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Phase 3 trial of human islet-after-kidney transplantation in type 1 diabetes.

Publication ,  Journal Article
Markmann, JF; Rickels, MR; Eggerman, TL; Bridges, ND; Lafontant, DE; Qidwai, J; Foster, E; Clarke, WR; Kamoun, M; Alejandro, R; Bellin, MD ...
Published in: Am J Transplant
April 2021

Allogeneic islet transplant offers a minimally invasive option for β cell replacement in the treatment of type 1 diabetes (T1D). The CIT consortium trial of purified human pancreatic islets (PHPI) in patients with T1D after kidney transplant (CIT06), a National Institutes of Health-sponsored phase 3, prospective, open-label, single-arm pivotal trial of PHPI, was conducted in 24 patients with impaired awareness of hypoglycemia while receiving intensive insulin therapy. PHPI were manufactured using standardized processes. PHPI transplantation was effective with 62.5% of patients achieving the primary endpoint of freedom from severe hypoglycemic events and HbA1c  ≤ 6.5% or reduced by ≥ 1 percentage point at 1 year posttransplant. Median HbA1c declined from 8.1% before to 6.0% at 1 year and 6.3% at 2 and 3 years following transplant (P < .001 for all vs baseline), with related improvements in hypoglycemia awareness and glucose variability. The improved metabolic control was associated with better health-related and diabetes-related quality of life. The procedure was safe and kidney allograft function remained stable after 3 years. These results add to evidence establishing allogeneic islet transplant as a safe and effective treatment for patients with T1D and unstable glucose control despite intensive insulin treatment, supporting the indication for PHPI in the post-renal transplant setting.

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Published In

Am J Transplant

DOI

EISSN

1600-6143

Publication Date

April 2021

Volume

21

Issue

4

Start / End Page

1477 / 1492

Location

United States

Related Subject Headings

  • Surgery
  • Quality of Life
  • Prospective Studies
  • Kidney Transplantation
  • Islets of Langerhans Transplantation
  • Insulin
  • Humans
  • Diabetes Mellitus, Type 1
  • Blood Glucose
  • 3204 Immunology
 

Citation

APA
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Markmann, J. F., Rickels, M. R., Eggerman, T. L., Bridges, N. D., Lafontant, D. E., Qidwai, J., … Turgeon, N. A. (2021). Phase 3 trial of human islet-after-kidney transplantation in type 1 diabetes. Am J Transplant, 21(4), 1477–1492. https://doi.org/10.1111/ajt.16174
Markmann, James F., Michael R. Rickels, Thomas L. Eggerman, Nancy D. Bridges, David E. Lafontant, Julie Qidwai, Eric Foster, et al. “Phase 3 trial of human islet-after-kidney transplantation in type 1 diabetes.Am J Transplant 21, no. 4 (April 2021): 1477–92. https://doi.org/10.1111/ajt.16174.
Markmann JF, Rickels MR, Eggerman TL, Bridges ND, Lafontant DE, Qidwai J, et al. Phase 3 trial of human islet-after-kidney transplantation in type 1 diabetes. Am J Transplant. 2021 Apr;21(4):1477–92.
Markmann, James F., et al. “Phase 3 trial of human islet-after-kidney transplantation in type 1 diabetes.Am J Transplant, vol. 21, no. 4, Apr. 2021, pp. 1477–92. Pubmed, doi:10.1111/ajt.16174.
Markmann JF, Rickels MR, Eggerman TL, Bridges ND, Lafontant DE, Qidwai J, Foster E, Clarke WR, Kamoun M, Alejandro R, Bellin MD, Chaloner K, Czarniecki CW, Goldstein JS, Hering BJ, Hunsicker LG, Kaufman DB, Korsgren O, Larsen CP, Luo X, Naji A, Oberholzer J, Posselt AM, Ricordi C, Senior PA, Shapiro AMJ, Stock PG, Turgeon NA. Phase 3 trial of human islet-after-kidney transplantation in type 1 diabetes. Am J Transplant. 2021 Apr;21(4):1477–1492.
Journal cover image

Published In

Am J Transplant

DOI

EISSN

1600-6143

Publication Date

April 2021

Volume

21

Issue

4

Start / End Page

1477 / 1492

Location

United States

Related Subject Headings

  • Surgery
  • Quality of Life
  • Prospective Studies
  • Kidney Transplantation
  • Islets of Langerhans Transplantation
  • Insulin
  • Humans
  • Diabetes Mellitus, Type 1
  • Blood Glucose
  • 3204 Immunology