Trial Outcomes & Findings for Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol (NCT NCT00679042)
NCT ID: NCT00679042
Last Updated: 2024-10-22
Results Overview
Safety endpoints: Incidence and severity of events related to islet infusion, immunosuppression, and islet preparations
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
21 participants
Primary outcome timeframe
From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year
Results posted on
2024-10-22
Participant Flow
Potentially eligible patients with diabetes underwent a two-part screening phase to determine eligibility, followed by a waiting list period (as needed). The first subject consented on September 5, 2007. The last subject consented on November 4, 2014.
Potentially eligible patients with diabetes were to undergo a two-part screening phase to determine eligibility, followed by a waiting list period (as needed).
Participant milestones
| Measure |
Treatment
All subjects will receive up to 3 transplantations of allogeneic human islets of Langerhans.
Islets of Langerhans transplantation: Each subject may receive 1-3 transplantations of allogeneic human islets of Langerhans and the following medications:
Basiliximab 20 mg iv 2 hours before transplant and 20 mg iv 2 weeks post-transplant; Tacrolimus 1 mg p.o. bid adjusted to reach target trough levels of 3-6 ng/ml; Sirolimus 0.2 mg/kg loading dose, then 0.1 mg/kg p.o. daily adjusted to reach target trough levels of 10-15 ng/ml during the first 3 months post transplant and 7-10 ng/ml thereafter; Etanercept 50 mg iv 1 hour before transplant and 25 mg s.c. on days 3, 7,and 10 post-transplant; Exenatide 5-mcg s.c. bid for 1 week, then 10 mcg bid for 6 months after each transplant
|
|---|---|
|
Transplant + 1 Year Follow Up
STARTED
|
21
|
|
Transplant + 1 Year Follow Up
COMPLETED
|
19
|
|
Transplant + 1 Year Follow Up
NOT COMPLETED
|
2
|
|
5-Year Follow Up
STARTED
|
19
|
|
5-Year Follow Up
COMPLETED
|
5
|
|
5-Year Follow Up
NOT COMPLETED
|
14
|
|
10-Year Follow Up
STARTED
|
5
|
|
10-Year Follow Up
COMPLETED
|
0
|
|
10-Year Follow Up
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Treatment
All subjects will receive up to 3 transplantations of allogeneic human islets of Langerhans.
Islets of Langerhans transplantation: Each subject may receive 1-3 transplantations of allogeneic human islets of Langerhans and the following medications:
Basiliximab 20 mg iv 2 hours before transplant and 20 mg iv 2 weeks post-transplant; Tacrolimus 1 mg p.o. bid adjusted to reach target trough levels of 3-6 ng/ml; Sirolimus 0.2 mg/kg loading dose, then 0.1 mg/kg p.o. daily adjusted to reach target trough levels of 10-15 ng/ml during the first 3 months post transplant and 7-10 ng/ml thereafter; Etanercept 50 mg iv 1 hour before transplant and 25 mg s.c. on days 3, 7,and 10 post-transplant; Exenatide 5-mcg s.c. bid for 1 week, then 10 mcg bid for 6 months after each transplant
|
|---|---|
|
Transplant + 1 Year Follow Up
Withdrawal by Subject
|
2
|
|
5-Year Follow Up
In follow-up (ongoing)
|
6
|
|
5-Year Follow Up
Death
|
1
|
|
5-Year Follow Up
Did not consent to continue into 10-year follow up
|
7
|
|
10-Year Follow Up
In follow-up (ongoing)
|
5
|
Baseline Characteristics
Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol
Baseline characteristics by cohort
| Measure |
Treatment
n=21 Participants
All subjects will receive up to 3 transplantations of allogeneic human islets of Langerhans.
Islets of Langerhans transplantation: Each subject may receive 1-3 transplantations of allogeneic human islets of Langerhans and the following medications:
Basiliximab 20 mg iv 2 hours before transplant and 20 mg iv 2 weeks post-transplant; Tacrolimus 1 mg p.o. bid adjusted to reach target trough levels of 3-6 ng/ml; Sirolimus 0.2 mg/kg loading dose, then 0.1 mg/kg p.o. daily adjusted to reach target trough levels of 10-15 ng/ml during the first 3 months post transplant and 7-10 ng/ml thereafter; Etanercept 50 mg iv 1 hour before transplant and 25 mg s.c. on days 3, 7,and 10 post-transplant; Exenatide 5-mcg s.c. bid for 1 week, then 10 mcg bid for 6 months after each transplant
|
|---|---|
|
Age, Continuous
|
47.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
|
weight
|
63.8 kg
n=5 Participants
|
|
height
|
165 cm
n=5 Participants
|
|
BMI
|
23.4 kg/m^2
STANDARD_DEVIATION 2 • n=5 Participants
|
PRIMARY outcome
Timeframe: From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 yearPopulation: Intent to treat and as treated
Safety endpoints: Incidence and severity of events related to islet infusion, immunosuppression, and islet preparations
Outcome measures
| Measure |
Treatment
n=21 Participants
All subjects will receive up to 3 transplantations of allogeneic human islets of Langerhans.
