INTERNATIONAL ISLET TRANSPLANT REGISTRY In this Newsletter • Introduction, Editorial Board, Registry Staff and Address.............. 2 - 3 • New ITR-Forms .................................................................................... 4 - 7 • Results on all adult islet allografts through Dec 31, 1992 ............... 8 - 11 • Detailed analysis of the adult 1990-92 cases.................................... 12 - 19 • Listing of insulin independent adult islet allograft recipients......... 20 - 21 • Brief description of fetal grafts reported to the ITR.......................... 22 - 23 • Listing of participating institutions.................................................... 24 New ITR-Forms developed considering valuable proposals made by Dr. David Scharp, Washington University, St. Louis, in cooperation with other leading North American Islet Transplant Centers RECIPIENT FORM FOR CLINICAL I SLET TRANSPLANTS Liver Spleen Kidney Capsule Epiploic Flap Site of Tx ITR Institution # Case # Transplant Team Date of Tx Type of DM Type-I DM Date of Birth Age of Diabetes Onset Weight (kg) Sex male female 0 A B AB ABO 1 No. of Donors HLA: Local Code Transplant Center A B DR RECIPIENT DATA TRANSPLANT DATA INSTITUTION DATA First and Last Initial HLA of tx'd Kidney: positive negative CMV Induction IS Height (cm) Autograft Allograft Xenograft Species: Adult Fetal Donor Tissue Recipient Form for Clinical Islet Transplants Donor Form for Clinical Islet Transplants (Adult Tissue) Donor Form for Clinical Islet Transplants (Fetal Tissue) Follow-Up Form for Clinical Islet Transplants
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INTERNATIONAL ISLET TRANSPLANT REGISTRY · OK T3 Height (cm) 1st 2nd Autograft Allograft Xenograft Species: Adult Fetal Donor Tissue ITR-R-93-1. International ISLET TRANSPLANT REGISTRY
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INTERNATIONAL ISLETTRANSPLANT
REGISTRY
In this Newsletter• Introduction, Editorial Board, Registry Staff and Address.............. 2 - 3• New ITR-Forms .................................................................................... 4 - 7• Results on all adult islet allografts through Dec 31, 1992 ............... 8 - 11• Detailed analysis of the adult 1990-92 cases.................................... 12 - 19• Listing of insulin independent adult islet allograft recipients......... 20 - 21• Brief description of fetal grafts reported to the ITR.......................... 22 - 23• Listing of participating institutions.................................................... 24
New ITR-Forms developed
considering
valuable proposals
made by Dr. David Scharp,
Washington University, St. Louis,
in cooperation with other leading
North American Islet Transplant Centers
RECIPIENT FORM FOR CLINICAL ISLET TRANSPLANTS
LiverSpleenKidney CapsuleEpiploic Flap
Site of Tx
ITR Institution #
Case #
Transplant Team
Date of Tx Type of DMType-I DM
Date of Birth
Age of Diabetes Onset
Weight (kg)
Sex malefemale
0A
BAB
ABO
1No. of Donors
HLA:
Local Code
Transplant Center
A B DR
RECIPIENT DATA
TRANSPLANT DATA
INSTITUTION DATA
First and Last Initial
HLA of tx'd Kidney:
positivenegative
CMV
Induction IS
Height (cm)
AutograftAllograftXenograftSpecies:
AdultFetal
Donor Tissue
• Recipient Form for Clinical Islet Transplants
• Donor Form for Clinical Islet Transplants (Adult Tissue)
• Donor Form for Clinical Islet Transplants (Fetal Tissue)
• Follow-Up Form for Clinical Islet Transplants
D ear Islet Transplant Registry Participant,
we are pleased to present the IsletTransplant Registry Newsletter No. 4on the occasion of the 4th Internatio-nal Congress on Pancreas and IsletTransplantation in Amsterdam, June27-30, 1993. We would like to expressour gratitude to the Chairman of thisC o n g ress, Dr. Reinout van Schilf-gaarde, for offering the possibility tohand over a personal copy to eachcongress participant. In addition, wewould also like to thank you for yourcontinuous support and efforts in pro-viding us with data on your patients.
