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CITR Annual Report Exhibits2007 CITR Annual ReportExhibits
Prepared by:
CITR Coordinating CenterThe EMMES Corporation
Rockville, MD
Sponsored by:National Institute of Diabetes & Digestive & Kidney Diseases
National Institutes of HealthBethesda, MD
Datafile Closure: April 1, 2007
Table of Contents
Chapter 1: Islet Transplant Activity
Chapter 2: Recipient and Donor Characteristics
Chapter 3: Pancreas Procurement, Islet Processing and Infusion
Characteristics
Chapter 4: Immunosuppression and Other Medications
Chapter 5: Graft Function
Chapter 6: Liver, Kidney, Lipid and PRA Effects
Chapter 7: Adverse Events
Chapter 8: Registry Data Quality Review
CITR Coordinating Center
CITR Committees
Chapter 1: Islet Transplant Activity
Islet Transplant Centers Reporting Data to CITR:Participating North American Centers 1999-2006
A - CITR Centers with at least one islet allograft infusion procedure conducted in 2006C - CITR Centers with no islet allograft infusions in 2006D - CITR Coordinating Center
Number of Islet Transplantation Centers Performing Islet Allografts per Year
and Number with Data Entered in CITR Database All North American Islet Transplant Centers 1999-2006
All North American Centers Performing Islet Allografts (N=31)CITR-Participating Centers with Data Entered (N=24)
6
3
9
6
16
11
14
10
20
15
23
1716
14
Num
ber o
f Cen
ters
0
5
10
15
20
25
1999-2000 2001 2002 2003 2004 2005 2006
Total Number of Islet Transplant Recipients, Recipients at CITR-Participating Centers,
and Recipients with Detailed Data Reported to CITR By Year of First Islet Allograft Infusion
All North American Islet Transplant Centers 1999-2006
The Islet Transplant Summary (ITS) questionnaire is completed by all North American Islet Transplant Programs regardless of their participation in the Registry. Of 45 North American islet transplant programs polled, all have provided this information through 2006.
All North American Recipients (N=356)All North American CITR Recipients (N=315)Recipients with Detailed Data Reported to CITR (N=268)
31 31
16
45 44
35
82
75
69
45
3835
53
4240
64
54
44
3631
29Num
ber
of R
ecip
ients
0
10
20
30
40
50
60
70
80
90
1999-2000 2001 2002 2003 2004 2005 2006
Total Number of Islet Allograft Infusion Procedures Performed and Number with Data Reported to CITR:
CITR-Participating North American Islet Transplant Centers 1999-2006
All Infusions for North American Recipients (N=675)All Infusions for North American CITR Recipients (N=596)Infusions with Data Reported to CITR (N=512)
50 50
32
65 64
49
142
132
119
106
9183
110
8985
124
106
88
78
6456
Num
ber
of P
roce
dure
s
0
20
40
60
80
100
120
140
160
1999-2000 2001 2002 2003 2004 2005 2006
Total Number (N=579) of Islet Allograft Infusion Procedures Conducted and Entered in CITR Database, by Year and Infusion Procedure Number:
CITR-Participating North American and International Centers, 1999-2006
First infusionSecond InfusionThird InfusionFourth Infusion
38
49
119
9298
107
71
5
Num
ber
of Is
let I
nfus
ions
0
15
30
45
60
75
90
105
120
1999-2000 2001 2002 2003 2004 2005 2006 2007
Total Number (N=579) of Islet Allograft Infusion Procedures Per Recipient:
CITR-Participating North American and International Centers, 1999-2006
76
149
63
4
Num
ber
of R
ecip
ient
s
0
20
40
60
80
100
120
140
160
Total Number of Infusions Received
1 2 3 4
Islet Alone and Islet After Kidney Recipients:CITR-Participating North American and International Centers,
1999-2006
SUM of value by type
Islet Alone262
Islet After Kidney30
Chapter 2: Recipient and Donor Characteristics
Recipient Demographics
Transplant Recipient Primary Funding InformationCITR-Participating US Centers
Recipient Characteristics at First Infusion
Recipient Diabetes Characteristics at First Infusion
Recipient Diabetes Characteristics at First Infusion (continued)
Recipient Infectious Disease Testing at First Infusion
Recipient Characteristics at First Infusion by Total Number of Infusions Received
Recipient Demographics and Characteristics at First Infusionby Total Number of Infusions Received
Recipient Laboratory Values at First Infusion
Donor DemographicsAll Allograft Donors
Donor CharacteristicsAll Allograft Donors
Donor CharacteristicsAll Allograft Donors (continued)
Characteristics of Organ Procurement and Donor Cause of DeathAll Allograft Donors
Treatments Given to Donor During HospitalizationAll Allograft Donors
Treatments Given to Donor During HospitalizationAll Allograft Donors (continued)
Donor SerologyAll Allograft Donors
Donor Laboratory DataAll Allograft Donors
Organ Crossmatch ResultsAll Allograft Donors
Chapter 3: Pancreas Procurement, Islet Processing and Infusion Characteristics
Pancreas Procurement and Islet Processing
Pancreas Procurement and Islet Processing (continued)
Pancreas Procurement and Islet Processing (continued)
Cold Ischemia Information
Islet Equivalents and Timing of Count
Islet Product Characterization
Islet Characteristics by Pancreas Preservation Method
Correlation of Islet Characteristics with Donor, Recovery, and Processing Characteristics
Islet Product and Infusion Characteristics by Infusion Sequence
Mean Number of Islet Equivalents/Kg Recipient by Total Number of Infusions Received
Pre Infusion Portal Pressure by Infusion Sequence
233 167 45
1 2 3
0
5
10
15
20
25
30
mm
Hg
Infusion Sequence
Peak Portal Pressure by Infusion Sequence
223 165 45
1 2 3
0
5
10
15
20
25
30
mm
Hg
Infusion Sequence
Closure Portal Pressure by Infusion Sequence
228 165 46
1 2 3
0
5
10
15
20
25
30
mm
Hg
Infusion Sequence
Change from Pre Infusion to Closure Portal Pressure by Infusion Sequence
226 164 45
1 2 3
-10
-5
0
5
10
15
20
mm
Hg
Infusion Sequence
Change from Pre Infusion to Peak Portal Pressure by Infusion Sequence
223 164 44
1 2 3
-10
-5
0
5
10
15
20
mm
Hg
Infusion Sequence
Cell Volume Infused per Infusion by Infusion Year
14 23 47 109 85 83 97 62
1999 2000 2001 2002 2003 2004 2005 2006
0.0
2.0
4.0
6.0
8.0
10.0
12.0
14.0
16.0
Cell
Volu
me (
mL)
Infusion Year
Chapter 4: Immunosuppression and Other Medications
Immunosuppression Regimen at Time of First Infusion
Immunosuppression Regimen at Time of First Infusion (continued)
T Cell Antibodies Used During First Infusion for Induction Therapy
Anti-inflammatory Therapy at Time of Infusion by Infusion Sequence
Immunosuppression Dosing (mg/day) at Time of Infusion by Infusion Sequence
Immunosuppression Therapy Use Post Last Infusion
Immunosuppression Therapy Use Post Last Infusion (continued)
Immunosuppression Dosing Post Last Infusion
Immunosuppression Dosing Post Last Infusion (continued)
Sirolimus Trough Level (ng/mL) Post Last InfusionAll Allograft Recipients
225 171 48 157 124 70 43
Inf 1Day 30
Inf 2Day 30
Inf 3Day 30
Month 6 Year 1 Year 2 Year 3
0.00
10.00
20.00
30.00
40.00
50.00
Siro
limus
Tro
ugh
(ng/
mL)
Follow -Up
*Value of 61.8 ng/mL at Inf 3 Day 30 excluded from display.
