Long-Term Follow-Up of the Edmonton Protocol of Islet Transplantation in the United States

Daniel C. Brennan, H. A. Kopetskie, P. H. Sayre, Rodolfo Alejandro, E. Cagliero, A. M J Shapiro, J. S. Goldstein, M. R. Desmarais, S. Booher, P. J. Bianchine

Research output: Contribution to journalArticle

56 Citations (Scopus)

Abstract

We report the long-term follow-up of the efficacy and safety of islet transplantation in seven type 1 diabetic subjects from the United States enrolled in the multicenter international Edmonton Protocol who had persistent islet function after completion of the Edmonton Protocol. Subjects were followed up to 12 years with serial testing for sustained islet allograft function as measured by C-peptide. All seven subjects demonstrated continued islet function longer than a decade from the time of first islet transplantation. One subject remained insulin independent without the need for diabetic medications or supplemental transplants. One subject who was insulin-independent for over 8 years experienced graft failure 10.9 years after the first islet transplant. The remaining six subjects demonstrated continued islet function upon trial completion, although three had received a supplemental islet transplant each. At trial completion, five subjects were receiving insulin and two remained insulin independent, although one was treated with liraglutide. The median hemoglobin A1c was 6.3% (45 mmol/mol). All subjects experienced progressive decline in the C-peptide/glucose ratio. No patients experienced severe hypoglycemia, opportunistic infection, or lymphoma. Thus, although the rate and duration of insulin independence was low, the Edmonton Protocol was safe in the long term. Alternative approaches to islet transplantation are under investigation.

Original languageEnglish (US)
Pages (from-to)509-517
Number of pages9
JournalAmerican Journal of Transplantation
Volume16
Issue number2
DOIs
StatePublished - Feb 1 2016

Fingerprint

Islets of Langerhans Transplantation
Insulin
Transplants
C-Peptide
Opportunistic Infections
Hypoglycemia
Allografts
Lymphoma
Hemoglobins
Safety
Glucose

Keywords

  • Discipline: islet transplantation
  • Focus: clinical trial, immunosuppressive regimens
  • Scope: clinical research/practice

ASJC Scopus subject areas

  • Transplantation
  • Immunology and Allergy
  • Pharmacology (medical)

Cite this

Brennan, D. C., Kopetskie, H. A., Sayre, P. H., Alejandro, R., Cagliero, E., Shapiro, A. M. J., ... Bianchine, P. J. (2016). Long-Term Follow-Up of the Edmonton Protocol of Islet Transplantation in the United States. American Journal of Transplantation, 16(2), 509-517. https://doi.org/10.1111/ajt.13458

Long-Term Follow-Up of the Edmonton Protocol of Islet Transplantation in the United States. / Brennan, Daniel C.; Kopetskie, H. A.; Sayre, P. H.; Alejandro, Rodolfo; Cagliero, E.; Shapiro, A. M J; Goldstein, J. S.; Desmarais, M. R.; Booher, S.; Bianchine, P. J.

In: American Journal of Transplantation, Vol. 16, No. 2, 01.02.2016, p. 509-517.

Research output: Contribution to journalArticle

Brennan, DC, Kopetskie, HA, Sayre, PH, Alejandro, R, Cagliero, E, Shapiro, AMJ, Goldstein, JS, Desmarais, MR, Booher, S & Bianchine, PJ 2016, 'Long-Term Follow-Up of the Edmonton Protocol of Islet Transplantation in the United States', American Journal of Transplantation, vol. 16, no. 2, pp. 509-517. https://doi.org/10.1111/ajt.13458
Brennan, Daniel C. ; Kopetskie, H. A. ; Sayre, P. H. ; Alejandro, Rodolfo ; Cagliero, E. ; Shapiro, A. M J ; Goldstein, J. S. ; Desmarais, M. R. ; Booher, S. ; Bianchine, P. J. / Long-Term Follow-Up of the Edmonton Protocol of Islet Transplantation in the United States. In: American Journal of Transplantation. 2016 ; Vol. 16, No. 2. pp. 509-517.
@article{0f90d6a824754c7998d7d4d63b579e70,
title = "Long-Term Follow-Up of the Edmonton Protocol of Islet Transplantation in the United States",
abstract = "We report the long-term follow-up of the efficacy and safety of islet transplantation in seven type 1 diabetic subjects from the United States enrolled in the multicenter international Edmonton Protocol who had persistent islet function after completion of the Edmonton Protocol. Subjects were followed up to 12 years with serial testing for sustained islet allograft function as measured by C-peptide. All seven subjects demonstrated continued islet function longer than a decade from the time of first islet transplantation. One subject remained insulin independent without the need for diabetic medications or supplemental transplants. One subject who was insulin-independent for over 8 years experienced graft failure 10.9 years after the first islet transplant. The remaining six subjects demonstrated continued islet function upon trial completion, although three had received a supplemental islet transplant each. At trial completion, five subjects were receiving insulin and two remained insulin independent, although one was treated with liraglutide. The median hemoglobin A1c was 6.3{\%} (45 mmol/mol). All subjects experienced progressive decline in the C-peptide/glucose ratio. No patients experienced severe hypoglycemia, opportunistic infection, or lymphoma. Thus, although the rate and duration of insulin independence was low, the Edmonton Protocol was safe in the long term. Alternative approaches to islet transplantation are under investigation.",
keywords = "Discipline: islet transplantation, Focus: clinical trial, immunosuppressive regimens, Scope: clinical research/practice",
author = "Brennan, {Daniel C.} and Kopetskie, {H. A.} and Sayre, {P. H.} and Rodolfo Alejandro and E. Cagliero and Shapiro, {A. M J} and Goldstein, {J. S.} and Desmarais, {M. R.} and S. Booher and Bianchine, {P. J.}",
year = "2016",
month = "2",
day = "1",
doi = "10.1111/ajt.13458",
language = "English (US)",
volume = "16",
pages = "509--517",
journal = "American Journal of Transplantation",
issn = "1600-6135",
publisher = "Wiley-Blackwell",
number = "2",