This Newsletter includes re v i s e dRegistry Forms, results of an analysison all adult islet allografts performedworldwide through Dec 31, 1992, withmain emphasis on the period fro m1990-92 as well as a brief descriptionof fetal islet grafts reported to the Regi-stry.
The significant progress of the lastyears culminating in prolonged insu-lin independence following islet allot-ransplantation in diff e rent re c i p i e n tcategories and at diff e rent instituti-ons made us expecting a rapid deve-lopment in the field of clinical islettransplantation. It is true that furthercenters reached insulin independenceafter islet transplantation but theexpected bre a k t h rough on a widefront failed to come. At present, onlyfive patients are insulin independentafter islet allotransplantation, thre etype 1 diabetic patients (two in Milan,one in Minneapolis) as well as twopatients with pancre a t e c t o m y - i n d u-ced diabetes mellitus (one patient inP i t t s b u rgh and one patient in Milan).The number of transplantations peryear decreased from 36 in 1990 to 26in 1991 and 23 in 1992. In the first sixmonths of 1993 only eight transplan-tations are known to be performed(four in Giessen, two in Milan, one inMinneapolis and another one in LosAngeles). More o v e r, the results in islettransplantation could not be signifi-cantly improved since 1990. Another
step forward is of crucial importancefor islet transplantation and for allinstitutions involved to keep clinicaland scientific programs ru n n i n g .
Which future directions are pro-mising enough to be taken? Fre-quently mentioned approaches arecollagenase, pre-transplant isletimmunomodulation and new immu-n o s u p p ressive agents etc. However,it is only through a careful analysis ofdata that the impact of these or othera p p roaches can be substantiated.
In this respect, the Islet TransplantRegistry can contribute to advance thep ro g ress. As the number of trans-planted cases per center is low, it isevident that trends or even conclusi-ons can emerge much earlier whenall results achieved worldwide arecollected and then subjected to scien-tific analysis. The Registry can onlyfulfill this task if the forms will becompleted more thoroughly and con-scientious in the future. The accuracyof the Registry´s results depends verymuch on the quality of data that youprovide and can only be guaranteedby truthful reporting of successes andfailures.
We have always realized that com-pleting the previous Registry Formswas cumbersome and time consu-ming for you. Thus, these formsunderwent major revisions in ord e rto achieve more clearness by consi-dering only the very essential items.In this respect, we very much appre-ciated the recommendations pro v i-ded by Dr. David W. Scharp,Washington University, St. Louis andcolleagues of other leading NorthAmerican Islet Transplant Centers.
We are confident that completion ofthe Forms as well as data entry willnow be simplified and accelerated. Asubstantial advantage of the newForms is that print-outs of data onceput into the data base can be genera-ted directly onto these Forms. Thisguarantees a habitual format; proof-reading and updating of the data canbe done much more efficient on a
single form. Disks with File MakerPro 2.0 - files for direct data entry ona Macintosh computer are availableon request.
Standardized and accepted criteriafor the assessment of islet preparati-ons and for patient monitoring posttransplant are urgently re q u i red. Afirst step was the definition of isletequivalents and of the Sustacal sti-mulation index by Dr. David W.Scharp. In particular, assessment ofviability and function of human isletsp retransplant should be standard i-zed. We have to face loss of islet graftfunction in about 30% of cases withinthe first month and it will there f o rebe important to determine whetherthese early graft failures are a re s u l tof grafting an insufficient number ofviable islet equivalents. Many centersalready use similar methods for isletassessment, however, a large numberof unnecessary modifications existpreventing meaningful comparisonsof results between different instituti-ons.
During the Fourth InternationalC o n g ress on Pancreas and Islet Tr a n s-plantation a Workshop chaired by Dr.R e i n h a rd G. Bretzel, University ofGiessen, and Dr. Camillo Ricordi, Uni-versity of Pittsburgh, will try againto elaborate improvements in this cru-cial field. It is to be hoped that thisWorkshop will manage to define gui-delines for islet graft assessment andpatient monitoring and that everygroup performing clinical islet trans-plantation will adhere to these gui-delines in the future, eventually incarefully designed multicenter trials.