Verified correct by center, attributed to the participant taking Sirolimus shortly before sampling.
Tacrolimus Trough Level (ng/mL) Post Last InfusionAll Allograft Recipients
228 174 52 164 137 85 52
Inf 1Day 30
Inf 2Day 30
Inf 3Day 30
Month 6 Year 1 Year 2 Year 3
0.00
5.00
10.00
15.00
20.00
Tac
rolim
us T
roug
h (n
g/m
L)
Follow -Up
Anti-Hypertensive Medications Pre Infusion and Post Last Infusion
All Allograft Recipients
Total Number of Anti-Hypertensive Medications Pre Infusion and Post Last Infusion
All Allograft Recipients
Total Number of Medications 4321
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
Pre Infusion 1 Month 6 Year 1 Year 2 Year 3
Lipid Lowering Medications Pre Infusion and Post Last Infusion
All Allograft Recipients
Total Number of Lipid Lowering MedicationsPre Infusion and Post Last Infusion
All Allograft Recipients
Total Number of Medications 21
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
Pre Infusion 1 Month 6 Year 1 Year 2 Year 3
Adjunctive Therapy Used at Time of First InfusionAll Allograft Recipients
Vitamins
Rosiglitizone
Pioglitazone
Pentoxifyll ine
Pantoprazole
Ondansetron Hydrochloride
Nicotinamide
Metformin
Iron Supplements
Enoxaparin
Aspirin
Antivirals
Antifungals
Antibiotics
Percent of Recipients
0 10 20 30 40 50 60 70 80 90 100
Adjunctive Therapy Post Last InfusionAll Allograft Recipients
Chapter 5: Graft Function
Insulin Independence, Insulin Dependence, Absence of Fasting C-peptide, or Re-Infusion
Post First InfusionA. Islet Alone Recipients
Recipient Status Re-Infused Prior to Follow-UpInsulin IndependentInsulin Dependent with Detectable Fasting C-peptideNo Detectable Fasting C-peptideMissing Data
Perc
ent of R
ecip
ients
0
10
20
30
40
50
60
70
80
Day 30N=262
Day 75*N=262
Month 6N=255
Year 1N=244
Year 3**N=152
*C-peptide data not available at Day 75
**Year 3 status independent of re-infusion
Insulin Independence, Insulin Dependence, Absence of Fasting C-peptide, or Re-Infusion
Post First Infusion B. Islet After Kidney Recipients
Recipient Status Re-Infused Prior to Follow-UpInsulin IndependentInsulin Dependent with Detectable Fasting C-peptideNo Detectable Fasting C-peptideMissing Data
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
Day 30N=30
Day 75*N=30
Month 6N=29
Year 1N=26
Year 3**N=20
*C-peptide data not available at Day 75
**Year 3 status independent of re-infusion
Insulin Independence, Insulin Dependence or Absence of Fasting C-peptide
Post Last Infusion A. Islet Alone Recipients
Recipient Status Insulin IndependentInsulin Dependent with Detectable Fasting C-peptideNo Detectable Fasting C-peptideMissing Data
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
Month 6N=249
Year 1N=225
Year 2N=169
Year 3N=129
Insulin Independence, Insulin Dependence or Absence of Fasting C-peptide
Post Last InfusionB. Islet After Kidney Recipients
Recipient Status Insulin IndependentInsulin Dependent with Detectable Fasting C-peptideNo Detectable Fasting C-peptideMissing Data
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
Month 6N=28
Year 1N=25
Year 2N=23
Year 3N=11
Insulin Independence, Insulin Dependence, or Absence of Fasting C-peptide
Post Last Infusion by Total Number of Infusions ReceivedIslet Alone Recipients
A. Recipients of 1 Infusion
Recipient Status Insulin IndependentInsulin Dependent with Detectable Fasting C-peptideNo Detectable Fasting C-peptideMissing Data
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
Month 6N=63
Year 1N=56
Year 2N=39
Year 3N=33
Insulin Independence, Insulin Dependence, or Absence of Fasting C-peptide
Post Last Infusion by Total Number of Infusions ReceivedIslet Alone Recipients
A. Recipients of 2 Infusions
Recipient Status Insulin IndependentInsulin Dependent with Detectable Fasting C-peptideNo Detectable Fasting C-peptideMissing Data
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
Month 6N=129
Year 1N=117
Year 2N=88
Year 3N=66
Insulin Independence, Insulin Dependence, or Absence of Fasting C-peptide
Post Last Infusion by Total Number of Infusions ReceivedIslet Alone Recipients
A. Recipients of 3 Infusions
Recipient Status Insulin IndependentInsulin Dependent with Detectable Fasting C-peptideNo Detectable Fasting C-peptideMissing Data
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
Month 6N=57
Year 1N=52
Year 2N=42
Year 3N=30
Prevalence of Insulin Independence Post Last InfusionIslet Alone Recipients
Best Case Reported Worst Case
Perc
ent In
sulin
Independent
0
10
20
30
40
50
60
70
Days Post Last Infusion
0 100 200 300 400 500 600 700 800 900 1000 1100
Prevalence of Insulin Independence Post Last Infusion By Total Number of Infusions Received
Islet Alone Recipients
Total Number of Infusions Received One Two Three
Perc
ent In
sulin
Independent
0
10
20
30
40
50
60
70
Days Post Last Infusion
0 100 200 300 400 500 600 700 800 900 1000 1100
HbA1C A. Post First Infusion (Censored at Re-Infusion before Visit)
Islet Alone Recipients
HbA1c < 6.5%6.5% <= HbA1c < 7.0%HbA1c >= 7.0%Missing data for recipient without islet graft functionMissing data for recipient with islet graft function
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
Pre Inf 1N=262
Month 6N=110
Year 1N=76
HbA1C Post First Infusion (Censored at Re-Infusion before Visit)
