1. International Islet Transplant Registry (ITR) Newsletter #9, June 2001 Third Medical Department, University Hospital Giessen, Germany Mathias D. Brendel, Bernhard J. Hering, Andreas O. Schultz, Reinhard G. Bretzel

2. Longest Graft Function of Islet Allografts in Diabetes Mellitus graft functioninsulin independence IAK> 11 yrs 1 mo4 yrs 2 m SIK> 10 yrs 1 mo 5 yrs 10 m PIDM-Allo 4 yrs 8 m4 yrs 8 m PIDM-Auto > 13 yrs > 13 yrs

4. Summary of Adult Islet Autografts According to Institution and Year 1990 through December 31, 2000 2000 data on file incomplete

5. InstitutionsMinneapolis 54 Leicester 34 Geneva14 Indianapolis11 11 other Institutions27 No. of cases 140 Insulin-independent ≥ 7 days (1990-2000):41 / 64* (64%) Insulin-independent at ≥ 1 yr (1990-1999 + one year follow-up):27 / 57* (47%) if more than 300,000 IEQ transplanted:15 / 21* (71%) Longest insulin-independence follow-up after total pancreatectomy: > 13 yrs Islet Autografts from 1990 - 2000 2000 data on file incomplete * only well documented cases

6. Summary of Adult Islet Allografts According to Institution and Year - 1990 through December 31, 2000 2000 data on file incomplete

7. No. of Institutions Reporting Adult Islet Allografts in Patients with Diabetes by Year from 1974 through 2000 No. of Institutions by Year 2000 data on file incomplete 197419801985199019952000 11 2 4 222 11 4 222 5 9 11 12 14 15 11 8 12 15 0 5 10 15

8. No. of Adult Islet Allografts by Year No. of Adult Islet Allografts in Patients with Diabetes by Year from 1974 through 2000 2000 data on file incomplete 197419801985199019952000 9 1 10 11 3 2 6 4 14 2 4 2 12 37 26 25 28 29 59 44 38 22 34 51 0 10 20 30 40 50 60

9. Summary of Adult Islet Allografts in Type-1 Diabetic Recipients According to Institution and Year - 1990 through Dec. 31, 2000 2000 data on file incomplete

10. No. of cases:355 Institutions:Giessen66 Milan42 Minneapolis 35 Miami32 Pittsburgh26 Edmonton20 Geneva19 St. Louis14 29 additional institutions (≤ 10 cases)99 Insulin-independent ≥ 7 days (1990-2000): 52 / 281 (19%)* Insulin-independent at ≥ 1 yr (1990-1999 + one year follow-up):27 / 237 (11%)* Insulin-independent after 1:1 tx ≥ 7 days (1990-2000):21 / 151 (14%)* Insulin-independent after 1:1 tx at ≥ 1 yr (1990-1999+ one year follow-up):13 / 140 ( 9%)* Longest insulin-indepence follow-up: 70 months Adult Islet Allografts in Type-1 Diabetic Recipients 1990 - 2000 * only well documented cases

11. 169 108 133 34 76 23 EuropeNorth-America 0 50 100 150 200 Insulin Independence and Basal C-Peptide after Adult Islet Allotransplantation in 281 Type-1 Diabetic Recipients from 1990 - 2000 according to Continent total # of cases C-peptide ≥ 0.5 ng/mL at ≥ 1mo off insulin ≥ 1 week (79%)(20%)(70%)(21%) Four transplantations performed elsewhere

12. 140 97 95 18 78 20 single donormultiple donors 0 20 40 60 80 100 120 140 160 Insulin Independence and Basal C-Peptide One Year after Adult Islet Allotransplantationin 237* pre Tx C-Peptide negative Type-1 Diabetic Recipients from 1990 - 1999 according to Number of Donors total # of cases C-peptide ≥ 0.5 ng/mL at ≥ 1mo off insulin ≥ 1 week (68%)(13%)(80%)(21%) * Only well documented cases