}

TY - JOUR

T1 - Long-Term Follow-Up of the Edmonton Protocol of Islet Transplantation in the United States

AU - Brennan, Daniel C.

AU - Kopetskie, H. A.

AU - Sayre, P. H.

AU - Alejandro, Rodolfo

AU - Cagliero, E.

AU - Shapiro, A. M J

AU - Goldstein, J. S.

AU - Desmarais, M. R.

AU - Booher, S.

AU - Bianchine, P. J.

PY - 2016/2/1

Y1 - 2016/2/1

N2 - We report the long-term follow-up of the efficacy and safety of islet transplantation in seven type 1 diabetic subjects from the United States enrolled in the multicenter international Edmonton Protocol who had persistent islet function after completion of the Edmonton Protocol. Subjects were followed up to 12 years with serial testing for sustained islet allograft function as measured by C-peptide. All seven subjects demonstrated continued islet function longer than a decade from the time of first islet transplantation. One subject remained insulin independent without the need for diabetic medications or supplemental transplants. One subject who was insulin-independent for over 8 years experienced graft failure 10.9 years after the first islet transplant. The remaining six subjects demonstrated continued islet function upon trial completion, although three had received a supplemental islet transplant each. At trial completion, five subjects were receiving insulin and two remained insulin independent, although one was treated with liraglutide. The median hemoglobin A1c was 6.3% (45 mmol/mol). All subjects experienced progressive decline in the C-peptide/glucose ratio. No patients experienced severe hypoglycemia, opportunistic infection, or lymphoma. Thus, although the rate and duration of insulin independence was low, the Edmonton Protocol was safe in the long term. Alternative approaches to islet transplantation are under investigation.

AB - We report the long-term follow-up of the efficacy and safety of islet transplantation in seven type 1 diabetic subjects from the United States enrolled in the multicenter international Edmonton Protocol who had persistent islet function after completion of the Edmonton Protocol. Subjects were followed up to 12 years with serial testing for sustained islet allograft function as measured by C-peptide. All seven subjects demonstrated continued islet function longer than a decade from the time of first islet transplantation. One subject remained insulin independent without the need for diabetic medications or supplemental transplants. One subject who was insulin-independent for over 8 years experienced graft failure 10.9 years after the first islet transplant. The remaining six subjects demonstrated continued islet function upon trial completion, although three had received a supplemental islet transplant each. At trial completion, five subjects were receiving insulin and two remained insulin independent, although one was treated with liraglutide. The median hemoglobin A1c was 6.3% (45 mmol/mol). All subjects experienced progressive decline in the C-peptide/glucose ratio. No patients experienced severe hypoglycemia, opportunistic infection, or lymphoma. Thus, although the rate and duration of insulin independence was low, the Edmonton Protocol was safe in the long term. Alternative approaches to islet transplantation are under investigation.

KW - Discipline: islet transplantation

KW - Focus: clinical trial, immunosuppressive regimens

KW - Scope: clinical research/practice

UR - http://www.scopus.com/inward/record.url?scp=84957946584&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84957946584&partnerID=8YFLogxK

U2 - 10.1111/ajt.13458

DO - 10.1111/ajt.13458

M3 - Article

C2 - 26433206

AN - SCOPUS:84957946584

VL - 16

SP - 509

EP - 517

JO - American Journal of Transplantation

JF - American Journal of Transplantation

SN - 1600-6135

IS - 2

ER -