Islet After Kidney Recipients
HbA1c < 6.5%6.5% <= HbA1c < 7.0%HbA1c >= 7.0%Missing data for recipient without islet graft functionMissing data for recipient with islet graft function
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
Pre Inf 1N=30
Month 6N=12
Year 1N=7
HbA1C
B. Post Last InfusionIslet Alone Recipients
HbA1c < 6.5%6.5% <= HbA1c < 7.0%HbA1c >= 7.0%Missing data for recipient without islet graft functionMissing data for recipient with islet graft function
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
Pre Inf 1N=262
Month 6N=249
Year 1N=225
Year 2N=169
Year 3N=129
HbA1C
B. Post Last InfusionIslet After Kidney Recipients
HbA1c < 6.5%6.5% <= HbA1c < 7.0%HbA1c >= 7.0%Missing data for recipient without islet graft functionMissing data for recipient with islet graft function
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
Pre Inf 1N=30
Month 6N=28
Year 1N=25
Year 2N=23
Year 3N=11
C-peptide 0.5 ng/mLA. Post First Infusion (Censored at Re-Infusion before Visit)
Islet Alone Recipients
C-peptide < 0.5 ng/mLC-peptide >= 0.5 ng/mLMissing data
Perc
ent of R
ecip
ients
0
10
20
30
40
50
60
70
80
90
Pre Inf 1N=262
Month 6N=110
Year 1N=76
C-peptide 0.5 ng/mLA. Post First Infusion (Censored at Re-Infusion before Visit)
Islet After Kidney Recipients
C-peptide < 0.5 ng/mLC-peptide >= 0.5 ng/mLMissing data
Perc
ent of R
ecip
ients
0
10
20
30
40
50
60
70
80
90
Pre Inf 1N=30
Month 6N=12
Year 1N=7
C-peptide 0.5 ng/mLB. Post Last InfusionIslet Alone Recipients
C-peptide < 0.5 ng/mLC-peptide >= 0.5 ng/mLMissing data
Perc
ent of R
ecip
ients
0
10
20
30
40
50
60
70
80
90
Pre Inf 1N=262
Month 6N=249
Year 1N=225
Year 2N=169
Year 3N=129
C-peptide 0.5 ng/mLB. Post Last Infusion
Islet After Kidney Recipients
C-peptide < 0.5 ng/mLC-peptide >= 0.5 ng/mLMissing data
Perc
ent of R
ecip
ients
0
10
20
30
40
50
60
70
80
90
Pre Inf 1N=30
Month 6N=28
Year 1N=25
Year 2N=23
Year 3N=11
Severe HypoglycemiaA. Post First Infusion (Censored at Re-Infusion before Visit)
Islet Alone Recipients
No severe hypoglycemic episodesSevere hypoglycemic episodeMissing data for recipient without islet graft functionMissing data for recipient with islet graft function
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
90
100
Pre Inf 1N=262
Month 6N=47
Year 1N=20
Severe HypoglycemiaB. Post First Infusion (Censored at Re-Infusion before Visit)
Islet After Kidney Recipients
No severe hypoglycemic episodesSevere hypoglycemic episodeMissing data for recipient without islet graft functionMissing data for recipient with islet graft function
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
90
100
Pre Inf 1N=30
Month 6N=5
Year 1N=2
Severe HypoglycemiaC. Post Last Infusion Islet Alone Recipients
No severe hypoglycemic episodesSevere hypoglycemic episodeMissing data for recipient without islet graft functionMissing data for recipient with islet graft function
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
90
100
Pre Inf 1N=262
Day 30N=262
Month 6N=249
Year 1N=225
Year 2N=169
Year 3N=129
Severe HypoglycemiaD. Post Last Infusion
Islet After Kidney Recipients
No severe hypoglycemic episodesSevere hypoglycemic episodeMissing data for recipient without islet graft functionMissing data for recipient with islet graft function
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
90
100
Pre Inf 1N=30
Day 30N=30
Month 6N=28
Year 1N=25
Year 2N=23
Year 3N=11
Severe HypoglycemiaE. Post Last Infusion
Islet Alone Recipients with Detectable Fasting C-peptide
Severe hypoglycemic episodeMissing data
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
90
100
Pre Inf 1N=92
Day 30N=254
Month 6N=219
Year 1N=177
Year 2N=115
Year 3N=75
Severe HypoglycemiaF. Post Last Infusion
Islet Alone Recipients without Detectable Fasting C-peptide
Severe hypoglycemic episodeMissing data
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
90
100
Pre Inf 1N=170
Day 30N=8
Month 6N=30
Year 1N=48
Year 2N=54
Year 3N=54
Hypoglycemia Status Pre First Infusion and Post Last Infusion
All Allograft Recipients
No hypoglycemic episodesHaving episodes and awarePartial awarenessHypoglycemia unawarenessMissing data for recipient without islet graft functionMissing data for recipient with islet graft function
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
Pre Inf 1N=292
Month 6N=277
Year 1N=250
Year 2N=192
Year 3N=140
Graft Loss or Dysfunction Post Last InfusionA. Islet Alone Recipients
Complete Graft FailureIslet Graft Dysfunction
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
Day 30N=262
Month 6N=249
Year 1N=225
Year 2N=169
Year 3N=129
Graft Loss or Dysfunction Post Last InfusionB. Islet After Kidney Recipients
Complete Graft FailureIslet Graft Dysfunction
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
Day 30N=30
Month 6N=28
Year 1N=25
Year 2N=23
Year 3N=11
Persistence of Islet Graft Function (IA, IAK)
Persistence of Islet Graft Function by Ever Achieving Insulin Independence
Islet Alone RecipientsNot Censored at Re-Infusion
Achievement of Insulin IndependenceA. All Allograft Recipients
Post First Infusion (Not Censored at Re-Infusion)
Days Post First Infusion
Type of AllograftIslet Alone
Islet After Kidney