13. 146 78 114 32 52 4 ≥ 6000 IEQ/kg BW< 6000 IEQ/kg BW 0 20 40 60 80 100 120 140 160 Insulin Independence and Basal C-Peptide One Year after Adult Islet Allotransplantation in 237* pre Tx C-Peptide negative Type-1 Diabetic Recipients from 1990 - 1999 according to Number of Islet Equivalents per kg Body Weight total # of cases C-peptide ≥ 0.5 ng/mL at ≥ 1mo off insulin ≥ 1 week (78%)(22%)(67%) no data available in 13 cases (5%) * Only well documented cases

14. 162 62 126 28 38 7 ≤ 8 hrs> 8 hrs 0 20 40 60 80 100 120 140 160 180 Insulin Independence and Basal C-Peptide One Year after Adult Islet Allotransplantation in 237* pre Tx C-Peptide negative Type-1 Diabetic Recipients from 1990 - 1999 according to Cold Ischemia Time no data available in 13 cases total # of cases C-peptide ≥ 0.5 ng/mL at ≥ 1mo off insulin ≥ 1 week (78%)(17%)(61%) (11%) * Only well documented cases

15. 131 87 7 9 3 101 14 59 23 5 0 5 1 3 0 SIKIAKSILITAothers 0 20 40 60 80 100 120 140 Insulin Independence and Basal C-Peptide One Year after Adult Islet Allotransplantation in 237* pre Tx C-Peptide negative Type-1 Diabetic Recipients from 1990 - 1999 according to Recipient Category total # of cases C-peptide ≥ 0.5 ng/mL at ≥ 1mo off insulin ≥ 1 week (68%)(77%)(11%)(26%) * Only well documented cases

16. 147 30 15 40 117 31 20 3 15 1 18 2 ATG/ALGOKT3Anti-IL-2R ABno T-cell AB 0 20 40 60 80 100 120 140 160 Insulin Independence and Basal C-Peptide after One Year Adult Islet Allotransplantation in 237* pre Tx C-Peptide negative Type-1 Diabetic Recipients from 1990 - 1999 according to Induction Immunosuppression total # of cases C-peptide ≥ 0.5 ng/mL at ≥ 1mo off insulin ≥ 1 week (80%)(21%)(67%) (10%) (45%) (5%) (100%) (7%) * Only well documented cases(Five additional cases with Anti-CD4 not depicted)

17. 67 170 58 21 115 17 all four≥ one not 0 20 40 60 80 100 120 140 160 180 Insulin Independence and Basal C-Peptide One Year after Adult Islet Allotransplantation in 237* pre Tx C-Peptide negative Type-1 Diabetic Recipients from 1990 - 1999 according to Common Criteria Common Criteria: a) IEQ/kg BW ≥ 6,000; b) CIT ≤ 8 hrs; c) ALG/ATG; d) Implantation Site: Liver (via portal vein) total # of cases C-peptide ≥ 0.5 ng/mL at ≥ 1mo off insulin ≥ 1 week (87%)(68%)(10%) * Only well documented cases (31%)

24. Type-1 Diabetic Recipients of Adult Islet Allografts (One Year Follow-Up) Insulin-Independent Cases (n=50) through December 31, 1999 S=Steroids, C=Cyclosporine, T=Tacrolimus, Si=Sirolimus, D=Deoxyspergualin, A=Azathioprin, MMF=Mycophenolate Mofetil, aIL2R=Anti IL-2 Rec Ab, CPM=Cyclophosphamide, NA=Not Available Insulin independence for ≥ 7 days at any time after I-Tx

25. (1)New website for the International Islet Transplant Registry at the University of Giessen, including the newest available version of the annual newsletter provided by the ITR, and valuable links to websites: http://www.med.uni-giessen.de/itr (2)Maintenance of the ITR will be supported by the JDFI for the coming five-year period Last but not Least

26. We would like to thank all of the collaborating institutions for their continued support of the Islet Transplant Registry