Phase 3 Trial of Transplantation of Human Islets in Type 1 Diabetes Complicated by Severe Hypoglycemia

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Phase 3 Trial of Transplantation of Human Islets in Type 1 Diabetes Complicated by Severe Hypoglycemia

Hering, Bernhard J. (author): Univ Minnesota, Schulze Diabet Inst, Minneapolis, MN 55455 USA.;Univ Minnesota, Dept Surg, Box 242 UMHC, Minneapolis, MN 55455 USA.

Clarke, William R. (author): Univ Iowa, Clin Trials Stat & Data Management Ctr, Iowa City, IA USA.

Bridges, Nancy D. (author): NIAID, NIH, 9000 Rockville Pike, Bethesda, MD 20892 USA.

Eggerman, Thomas L. (author): NIDDK, NIH, Bethesda, MD 20892 USA.

Alejandro, Rodolfo (author): Univ Miami, Miller Sch Med, Diabet Res Inst, Miami, FL 33136 USA.

Bellin, Melena D. (author): Univ Minnesota, Schulze Diabet Inst, Minneapolis, MN 55455 USA.;Univ Minnesota, Dept Pediat, Minneapolis, MN 55455 USA.

Chaloner, Kathryn (author): Univ Iowa, Clin Trials Stat & Data Management Ctr, Iowa City, IA USA.

Czarniecki, Christine W. (author): NIAID, NIH, 9000 Rockville Pike, Bethesda, MD 20892 USA.

Goldstein, Julia S. (author): NIAID, NIH, 9000 Rockville Pike, Bethesda, MD 20892 USA.

Hunsicker, Lawrence G. (author): Univ Iowa, Clin Trials Stat & Data Management Ctr, Iowa City, IA USA.

Kaufman, Dixon B. (author): Univ Wisconsin, Dept Surg, Div Transplantat, Madison, WI USA.

Korsgren, Olle (author): Uppsala universitet,Klinisk immunologi

Larsen, Christian P. (author): Emory Univ, Emory Transplant Ctr, Atlanta, GA 30322 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, Perelman Sch Med, Dept Surg, Philadelphia, PA 19104 USA.;Univ Penn, Perelman Sch Med, Dept Med, Philadelphia, PA 19104 USA.

Oberholzer, Jose (author): Univ Illinois Hosp & Hlth Sci Syst, Div Transplantat, Chicago, IL USA.

Posselt, Andrew M. (author): Univ Calif San Francisco, Dept Surg, San Francisco, CA USA.

Rickels, Michael R. (author): Univ Penn, Perelman Sch Med, Inst Diabet Obes & Metab, Philadelphia, PA 19104 USA.;Univ Penn, Perelman Sch Med, Dept Surg, Philadelphia, PA 19104 USA.;Univ Penn, Perelman Sch Med, Dept Med, Philadelphia, PA 19104 USA.

Ricordi, Camillo (author): Univ Miami, Miller Sch Med, Diabet Res Inst, Miami, FL 33136 USA.

Robien, Mark A. (author): NIAID, NIH, 9000 Rockville Pike, Bethesda, MD 20892 USA.

Senior, Peter A. (author): Univ Alberta, Clin Islet Transplant Program, Edmonton, AB, Canada.;Univ Alberta, Fac Med & Dent, Edmonton, AB, Canada.

Shapiro, A. M. James (author): Univ Alberta, Clin Islet Transplant Program, Edmonton, AB, Canada.;Univ Alberta, Fac Med & Dent, Edmonton, AB, Canada.

Stock, Peter G. (author): Univ Calif San Francisco, Dept Surg, San Francisco, CA USA.

Turgeon, Nicole A. (author): Emory Univ, Emory Transplant Ctr, Atlanta, GA 30322 USA.

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Univ Minnesota, Schulze Diabet Inst, Minneapolis, MN 55455 USA;Univ Minnesota, Dept Surg, Box 242 UMHC, Minneapolis, MN 55455 USA. Univ Iowa, Clin Trials Stat & Data Management Ctr, Iowa City, IA USA. (creator_code:org_t)

2016-04-18
2016
English.
In: Diabetes Care. - : American Diabetes Association. - 0149-5992 .- 1935-5548. ; 39:7, s. 1230-1240

Related links:: https://care.diabete...; show more...; https://urn.kb.se/re...; https://doi.org/10.2...; show less...

Journal article (peer-reviewed)

Abstract Subject headings

OBJECTIVE Impaired awareness of hypoglycemia (IAH) and severe hypoglycemic events (SHEs) cause substantial morbidity and mortality in patients with type 1 diabetes (T1D). Current therapies are effective in preventing SHEs in 50-80% of patients with IAH and SHEs, leaving a substantial number of patients at risk. We evaluated the effectiveness and safety of a standardized human pancreatic islet product in subjects in whom IAH and SHEs persisted despite medical treatment. RESEARCH DESIGN AND METHODS This multicenter, single-arm, phase 3 study of the investigational product purified human pancreatic islets (PHPI) was conducted at eight centers in North America. Forty-eight adults with T1D for >5 years, absent stimulated C-peptide, and documented IAH and SHEs despite expert care were enrolled. Each received immunosuppression and one or more transplants of PHPI, manufactured on-site under good manufacturing practice conditions using a common batch record and standardized lot release criteria and test methods. The primary end point was the achievement of HbA(1c) <7.0% (53 mmol/mol) at day 365 and freedom from SHEs from day 28 to day 365 after the first transplant. RESULTS The primary end point was successfully met by 87.5% of subjects at 1 year and by 71% at 2 years. The median HbA(1c) level was 5.6% (38 mmol/mol) at both 1 and 2 years. Hypoglycemia awareness was restored, with highly significant improvements in Clarke and HYPO scores (P > 0.0001). No study-related deaths or disabilities occurred. Five of the enrollees (10.4%) experienced bleeds requiring transfusions (corresponding to 5 of 75 procedures), and two enrollees (4.1%) had infections attributed to immunosuppression. Glomerular filtration rate decreased significantly on immunosuppression, and donor-specific antibodies developed in two patients. CONCLUSIONS Transplanted PHPI provided glycemic control, restoration of hypoglycemia awareness, and protection from SHEs in subjects with intractable IAH and SHEs. Safety events occurred related to the infusion procedure and immunosuppression, including bleeding and decreased renal function. Islet transplantation should be considered for patients with T1D and IAH in whom other, less invasive current treatments have been ineffective in preventing SHEs.

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MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Endocrinology an ...

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Phase 3 Trial of Transplantation of Human Islets in Type 1 Diabetes Complicated by Severe Hypoglycemia

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