Achievement of Insulin IndependenceB. Islet Alone Recipients
Post First Infusion (Censored at Re-Infusion)
Achievement of Insulin IndependenceC. Islet Alone Recipients
Post Second Infusion (Recipients Not Insulin Independent after First Infusion,
Censored at Third Infusion)
N 158 76 54 46 35
Days Post Second Infusion
Achievement of Insulin IndependenceD. Islet Alone Recipients
Post Third Infusion (Recipients Not Insulin Independent after First or Second Infusion,
Censored at Fourth Infusion)
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
90
100
Days Post Third Infusion
0 25 50 75 100 125 150 175 200
N 40 20 13 12 12
Persistence of Insulin Independence and Persistence of Graft Function
Islet Alone Recipients Achieving Insulin IndependenceNot Censored at Re-Infusion
Persistence of Insulin IndependenceBy Total Number of Infusions Given Prior to
Achievement of Insulin IndependenceIslet Alone Recipients Achieving Insulin Independence
Composite Outcome (Hypoglycemia and HbA1C)
Post Last InfusionA. Islet Alone Recipients
No severe hypoglycemic episodes and HbA1c < 6.5%No severe hypoglycemic episodes and 6.5% <= HbA1c < 7.0%Severe hypoglycemic episode or HbA1c >= 7.0% with detectable fasting c-peptideSevere hypoglycemic episode or HbA1c >= 7.0% without detectable fasting c-peptideMissing data for recipient without islet graft functionMissing data for recipient with islet graft function
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
Pre Infusion 1N=262
Day 30N=262
Month 6N=249
Year 1N=225
Year 2N=169
Year 3N=129
Composite Outcome (Hypoglycemia and HbA1C)
Post Last InfusionB. Islet After Kidney Recipients
No severe hypoglycemic episodes and HbA1c < 6.5%No severe hypoglycemic episodes and 6.5% <= HbA1c < 7.0%Severe hypoglycemic episode or HbA1c >= 7.0% with detectable fasting c-peptideSevere hypoglycemic episode or HbA1c >= 7.0% without detectable fasting c-peptideMissing data for recipient without islet graft functionMissing data for recipient with islet graft function
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
Pre Infusion 1N=30
Day 30N=30
Month 6N=28
Year 1N=25
Year 2N=23
Year 3N=11
Average Daily Insulin (Units) Taken By Recipients on Insulin Baseline and Post Last Infusion
A. Islet Alone Recipients
233 48 48 31 30
Pre Infusion 1 Month 6 Year 1 Year 2 Year 3
0.0
20.0
40.0
60.0
80.0
100.0A
vera
ge D
aily
Ins
ulin
Use
(U
nits
)
Follow-Up
Average Daily Insulin (Units) Taken By Recipients on Insulin Baseline and Post Last InfusionB. Islet After Kidney Recipients
28 4 4 5 2
Pre Infusion 1 Month 6 Year 1 Year 2 Year 3
0.0
20.0
40.0
60.0
80.0
100.0
Ave
rage
Dai
ly I
nsul
in U
se (
Uni
ts)
Follow-Up
Average Daily Insulin (Units/Kg) Taken By Recipients on InsulinBaseline and Post Last Infusion
A. Islet Alone Recipients
232 47 43 28 29
Pre Infusion 1 Month 6 Year 1 Year 2 Year 3
0
0.2
0.4
0.6
0.8
1.0
1.2
Ave
rage
Dai
ly I
nsul
in U
se (
Uni
ts/k
g)
Follow-Up
Average Daily Insulin (Units/Kg) Taken By Recipients on InsulinBaseline and Post Last InfusionB. Islet After Kidney Recipients
27 4 4 5 2
Pre Infusion 1 Month 6 Year 1 Year 2 Year 3
0
0.2
0.4
0.6
0.8
1.0
1.2A
vera
ge D
aily
Ins
ulin
Use
(U
nits
/kg)
Follow-Up
Percent of Baseline Insulin Used By Recipients on InsulinFollow-Up Post Last Infusion
A. Islet Alone Recipients
48 48 31 29
Month 6 Year 1 Year 2 Year 3
0
50
100
150
Per
cent
of
Bas
elin
e In
sulin
Follow-Up
Percent of Baseline Insulin Used By Recipients on InsulinFollow-Up Post Last Infusion
B. Islet After Kidney Recipients
4 4 5 1
Month 6 Year 1 Year 2 Year 3
0
25
50
75
100
125P
erce
nt o
f B
asel
ine
Insu
lin
Follow-Up
Percent of Baseline Insulin at Follow-Up Post Last InfusionIslet Alone Recipients
who Achieved then Lost Insulin Independence
10 24 23 26
Month 6 Year 1 Year 2 Year 3
0
15
30
45
60
75
90
105
120
135
150
Perc
ent
of
Baselin
e I
nsulin
Follow-Up
Percent of Baseline Insulin at Follow-Up Post Last InfusionIslet Alone Recipients
Never Achieving Insulin Independence
33 22 8 3
Month 6 Year 1 Year 2 Year 3
0
15
30
45
60
75
90
105
120
135
150
Perc
ent
of
Baselin
e I
nsulin
Follow-Up
Primary Outcomes Post First InfusionUp to Re-Infusion, Complete Islet Failure, or Last Follow-UpAccording to Pre-Infusion Recipient, Donor, Procurement,
and Islet Characteristics
Islet Alone Recipients
Primary Outcomes Post First InfusionUp to Re-Infusion, Complete Islet Failure, or Last Follow-UpAccording to Pre-Infusion Recipient, Donor, Procurement,
and Islet CharacteristicsIslet Alone Recipients (continued)
Primary Outcomes Post First InfusionUp to Re-Infusion, Complete Islet Failure, or Last Follow-UpAccording to Pre-Infusion Recipient, Donor, Procurement,
and Islet CharacteristicsIslet Alone Recipients (continued)
Primary Outcomes Post Last InfusionAccording to Pre-Infusion Recipient, Donor,
Procurement, and Islet Characteristics
Primary Outcomes Post Last InfusionAccording to Pre-Infusion Recipient, Donor,
Procurement, and Islet Characteristics (continued)
Primary Outcomes Post Last InfusionAccording to Pre-Infusion Recipient, Donor,
Procurement, and Islet Characteristics (continued)
Primary Outcomes Post Last InfusionAccording to Pre-Infusion Recipient, Donor,
Procurement, and Islet Characteristics (continued)