Islets of Langerhans transplantation: Each subject may receive 1-3 transplantations of allogeneic human islets of Langerhans and the following medications:
Basiliximab 20 mg iv 2 hours before transplant and 20 mg iv 2 weeks post-transplant; Tacrolimus 1 mg p.o. bid adjusted to reach target trough levels of 3-6 ng/ml; Sirolimus 0.2 mg/kg loading dose, then 0.1 mg/kg p.o. daily adjusted to reach target trough levels of 10-15 ng/ml during the first 3 months post transplant and 7-10 ng/ml thereafter; Etanercept 50 mg iv 1 hour before transplant and 25 mg s.c. on days 3, 7,and 10 post-transplant; Exenatide 5-mcg s.c. bid for 1 week, then 10 mcg bid for 6 months after each transplant
|
|---|---|
|
Treatment Emergent Adverse Events
TEAE
|
21 Participants
|
|
Treatment Emergent Adverse Events
Serious TEAE
|
11 Participants
|
|
Treatment Emergent Adverse Events
TEAEs rated as severe or beyond
|
16 Participants
|
|
Treatment Emergent Adverse Events
TEAEs leading to death or discontinuation
|
0 Participants
|
PRIMARY outcome
Timeframe: One year after islet transplantPopulation: Intent to treat/as treated
A successful primary endpoint was defined as HbA1c ≤ 6.5% at the one-year follow-up visit and absence of severe hypoglycemic events (SHE) from Day 28 post-first transplant to 1 year after first and last transplant. The primary analysis was to estimate the true rate of the composite favorable outcome at 1 year following first and last transplant in patients in the ITT population.
Outcome measures
| Measure |
Treatment
n=21 Participants
All subjects will receive up to 3 transplantations of allogeneic human islets of Langerhans.
Islets of Langerhans transplantation: Each subject may receive 1-3 transplantations of allogeneic human islets of Langerhans and the following medications:
Basiliximab 20 mg iv 2 hours before transplant and 20 mg iv 2 weeks post-transplant; Tacrolimus 1 mg p.o. bid adjusted to reach target trough levels of 3-6 ng/ml; Sirolimus 0.2 mg/kg loading dose, then 0.1 mg/kg p.o. daily adjusted to reach target trough levels of 10-15 ng/ml during the first 3 months post transplant and 7-10 ng/ml thereafter; Etanercept 50 mg iv 1 hour before transplant and 25 mg s.c. on days 3, 7,and 10 post-transplant; Exenatide 5-mcg s.c. bid for 1 week, then 10 mcg bid for 6 months after each transplant
|
|---|---|
|
Number of Subjects Reaching the Efficacy Goal
Success at 1 yr post first transplant
|
8 Participants
|
|
Number of Subjects Reaching the Efficacy Goal
Success at 1 yr post last transplant
|
11 Participants
|
SECONDARY outcome
Timeframe: 1 year after islet infusionPopulation: Intent to treat
Number of patients presenting with insulin independence, including: Absence of exogenous insulin injection reported at Day 365. * Fasting capillary glucose level not exceeding 140 mg/dL (7.8 mmol/L) more than 3 times in a week (based on measuring capillary glucose levels a minimum of 7 times in a 7-day period) at Day 365 ± 28 days. * Fasting plasma glucose level ≤ 126 mg/dL (7.0 mmol/L) at Day 365 ± 28 days (if the fasting plasma glucose level is \> 126 mg/dL \[7.0 mmol/L\], it must have been confirmed in an additional 1 out of 2 measurements). * Two-hour post-prandial capillary glucose not exceeding 180 mg/dL (10.0 mmol/L) more than 1 out of every 7 times in a week (based on measuring capillary glucose levels a minimum of 7 times in a 7-day period) at Day 365 ± 28 days. * Evidence of endogenous insulin production defined as fasting or stimulated C-peptide levels ≥ 0.5 ng/mL (0.16 nmol/L) at Day 365 ± 28 days
Outcome measures
| Measure |
Treatment
n=21 Participants
All subjects will receive up to 3 transplantations of allogeneic human islets of Langerhans.
