CITR Results

Patient History

The median age of recipients was 42.2 years with a median occurrence of Type 1 diabetes of 30 years. Their daily insulin requirements prior to the first islet infusion procedure were 35.4?11.5 units with almost 47% of the patients were on an insulin pump. The mean fasting glucose was 160±91.5 mg/dL and the mean HbA_1c was 7.7±1.3.

Processed Islets

For this report, only islet allografts were reported to the CITR (i.e. no autografts or xenotransplants). Median time from cross clamp procedure to pancreas recovery was 27 minutes and duration of cold ischemia was 7 hours. Preservation of the pancreata employted the two-layer UW method of preservation (Matsumoto et al., 2001). Median purity of the recovered "product" was 60%, viability was 95%, and the median stimulation index was 2.0.

Panel 1. Islet Infusion equivalents used by CITR affiliated transplant centers. [ magnify ]

Twenty-eight (28) patients received one (1) islet infusion, 44 patients received two (2) islet infusions, and fourteen 14 received 4 islet infusions (see Table 1 for details on islet equivalents used in procedures). For all, infusion was performed intraportally without an immunobarrier device.

Graft Function

On average, with each additional infusion, _HbA1c levels decreased and C-peptide levels increased. At 6 months (after the last infusion), 61.1% of patients were insulin independent and at 12 months, 57.9% were insulin independent.

Graft Side Effects

All grade 3, 4 and 5 adverse events (according to the Common Terminology Criteria for Adverse Events, CTCAE (Trotti et al., 2003)) were reported to CITR. No deaths have been reported. Of 86 patients, there were 45 adverse events, 58% of which required inpatient hospitalization and almost 27% were reported as life threatening. Details are provided in the report. 

Closing Remarks

The authors rightfully state that great care must be used in analyzing the report data, as reported results are derived from small, nonrandomized pilot trials, and therefore contain hidden biases. Even though the importance of CITR in managing islet transplant data and facilitate the integration of islet transplantation into diabetes care will strengthen over time, the results from its inaugural year are already vitally useful to transplant professionals, basic scientists, health care provides, funding agencies, tax payers, and of course, patients.

This article was authored by Jean-Philippe Cartailler, Ph.D.  Comments and/or questions about this article can be J.-P. Cartailler.

The Beta Cell Biology Consortium is dedicated to the advancement of discoveries in beta cell related research.

References

Close, N. C., B. J. Hering, R. Anand and T. L. Eggerman. "Collaborative Islet Transplant Registry." Clin Transpl: 109-18 (2003).

Close, N. C., B. J. Hering and T. L. Eggerman. "Results from the inaugural year of the collaborative islet transplant registry." Transplant Proc 37(2): 1305-8 (2005).

Matsumoto, S., O. Lawrence, T. H. Rigley, J. R. Lakey, R. B. Stevens and D. M. Strong. "University of wisconsin solution with trypsin inhibitor pefabloc improves survival of viable human and primate impure islets during storage." Cell Tissue Bank 2(1): 15-21 (2001).

Trotti, A., A. D. Colevas, A. Setser, V. Rusch, D. Jaques, V. Budach, C. Langer, B. Murphy, R. Cumberlin, C. N. Coleman and P. Rubin. "CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment." Semin Radiat Oncol 13(3): 176-81 (2003).