Fasting Plasma Glucose (mg/dL)Pre Infusion and Post Last Infusion
231 171 52 186 148 84 57
Values greater than 400 mg/dL are not displayed
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3
0
50
100
150
200
250
300
350
400
mg/
dL
Follow-Up
28 19 3 22 16 12 6
Values greater than 400 mg/dL are not displayed
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3
0
50
100
150
200
250
300
350
400
mg/
dLFollow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
HbA1C (%)
Pre Infusion and Post Last Infusion
233 156 51 177 142 83 57
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3
2.5
5.0
7.5
10.0
12.5
%
Follow-Up
27 18 4 21 16 13 5
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3
2.5
5.0
7.5
10.0
12.5
%
Follow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
Basal Plasma C-Peptide (ng/mL)Pre Infusion and Post Last Infusion
230 152 46 177 153 94 81
Values greater than 6 ng/ml are not displayed
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3
0
1
2
3
4
5
6
ng/m
L
Follow-Up
24 17 2 20 14 10 2
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3
0
1
2
3
4
5
6
ng/m
L
Follow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
Fasting Plasma Glucose (mg/dL)Pre Infusion and Post Last Infusion
Islet Alone Recipients with One Infusion
66 44 32 14 14
Pre Inf 1 Month 6 Year 1 Year 2 Year 3
0
50
100
150
200
250
300
350
400
mg/d
L
Follow-Up
HbA1C (%)
Pre-Infusion and Post Last Infusion Islet Alone Recipients with One Infusion
63 42 29 15 14
Pre Inf 1 Month 6 Year 1 Year 2 Year 3
2.5
5.0
7.5
10.0
12.5
%
Follow-Up
Basal Plasma C-Peptide (ng/mL)Pre Infusion and Post Last Infusion
Islet Alone Recipients with One Infusion
62 41 37 22 25
Pre Inf 1 Month 6 Year 1 Year 2 Year 3
0
1
2
3
4
5
6
ng/m
L
Follow-Up
Fasting Plasma Glucose (mg/dL)Pre Infusion and Post Last Infusion
Islet Alone Recipients with Two Infusions
117 120 103 83 50 35
Values greater than 400 mg/dL are not displayed
Pre Inf 1 Pre Inf 2 Month 6 Year 1 Year 2 Year 3
0
50
100
150
200
250
300
350
400
mg/d
L
Follow-Up
HbA1C (%)
Pre Infusion and Post Last InfusionIslet Alone Recipients with Two Infusions
120 110 98 82 48 35
Pre Inf 1 Pre Inf 2 Month 6 Year 1 Year 2 Year 3
2.5
5.0
7.5
10.0
12.5
%
Follow-Up
Basal Plasma C-Peptide (ng/mL)Pre Infusion and Post Last Infusion
Islet Alone Recipients with Two Infusions
118 107 98 84 54 42
Values greater than 6 ng/mL are not displayed
Pre Inf 1 Pre Inf 2 Month 6 Year 1 Year 2 Year 3
0
1
2
3
4
5
6
ng/m
L
Follow-Up
Fasting Plasma Glucose (mg/dL)Pre Infusion and Post Last Infusion
Islet Alone Recipients with Three Infusions
45 48 49 37 32 20 8
Values greater than 400 mg/dL are not displayed
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3
0
50
100
150
200
250
300
350
400
mg/d
L
Follow-Up
HbA1C (%)
Pre Infusion and Post Last InfusionIslet Alone Recipients with Three Infusions
47 43 48 35 30 20 8
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3
2.5
5.0
7.5
10.0
12.5
%
Follow-Up
Basal Plasma C-Peptide (ng/mL)Pre Infusion and Post Last Infusion
Islet Alone Recipients with Three Infusions
47 42 43 36 31 18 14
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3
0
1
2
3
4
5
6
ng/m
L
Follow-Up
Fasting Plasma Glucose (mg/dL) Post Last InfusionRecipients Who Ever Achieved Insulin Independence
140 124 110 73 52
Glucose values greater than 400 mg/dl pre-infusion were removed for display
Pre Inf 1 Month 6 Year 1 Year 2 Year 3
0
50
100
150
200
250
300
350
400
mg/
dL
Follow-Up
16 15 12 10 5
Glucose values greater than 400 mg/dl pre-infusion were removed for display
Pre Inf 1 Month 6 Year 1 Year 2 Year 3
0
50
100
150
200
250
300
350
400
mg/
dL
Follow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
Fasting Plasma Glucose (mg/dL) Post Last InfusionRecipients Who Never Achieved Insulin Independence
70 53 36 11 5
Glucose values greater than 400 mg/dl pre-infusion were removed for display
Pre Inf 1 Month 6 Year 1 Year 2 Year 3
0
50
100
150
200
250
300
350
400
mg/
dL
Follow-Up
9 7 4 2 1
Glucose values greater than 400 mg/dl pre-infusion were removed for display
Pre Inf 1 Month 6 Year 1 Year 2 Year 3
0
50
100
150
200
250
300
350
400
mg/
dL
Follow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
HbA1C (%) Post Last Infusion
Recipients Who Ever Achieved Insulin Independence
145 119 109 73 52
Pre Inf 1 Month 6 Year 1 Year 2 Year 3
2.5
5.0
7.5
10.0
12.5
%
Follow-Up
16 14 12 10 5
Pre Inf 1 Month 6 Year 1 Year 2 Year 3
2.5
5.0
7.5
10.0
12.5
%
Follow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
HbA1C (%) Post Last Infusion
Recipients Who Never Achieved Insulin Independence
70 49 31 10 5
Pre Inf 1 Month 6 Year 1 Year 2 Year 3
2.5
5.0
7.5
10.0
12.5
%
Follow-Up
9 7 4 3 0
Pre Inf 1 Month 6 Year 1 Year 2 Year 3
2.5
5.0
7.5
10.0
12.5
%
Follow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
Basal Plasma C-Peptide (ng/mL) Post Last InfusionRecipients Who Ever Achieved Insulin Independence
142 121 109 65 62
C-peptide values greater than 6 are removed for display purposes
Pre Inf 1 Month 6 Year 1 Year 2 Year 3
0
1
2
3
4
5
6
ng/m
L
Follow-Up
15 15 12 9 2
Pre Inf 1 Month 6 Year 1 Year 2 Year 3
0
1
2
3
4
5
6
ng/m
L
Follow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
Basal Plasma C-Peptide (ng/mL) Post Last InfusionRecipients Who Never Achieved Insulin Independence