Again, we thank for your coopera-tion and participation in the IsletTransplant Registry.
Giessen, June 1993
Bernhard J. HeringChristian C. BrowatzkiAndreas O. SchultzBarbara WatzReinhard G. BretzelKonrad Federlin
Justus-Liebig-University of GiessenDepartment of Medicine
The Islet Transplant Registry Newsletter is publishedregularly and distributed to all interested institutions.It is anticipated that the fith newsletter will be issuedtowards the end of 1993.
Konrad Federlin, MDProfessor of Medicine
Reinhard G. Bretzel, MDProfessor of Medicine
Bernhard J. Hering, MD
Professor Konrad Federlin, MDDirector
Professor Reinhard G. Bretzel, MDVice-Director
Bernhard J. Hering, MDRegistry Coordinator
Christian C. Browatzki, MDRegistry Vice-Coordinator
Andreas O. SchultzRegistry Administrator & Programmer
Barbara WatzCorrespondent
Professor David E.R. Sutherland, MD, PhDDirector, International Pancreas Transplant Registry
Kay C. Moudry-Munns, RNC, CCRN, BSNCoordinator, International Pancreas Transplant Registry
Islet-Transplant-RegistryContact: Bernhard J. Hering, MDDepartment of MedicineJustus-Liebig-University of GiessenRodthohl 6D-35392 GiessenGermanyPhone: (49)-641-702-7445Fax: (49)-641-702-7443
International
RECIPIENT FORM FOR CLINICAL ISLET TRANSPLANTS
Director: Professor Konrad Federlin, M.D.Medizinische Klinik III & Poliklinik der Justus-Liebig-Universität
One-Year Islet Allograft Survival byYear of Transplant (1990 - 92)
The 1990-92 Period
In the 1990-92 period a total number of 85adult allotransplants were reported to theIslet Transplant Registry worldwide. Forthe analysis three patients had to be exclu-ded since provided data were far fro mbeing complete. Another six patients hadto be excluded due to clearly positive pre-transplant basal C-peptide levels (≥ 0.4 ng/ml). The pretransplant basal C-peptide levels of the remaining patientswere 0, < 0.1, < 0.2 and < 0.4 ng/ml in 19,34, 13 and 10 cases, re s p e c t i v e l y. Thus 76patients were taken into the analysis andthe results are depicted in bar charts onpages 13-19.In addition, adult islet allograft survival asassessed by basal C-peptide ≥ 1ng/ml overthe first year posttransplant in re g a rd toyear of transplantation, number of donorsetc. are illustrated on pages 12-19.Fifty-three patients have been included inthese survival charts , all of whom had com-plete 1-year follow-up data (for this re a-son, patients transplanted in the secondhalf of 1992 were not considered).
1 2 3 4
Insulin Independence and Basal C-Peptide according toNo. of Donors (1990 - 92)
No. of Donors
total # of cases C-peptide 1ng/ml 1mo off insulin > 1 week38
15
11 12
21
6
14
69
46
2
0
5
10
15
20
25
30
35
40
B
B
B
B
B
B
J
J
J
J
J
J
É
É
É
É
É
É
Ç
Ç
Ç Ç
Ç Ç
0 1 2 3 4 5 6 7 8 9 10 11 120
10
20
30
40
50
60
70
80
90
100
% g
raft
su
rviv
al (
bas
al C
-pep
tid
e
1n
g/m
l)
month post tx
B 1 donor (n = 24)
J 2 donors (n = 12)
É 3 donors (n = 9)
Ç 4 donors (n = 8)
One-Year Islet Allograft Survival according toNo. of Donors (1990 - 92)
Insulin Independence and Basal C-Peptide according toEquivalent Number of Islets (IEQ) (1990 - 92)
IEQ
total # of cases C-peptide 1ng/ml 1mo off insulin > 1 week
36
26
14
20
5
21
10 9
3
< 500,000 500,000 - 1,000,000 > 1,000,0000
5
10
15
20
25
30
35
40
B
B
B
B
B
É
É
É É
É
É
É
Ç
Ç
Ç
Ç
Ç
Ç
0 1 2 3 4 5 6 7 8 9 10 11 120
