090513-01/DK/NIDDK NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PL  - Denmark
TA  - Clin Transplant
JT  - Clinical transplantation
JID - 8710240
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Immunoglobulin G)
RN  - 0 (Immunosuppressive Agents)
RN  - 0 (Interleukin 1 Receptor Antagonist Protein)
RN  - 0 (Receptors, Tumor Necrosis Factor)
RN  - OP401G7OJC (Etanercept)
SB  - IM
MH  - Adult
MH  - Antirheumatic Agents/therapeutic use
MH  - Cohort Studies
MH  - Combined Modality Therapy
MH  - Diabetes Mellitus, Type 1/*therapy
MH  - Etanercept
MH  - Female
MH  - Humans
MH  - Immunoglobulin G/*therapeutic use
MH  - Immunosuppression Therapy
MH  - Immunosuppressive Agents/*therapeutic use
MH  - Interleukin 1 Receptor Antagonist Protein/*therapeutic use
MH  - *Islets of Langerhans Transplantation
MH  - *Lymphocyte Depletion
MH  - Male
MH  - Maximum Tolerated Dose
MH  - Middle Aged
MH  - Prognosis
MH  - Receptors, Tumor Necrosis Factor/*therapeutic use
MH  - T-Lymphocytes/*immunology
PMC - PMC4082563
MID - NIHMS474401
COIS- DISCLOSURES: None of the authors have conflicts of interest related to this 
      manuscript.
EDAT- 2012/10/16 06:00
MHDA- 2013/03/30 06:00
PMCR- 2014/07/05
CRDT- 2012/10/16 06:00
PHST- 2012/10/16 06:00 [entrez]
PHST- 2012/10/16 06:00 [pubmed]
PHST- 2013/03/30 06:00 [medline]
PHST- 2014/07/05 00:00 [pmc-release]
AID - 10.1111/ctr.12011 [doi]
PST - ppublish
SO  - Clin Transplant. 2012 Sep-Oct;26(5):E471-84. doi: 10.1111/ctr.12011.