70 47 40 27 17
C-peptide values greater than 6 are removed for display purposes
Pre Inf 1 Month 6 Year 1 Year 2 Year 3
0
1
2
3
4
5
6
ng/m
L
Follow-Up
8 5 2 1 0
Pre Inf 1 Month 6 Year 1 Year 2 Year 3
0
1
2
3
4
5
6
ng/m
L
Follow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
Fasting Plasma Glucose (mg/dL) Pre and Post First Infusion
Insulin Independent Recipients
231 11 25 103 98
Glucose values greater than 400 mg/dl pre-infusion were removed for display
Pre Inf 1 Day 7 Day 30 Month 6 Year 1
0
100
200
300
400
mg/
dL
Follow-Up
28 2 5 9 5
Glucose values greater than 400 mg/dl pre-infusion were removed for display
Pre Inf 1 Day 7 Day 30 Month 6 Year 1
0
100
200
300
400
mg/
dL
Follow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
Fasting Plasma Glucose (mg/dL) Pre and Post First Infusion
Insulin Dependent Recipients
231 211 203 82 72
Glucose values greater than 400 mg/dl pre-infusion were removed for display
Pre Inf 1 Day 7 Day 30 Month 6 Year 1
0
100
200
300
400
mg/
dL
Follow-Up
28 24 21 13 11
Glucose values greater than 400 mg/dl pre-infusion were removed for display
Pre Inf 1 Day 7 Day 30 Month 6 Year 1
0
100
200
300
400
mg/
dL
Follow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
HbA1C (%)
Pre and Post First InfusionInsulin Independent Recipients
233 19 98 92
Pre Inf 1 Day 30 Month 6 Year 1
2.5
5.0
7.5
10.0
12.5
%
Follow-Up
27 3 9 5
Pre Inf 1 Day 30 Month 6 Year 1
2.5
5.0
7.5
10.0
12.5
%
Follow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
HbA1C (%)
Pre and Post First InfusionInsulin Dependent Recipients
233 125 75 67
Pre Inf 1 Day 30 Month 6 Year 1
2.5
5.0
7.5
10.0
12.5
%
Follow-Up
27 9 10 11
Pre Inf 1 Day 30 Month 6 Year 1
2.5
5.0
7.5
10.0
12.5
%
Follow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
Basal Plasma C-Peptide (ng/mL) Pre and Post First Infusion
Insulin Independent Recipients
230 8 23 100 97
C-peptide values greater than 6 ng/mL are removed for presentation
Pre Inf 1 Day 7 Day 30 Month 6 Year 1
0
1
2
3
4
5
6
ng/m
L
Follow-Up
24 1 4 10 5
Pre Inf 1 Day 7 Day 30 Month 6 Year 1
0
1
2
3
4
5
6
ng/m
L
Follow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
Basal Plasma C-Peptide (ng/mL) Pre and Post First Infusion
Insulin Dependent Recipients
230 192 196 76 78
Pre Inf 1 Day 7 Day 30 Month 6 Year 1
0
1
2
3
4
5
6
ng/m
L
Follow-Up
24 20 20 12 11
Pre Inf 1 Day 7 Day 30 Month 6 Year 1
0
1
2
3
4
5
6
ng/m
L
Follow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
Recipients with Fasting Blood Glucose 126 mg/dLPost Last Infusion by Insulin Status
A. Islet Alone Recipients
Insulin Status Independent Dependent
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
90
100
Pre Infusion 1N=0 :231
Month 6N=113 :67
Year 1N=80 :64
Year 2N=41 :40
Year 3N=19 :37
Recipients with Fasting Blood Glucose 126 mg/dLPost Last Infusion by Insulin Status
B. Islet After Kidney Recipients
Insulin Status Independent Dependent
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
90
100
Pre Infusion 1N=0 :28
Month 6N=12 :9
Year 1N=7 :9
Year 2N=4 :8
Year 3N=0 :5
Insulin Dependent Recipients with Basal C-Peptide 0.5 ng/mL
Post Last InfusionA. Islet Alone Recipients
Perc
ent of R
ecip
ients
0
10
20
30
40
50
60
70
80
90
100
Pre Inf 1N=230
Month 6N=65
Year 1N=74
Year 2N=62
Year 3N=62
Insulin Dependent Recipients with Basal C-Peptide 0.5 ng/mL
Post Last InfusionB. Islet After Kidney Recipients
Perc
ent of R
ecip
ients
0
10
20
30
40
50
60
70
80
90
100
Pre Inf 1N=24
Month 6N=9
Year 1N=8
Year 2N=8
Year 3N=1
Recipients with HbA1C < 6.5%
Post Last Infusion by Insulin StatusA. Islet Alone Recipients
Insulin Status Independent Dependent
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
90
100
Pre Infusion 1N=0 :233
Month 6N=108 :64
Year 1N=79 :60
Year 2N=40 :40
Year 3N=20 :36
Recipients with HbA1C < 6.5%
Post Last Infusion by Insulin StatusB. Islet After Kidney Recipients
Insulin Status Independent Dependent
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
70
80
90
100
Pre Infusion 1N=0 :27
Month 6N=11 :9
Year 1N=7 :9
Year 2N=4 :9
Year 3N=1 :4
Pre-Infusion Recipient Lab Summary by Infusion SequenceIslet Alone Recipients
Pre-Infusion Recipient Lab Summary by Infusion SequenceIslet After Kidney Recipients
Metabolic Summary by Follow-Up Post Last InfusionIslet Alone Recipients
Metabolic Summary by Follow-Up Post Last InfusionIslet After Kidney Recipients
Metabolic Summary Post Last Infusion by Insulin StatusIslet Alone Recipients
Secondary Complications of DiabetesPre First Infusion and Post Last Infusion
All Allograft Recipients
Secondary Complications of DiabetesPre First Infusion and Post Last Infusion
All Allograft Recipients (continued)
Secondary Complications of DiabetesPre First Infusion and Post Last Infusion
All Allograft Recipients (continued)
Secondary Complications of DiabetesPre First Infusion and Post Last Infusion
All Allograft Recipients (continued)
Ocular ComplicationsPre First Infusion and Post last Infusion
All Allograft Recipients
Ocular ComplicationsPre First Infusion and Post last Infusion
All Allograft Recipients (continued)
Chapter 6: Liver, Kidney, Lipid and PRA Effects
Incidence of Abnormal Liver Function Testsat Any Scheduled Time Post First Infusion