10
20
30
40
50
60
70
80
90
100
% g
raft
su
rviv
al (
bas
al C
-pep
tid
e
1n
g/m
l)
month post tx
B < 500,000 (n = 24)
É < 1,000,000 (n = 18)
Ç > 1,000,000 (n = 11)
One-Year Islet Allograft Survival according toEquivalent Number of Islets (1990 - 92)
Insulin Independence and Basal C-Peptide according toCold Ischemia Time * (1990 - 92)
total # of cases C-peptide 1ng/ml 1mo off insulin > 1 week
27
40
4 5
20
9
27
9
2 1
< 6 h 6 - 12 h > 12 h data incomplete0
5
10
15
20
25
30
35
40
* in case of multiple donors mean cold ischemia time was calculated
Insulin Independence and Basal C-Peptide according toPurity of Islet Tissue (1990 - 92)
total # of cases C-peptide 1ng/ml 1mo off insulin > 1 week
68
8
45
16
52
purified tissue digested tissue0
10
20
30
40
50
60
70
Insulin Independence and Basal C-Peptide according toPreservation of Islet Tissue (1990 - 92)
total # of cases C-peptide 1ng/ml 1mo off insulin > 1 week
55
11
5 5
39
14
74
2 2
fresh/culture fresh/culture & cryo cryo only not reported0
10
20
30
40
50
60
Insulin Independence and Basal C-Peptide according toSite of Tx (1990 - 92)
total # of cases C-peptide 1ng/ml 1mo off insulin > 1 week
Genova 1979 ITA s.c. 3rd - 10th month C-peptide data not available
Genova 1979 ITA s.c. 3rd - 19th month C-peptide data not available
Summary of Cases reported to be Off Insulinafter Adult Islet Tissue Transplantation
without detailed information
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pretransplant 1 year posttransplant4
5
6
7
8
9
10
11
12
Hb
A1c
(%
)
Basal C-Peptide 1ng/ml at 1 Year (n= 9)
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pretransplant 1 year posttransplant4
5
6
7
8
9
10
11
12
Hb
A1c
(%
)
Basal C-Peptide < 1ng/ml at 1 Year (n=12)
Glycated Hemoglobin (HbA1c-levels) before and One Year after Adult Islet Allotransplantation according to Basal C-Peptide Levels
Insulin Independence after Adult Islet Transplantation in Type I Diabetes
Summary of cases through Dec 31, 1992
* IEQ: eqivalent no. of islets (number of islets if all were 150 micrometers in diameter)IAK: islet after kidney (islet transplantation in patients with established kidney grafts) 1 since then 4-8 U insulin per daySIK: simultaneous islet and kidney transplantation 2 as of June 11, 1993
† in the early posttransplant period 3 as of May 18, 1993
Year No. of Donors Site Type HLA match Induction Period of Insulin GlucoseInstitutionof Tx Fresh Cryo IEQ* 1000 of Tx of Tx AB DR Immunosuppression Independence post tx Control†
St. Louis 1989 1.4 - 785 p.v. IAK* 1/3 2/1 ALG (+M-Pred) 10th - 25th day IV InsulinSt. Louis 1990 1 + 2 550 + 555 p.v. IAK* 1/2/2 1/1/0 ALG (+M-Pred) 33rd - 341st day IV Insulin
Edmonton1990 1 + 4 243 + 368 p.v. SIK* 3 0 (fresh) ALG (+M-Pred, AZA, 69th - 821st day IV Insulin 1/0/2/0 0 (cryo) CsA at day 10)
Edmonton1992 1 + 5 284 + 308 p.v. SIK* 3 1 (fresh) ALG (+M-Pred, AZA, 155th - 166th day1 IV Insulin1/0/0/1/0 1/1/0/0/1 (cryo) CsA at day 8)
Summary of Fetal Islet Grafts Reported to the Registry
according to Institution and Year through Dec 31, 1992
• Genova 79 - 80 13
• Shanghai 81 - 88 75
• Stockholm 82 - 84 3
• Szeged 82 - 92 25
• Melbourne 83 - 86 8
• Sydney 83 - 86 5
• Albany 85 1
• Dallas 85 6
• Denver 85 - 87 16
• Moscow 88 - 91 25
INSTITUTION YEAR OF TX CASES
TOTAL NO. OF CASES: 177TOTAL NO. OF INSTITUTIONS: 25