All Allograft Recipients
and at Month 6, Year 1, Year 2, and Year 3 after the last infusion procedure occurs.Lab values analyzed in this Exhibit are taken prior to each subsequent infusion
>=3X ULN2-3X ULN1-2X ULN
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
ALT AST Alkaline Phosphatase Total Bilirubin
ALT (IU/L) Pre Infusion and Post Last Infusion
243 170 54 174 136 75 53
Values greater than 150 IU/L are removed for display
PreInf 1
PreInf 2
PreInf 3
Month 6 Year 1 Year 2 Year 3
0
25
50
75
100
125
150
IU/L
Follow-Up
29 20 2 22 16 13 5
PreInf 1
PreInf 2
PreInf 3
Month 6 Year 1 Year 2 Year 3
0
25
50
75
100
125
150
IU/L
Follow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
AST (IU/L) Pre Infusion and Post Last Infusion
243 170 54 174 136 75 53
Values greater than 120 IU/L are removed for display
PreInf 1
PreInf 2
PreInf 3
Month 6 Year 1 Year 2 Year 3
0
20
40
60
80
100
120
IU/L
Follow-Up
29 20 2 22 16 13 5
PreInf 1
PreInf 2
PreInf 3
Month 6 Year 1 Year 2 Year 3
0
20
40
60
80
100
120
IU/L
Follow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
Alkaline Phosphatase (IU/L) Pre Infusion and Post Last Infusion
238 166 52 169 136 76 53
Values greater than 350 IU/L are removed for display
PreInf 1
PreInf 2
PreInf 3
Month 6 Year 1 Year 2 Year 3
0
50
100
150
200
250
300
350
IU/L
Follow-Up
27 20 2 22 16 13 5
PreInf 1
PreInf 2
PreInf 3
Month 6 Year 1 Year 2 Year 3
0
50
100
150
200
250
300
350
IU/L
Follow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
Total Bilirubin (mg/dL) Pre Infusion and Post Last Infusion
239 169 53 168 136 76 50
PreInf 1
PreInf 2
PreInf 3
Month 6 Year 1 Year 2 Year 3
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
mg/
dL
Follow-Up
29 20 2 22 16 13 6
PreInf 1
PreInf 2
PreInf 3
Month 6 Year 1 Year 2 Year 3
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
mg/
dL
Follow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
Incidence of Abnormal Lipid Testsat Any Scheduled Time Post First Infusion
All Allograft Recipients
and at Month 6, Year 1, Year 2, and Year 3 after the last infusion procedure occurs.Lab values analyzed in this Exhibit are taken prior to each subsequent infusion
2-3X ULN1-2X ULN
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
Total Cholesterol Triglycerides
Total Cholesterol (mg/dL) Pre Infusion and Post Last Infusion
237 147 47 164 143 81 55
PreInf 1
PreInf 2
PreInf 3
Month 6 Year 1 Year 2 Year 3
0
50
100
150
200
250
300
350
mg/
dL
Follow-Up
27 12 1 19 15 13 6
PreInf 1
PreInf 2
PreInf 3
Month 6 Year 1 Year 2 Year 3
0
50
100
150
200
250
300
350
mg/
dL
Follow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
HDL (mg/dL) Pre Infusion and Post Last Infusion
234 137 42 162 141 79 55
PreInf 1
PreInf 2
PreInf 3
Month 6 Year 1 Year 2 Year 3
0
25
50
75
100
125
150
mg/
dL
Follow-Up
27 12 1 18 15 13 6
PreInf 1
PreInf 2
PreInf 3
Month 6 Year 1 Year 2 Year 3
0
25
50
75
100
125
150
mg/
dL
Follow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
LDL (mg/dL) Pre Infusion and Post Last Infusion
234 137 41 161 141 79 55
PreInf 1
PreInf 2
PreInf 3
Month 6 Year 1 Year 2 Year 3
0
50
100
150
200
250
300
mg/
dL
Follow-Up
27 12 1 18 15 13 6
PreInf 1
PreInf 2
PreInf 3
Month 6 Year 1 Year 2 Year 3
0
50
100
150
200
250
300
mg/
dL
Follow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
Triglycerides (mg/dL) Pre Infusion and Post Last Infusion
237 146 47 164 143 81 55
PreInf 1
PreInf 2
PreInf 3
Month 6 Year 1 Year 2 Year 3
0
50
100
150
200
250
300
350
400
450
mg/
dL
Follow-Up
27 12 1 19 15 13 6
PreInf 1
PreInf 2
PreInf 3
Month 6 Year 1 Year 2 Year 3
0
50
100
150
200
250
300
350
400
450
mg/
dL
Follow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
Incidence of Increase in Serum Creatinine (mg/dL) Greater than 0.5 from Baseline
at Any Scheduled Time Post First InfusionAll Allograft Recipients
and at Month 6, Year 1, Year 2, and Year 3 after the last infusion procedure occurs.Lab values analyzed in this Exhibit are taken prior to each subsequent infusion
>1.0 mg/dL increase from baseline0.5 - 1.0 mg/dL increase from baseline
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
Islet Alone Islet After Kidney
Serum Creatinine (mg/dL) Pre Infusion and Post Last Infusion
245 173 54 182 151 88 59
PreInf 1
PreInf 2
PreInf 3
Month 6 Year 1 Year 2 Year 3
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
mg/
dL
Follow-Up
30 19 3 22 16 12 6
PreInf 1
PreInf 2
PreInf 3
Month 6 Year 1 Year 2 Year 3
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
mg/
dL
Follow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
Calculated Creatinine Clearance (mL/min/1.73m2)Pre Infusion and Post Last Infusion
193 90 23 99 94 28 15
PreInf 1
PreInf 2
PreInf 3
Month 6 Year 1 Year 2 Year 3
0
50
100
150
200
250
mL/
min
/1.7
3m2
Follow-Up
17 5 0 9 11 7 3
PreInf 1
PreInf 2
PreInf 3
Month 6 Year 1 Year 2 Year 3
0
50
100
150
200
250
mL/
min
/1.7
3m2
Follow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
GFR (mL/min/1.73m2)Pre Infusion and Post Last Infusion
245 173 54 185 152 88 59
Four values greater than 180 ml/min/1.73 m2 have been removed for display
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3
0
30
60
90
120
150
180
ml/m
in/1
.73
m2
Follow-Up
30 19 3 22 16 12 6
One Value greater than 180 ml/min/1.73 m2 has been removed for display
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3
0
30
60
90
120
150
180
ml/m
in/1
.73
m2
Follow-Up
A. Islet Alone Recipients B. Islet After Kidney Recipients
Class I PRA (%)Pre Infusion and Post Last Infusion
Islet Alone Recipients
214 147 45 104 79 51 32
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3
0
10
20
30
40
50
60
70
80
90
100
%
Follow-Up
Change in Class I PRA from Pre First InfusionPre Subsequent Infusion and Post Last Infusion
Islet Alone Recipients
136 42 99 74 48 28
Pre Inf 2 Pre Inf 3 Month 6 Year 1 Year 2 Year 3
-25
0
25
50
75
100
Cha
nge
from
Pre
Inf
usio
n 1
Follow-Up
Class I PRA Post Last InfusionIslet Alone Recipients with Complete Graft Loss
4 6 7 3
Month 6 Year 1 Year 2 Year 3
0
10
20
30
40
50
60
70
80
90
100
%
Follow-Up
Class I PRA Post Last InfusionIslet Alone Recipients without Complete Graft Loss
100 73 44 29
Month 6 Year 1 Year 2 Year 3
0
10
20
30
40
50
60
70
80
90
100
%
Follow-Up
Chapter 7: Adverse Events
Percent of Recipients with an Adverse Event (AE) or Serious Adverse Event (SAE)
in Year 1 Post First Infusion
Total Number of Adverse Events and Serious Adverse Events
in Year 1 Post First Infusion
Percent of Recipients with a Serious Adverse Eventin Year 1 Post First Infusion by Year of First Infusion
All Allograft Recipients
Any SAESAE related to either the infusion procedure or immunosupressionSAE related to the infusion procedureSAE related to immunosupression
Per
cent
of R
ecip
ient
s
0
10
20
30
40
50
60
Year of First Infusion1999N=6
2000N=12
2001N=35
2002N=69
2003N=39
2004N=46
2005N=51
Serious Adverse Event Type by Relatedness to Islet Infusion or Immunosuppression
Outcome of Serious Adverse Events by Relatedness to Islet Infusion or Immunosuppression
Serious Adverse Events MedDRA System/Organ Classby Relatedness to Islet Infusion or Immunosuppression
Serious Adverse Events MedDRA System/Organ Classby Relatedness to Islet Infusion or Immunosuppression
(continued)
Most Common Serious Adverse EventsIslet Alone Recipients
Most Common Serious Adverse EventsIslet After Kidney Recipients
Most Common Serious Adverse Events Reported Within One Year of Any Infusion
All Allograft Recipients
Most Common Serious Adverse Events Reported More than One Year after Any Infusion
All Allograft Recipients
Summary of Reported Neoplasms
Listing of Reported Hemorrhages and Portal Vein Thromboses
All Allograft Recipients
Listing of Reported Hemorrhages and Portal Vein Thromboses
All Allograft Recipients (continued)
Listing of Reported Hemorrhages and Portal Vein Thromboses
All Allograft Recipients (continued)
Number of Days Hospitalized at Infusion (from Admission to Discharge)
by Infusion SequenceIslet Alone Recipients
243 170 48
1 2 3
0
5
10
15
20
Num
ber
of
Days
Infusion Sequence
Number of Days Hospitalized at Infusion (from Admission to Discharge)
by Infusion SequenceIslet After Kidney Recipients
29 20 3
1 2 3
0
5
10
15
20
Num
ber
of
Days
Infusion Sequence
Hospitalization Experienced Post Last Infusion by Total Number of Infusions Received
Islet Alone Recipients
Hospitalization Experienced Post Last Infusion by Total Number of Infusions Received
Islet After Kidney Recipients
Chapter 8: Registry Data Quality Review
Expected and Submitted Forms by Infusion SequenceAll Allograft Recipients
Expected and Submitted Follow-Up Forms Post Last infusion
All Allograft Recipients
Extent of Follow-Up Post Last InfusionAll Allograft Recipients
CITR Coordinating Center(July 2006 – July 2007)
PI: Franca Barton
Co-PI: Donald Stablein
Matthew Beyers
Bryan Calaway
Yamini Damodharan
Krista Huang
Jessica Long
Glenn Tucker
Chuck Wagner
Steve Wease
CITR Committees
Scientific Advisory Committee (SAC)
Compliance Committee
Data Elements Committee
Publications/Presentations Committee
Transplant Coordinators’/Data Managers’ Committee
CITR Scientific Advisory Committee (SAC)
Chair: Bernhard J. Hering
Michael Cecka
Philip Cryer
Mary D. Ellison
Olle Korsgren
Jerry P. Palmer
Camillo Ricordi
CITR Compliance Committee
Michael Appel
Parastoo Dinyari
E. Brian Flanagan
Fouad Kandeel
Eileen M. Markmann
Jamen Parkey
Marti Sears
Elyse Stuart
CITR Data Elements Committee
Chair: Marc Garfinkel
David Baidal
Enrico Cagliero
Fouad Kandeel
Dixon Kaufman
Melissa Roberts
Marti Sears
CITR Publications/Presentations Committee
Chair: Rodolfo Alejandro
Michael Appel
Nancy Bridges
Elizabeth Holbrook
Ali Naji
Bashoo Naziruddin
Craig Smith
CITR Transplant Coordinators’/Data Managers’ Committee
Chair: Melissa Roberts
Jarrett Anderson
Shama Bader
David Baidal
LeAnn Batterson
Jennifer Bishop
Parastoo Dinyari
Jane Fasbender
Beverly Fleckton
Charlotte Garwood
Susan George
Debbie Grice
Darrell Grimes
Jeannette Hacker
Michael Hanschew
Celia Hartigan
Nancy Radke
Violeta Raverdy
Marilyn Reeve
Payam Salehi
Ammar Saoud
Grace Sauzier
Marti Sears
Jill Sheedy
KD Shiang
Elyse Stuart
Joanna Sung
Pat Swanson
Shameka Thomas
Heather Turgeon
Piotr Witkowski
Robin Jevne
Jenny Joseph
Debra Kemp
Carol Kramer
Arlene LaRose
Mark Lockwood
Eileen Markmann
Joan Martellotto
Marli McCulloch-Olson
Joan McElroy
Melissa McGraw
Suzanne Miller
Bashoo Naziruddin
Lori Otken
Maral Palanjian
Jamen Parkey