Fetal Islet GraftsAccording to the data reported in the literature or com-municated to the scientific community, fetal islet tissuehas been transplanted to approximately 2,000 diabeticrecipients (see Newsletter No. 1). In this Newsletter, re s u l t son the 177 grafts only, which have been reported to theRegistry are presented. These reports are very muchappreciated since they facilitate to start with the evalua-tion of the potential impact of fetal islet tissue trans-plantation. The first two figures are a breakdown of 177 fetal isletgrafts according to the number of fetal donor pancreataand according to the recipient category, re s p e c t i v e l y. Thelast two pairs of figures compare the highest basal C-peptide levels and the lowest insulin re q u i rements within the first year following fetal and adult islet tissuetransplantation.Similar to the exclusion criteria of the 1990-92 period,only cases holding pre- as well as posttransplant dataw e re considered, resulting in only 66 fetal cases with pre -and posttransplant C-peptide data. It is interesting thata reduction of insulin re q u i rement appeared in both adultand fetal islet transplant recipients, although posttrans-plant basal C-peptide levels ≥ 1 ng/ml were frequentlyreported in the adult islet transplant group but not in asingle case in the fetal islet transplant group. In the thre efetal islet transplants, which were reported to be insulinindependent, no pretransplant C-peptide levels weregiven and the basal C-peptide levels within one year werein the range of 0.6 and 0.9 ng/ml.
140
18 154
ITA IAK SIK not reported0
20
40
60
80
100
120
140
Reported Fetal Islet Transplants according to Recipient Category (1979 - 91)
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pretransplant 1 year posttransplant0
10
2030
40
5060
70
8090
100
Dai
ly in
sulin
req
uir
emen
t (U
)
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pretransplant 1 year posttransplant0
10
20
30
40
50
60
70
80
90
100
Dai
ly in
sulin
req
uir
emen
t (U
)
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pretransplant 1 year posttransplant0
1
2
3
4
5
6
7
Bas
al C
-pep
tid
e (n
g/m
l)
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pretransplant 1 year posttransplant0
1
2
3
4
5
6
7
Bas
al C
-pep
tid
e (n
g/m
l)
Islet Transplant Success in Terms of Lowest Daily Insulin Requirementand Highest Basal C-Peptide within one Year Posttransplant
Abri O 1st Dept. of SurgeryKrankenhaus MoabitD-1000 Berlin 21, GERMANYPhone: (49)-30-3937-1
Alejandro R & Mintz DHDiabetes Research Institute (R-134)Univ. of Miami School of MedicineMiami, FL 33101, USAPhone: (1)-305-547-6657Fax: (1)-305-548-4404
Atkinson P (in coop. with St. Louis)Multiorgan Transplant ServiceUniversity HospitalLondon, Ontario N6A 5A5, CANADAPhone: (1)-519-663-3179Fax: (1)-519-663-3858
Calafiore R & Brunetti PIstituto di Patologia Speciale MedicaUniversity of PerugiaI-06100 Perugia, ITALYPhone: (39)-75-21366Fax: (39)-75-469-2067
Cerilli GJDept. of SurgeryAlbany Medical CollegeAlbany, NY 12208, USA
Coulic V Faculty of MedicineUniv. of People’s Friendship P. LumumbaMoscow 117198, RUSSIA
Dawidson I & Raskin PDept. of SurgeryUniversity of Texas at DallasDallas, TX 75235, USA
Farkas G Dept. of SurgeryA. Szent-Györgyi Medical UniversityH-6701 Szeged, HUNGARYPhone: (36)-62-22-444
Faustman DL Massachusetts General Hospital EASTHarvard Medical SchoolCharlestown, MA 02129, USAPhone: (1)-617-726-4080Fax: (1)-617-726-4095
Gores PF & Sutherland DER Dept. of SurgeryUniversity of MinnesotaMinneapolis, MN 55455, USAPhone: (1)-612-626-2101Fax: (1)-612-625-4453
Gray DWR & Morris P Nuffield Dept. of SurgeryUniversity of OxfordHeadington, Oxford OX3 OEX, UKPhone: (44)-865-22-6092Fax: (44)-865-22-5773
Groth CG Dept. of Transplantation SurgeryKarolinska Institute StockholmS-141 86 Huddinge, SWEDENPhone: (46)-8-746-1000Fax: (46)-8-746-7733
Hering BJ, Bretzel RG & Federlin K 3 rd Dept. of MedicineUniversity of GiessenD-35392 Giessen, GERMANYPhone: (49)-641-702-7445Fax: (49)-641-702-7443
Hu Y-FDiabetes Research LaboratoryShanghai First People’s HospitalShanghai 200085, PR of CHINA
Kühn F, Lorenz D, Lippert H & Wolff HDept. of SurgeryHumboldt University (Charité)D-1040 Berlin, GERMANYPhone: (49)-30-2802-3881Fax: (49)-30-2802-1323
Largiadèr FDept. of Surgery AUniversity of ZurichCH-8091 Zurich, SWITZERLANDPhone: (41)-1-255-1111Fax: (41)-1-255-4442
London NJM, James RFL & Bell PRF Dept. of SurgeryUniv. of Leicester School of MedicineLeicester LE2 7LX, UKPhone: (44)-533-523-142Fax: (44)-533-523-179
Mandel TEWalter & Eliza Hall Inst. of Med. Res.University of MelbourneParkville, Victoria 3050, AUSTRALIAPhone: (61)-3-345-2555Fax: (61)-3-347-0652
Mullen Y, Watt PC & Brunicardi FCDiabetes Research CenterUniv. of California at Los AngelesLos Angeles, CA 90024-7036, USAPhone: (1)-310-825-4359Fax: (1)-310-794-7173
Pichlmayr R & Rumpf KDDept. of Abd. and Transplant SurgeryMedical School of HannoverD-3000 Hannover 61, GERMANYPhone: (49)-511-532-3440Fax: (49)-511-556747
Ricordi C, Carroll P, Tzakis A & Starzl TDept. of SurgeryUniversity of PittsburghPittsburgh, PA 15261, USAPhone: (1)-412-624-4616Fax: (1)-412-624-6666
Scharp DW, Flavin K & Lacy PE Islet Transplant CenterWashington Univ. School of MedicineSt. Louis, MO 63110, USAPhone: (1)-314-362-8320Fax: (1)-314-361-0426
Socci C, Maffi P, Di Carlo V & Pozza GDiv. di Medicina I et Chirurgica II Ospedale San RaffaeleI-20129 Milano, ITALYPhone: (39)-2-2643-2323Fax: (39)-2-2643-2482
Spees E & Lafferty KJ A.M.I. St. Luke’s HospitalUniversity of ColoradoDenver, CO 80262, USA
Toledo-Pereyra LDept. of SurgeryMt. Carmel Mercy HospitalDetroit, MI 48235, USA
Tuch BDept. of Endocrinology & MetabolismThe Prince of Wales HospitalSydney, N.S.W. 2031, AUSTRALIAPhone: (61)-2-399-1828Fax: (61)-2-398-9887
Urca I Dept. of SurgeryBeilinson HospitalPetah Tikva, ISRAEL
Valente UTransplant UnitUniversita di GenovaI-16132 Genova, ITALY
Warnock GL, Lakey JRT & Rajotte RVSurgical-Medical Research InstituteUniversity of AlbertaEdmonton T6G 2N8, CANADAPhone: (1)-403-492-4595Fax: (1)-403-492-1627
Acknowledgementshis Newsletter reflects the collaborative efforts of the followingenters engaged in clinical transplantation of adult and fetalslets. Their support to the Registry is gratefully acknowledged.
The asterix indicates the centers that have sent report forms tohe International Pancreas and Islet Transplant Registry in
Minneapolis in former years. When the responsibility for theslet component was transferred to Giessen, these forms wereraciously passed on to the Islet Transplant Registry by Dr. David