Islets of Langerhans transplantation: Each subject may receive 1-3 transplantations of allogeneic human islets of Langerhans and the following medications:
Basiliximab 20 mg iv 2 hours before transplant and 20 mg iv 2 weeks post-transplant; Tacrolimus 1 mg p.o. bid adjusted to reach target trough levels of 3-6 ng/ml; Sirolimus 0.2 mg/kg loading dose, then 0.1 mg/kg p.o. daily adjusted to reach target trough levels of 10-15 ng/ml during the first 3 months post transplant and 7-10 ng/ml thereafter; Etanercept 50 mg iv 1 hour before transplant and 25 mg s.c. on days 3, 7,and 10 post-transplant; Exenatide 5-mcg s.c. bid for 1 week, then 10 mcg bid for 6 months after each transplant
|
|---|---|
|
Number of Patients Presenting With Insulin Independence at Day 365 Post First and Last Transplant
First Tx Day 365 Fasting plasma glucose ≤126 mg/dL
|
10 Participants
|
|
Number of Patients Presenting With Insulin Independence at Day 365 Post First and Last Transplant
Last Tx Day 365 Fasting plasma glucose ≤126 mg/dL
|
11 Participants
|
|
Number of Patients Presenting With Insulin Independence at Day 365 Post First and Last Transplant
First Tx Day 365 Post-prandial capillary glucose in a week: Not exceeding 180 mg/dL more than 1X/7X
|
5 Participants
|
|
Number of Patients Presenting With Insulin Independence at Day 365 Post First and Last Transplant
First Tx Day 365 C-peptide (fasting or stimulated) ≥0.5 ng/mL
|
10 Participants
|
|
Number of Patients Presenting With Insulin Independence at Day 365 Post First and Last Transplant
Last Tx Day 365 C-peptide (fasting or stimulated) ≥0.5 ng/mL
|
10 Participants
|
|
Number of Patients Presenting With Insulin Independence at Day 365 Post First and Last Transplant
First Tx Day 365 Absence of exogenous insulin
|
10 Participants
|
|
Number of Patients Presenting With Insulin Independence at Day 365 Post First and Last Transplant
Last Tx Day 365 Absence of exogenous insulin
|
12 Participants
|
|
Number of Patients Presenting With Insulin Independence at Day 365 Post First and Last Transplant
First Tx Day 365 Fasting capillary glucose in a week not exceeding 140 mg/dL more than 3X
|
7 Participants
|
|
Number of Patients Presenting With Insulin Independence at Day 365 Post First and Last Transplant
Last Tx Day 365 Fasting capillary glucose in a week not exceeding 140 mg/dL more than 3X
|
4 Participants
|
|
Number of Patients Presenting With Insulin Independence at Day 365 Post First and Last Transplant
Last Tx Day 365 Post-prandial capillary glucose in a week: Not exceeding 180 mg/dL more than 1X/7X
|
3 Participants
|
SECONDARY outcome
Timeframe: One year after the last transplantPopulation: ITT
Hypoglycemic episodes will be measured by the Ryan hypoglycemic (HYPO) Score derived from the number and severity of hypoglycemic episodes recorded throughout the follow-up phase from Day 28 to Day 365. (From Ryan et al., 2004) "A HYPO score was generated based on a combination of scores from the 4 weeks of readings and the patients' self-reported episodes over the previous year using the scoring system found in online appendix 2 (available at http://diabetes.diabetesjournals.org). The record sheets returned by the patients were analyzed for the number of episodes of glucose values recorded as \<2.5 mmol/l and between 2.5 and 2.9 mmol/l. Points were awarded if symptoms were absent or were neuroglycopenic rather than autonomic... Thus the more severe the problem with hypoglycemia, the higher the score." A Ryan score ranges from 0 (no event) to a cumulative sum of episode points of total events reported during the 4 weeks then multiplied by 13 to provide a 1-year value.
Outcome measures
| Measure |
Treatment
n=21 Participants
All subjects will receive up to 3 transplantations of allogeneic human islets of Langerhans.
Islets of Langerhans transplantation: Each subject may receive 1-3 transplantations of allogeneic human islets of Langerhans and the following medications:
Basiliximab 20 mg iv 2 hours before transplant and 20 mg iv 2 weeks post-transplant; Tacrolimus 1 mg p.o. bid adjusted to reach target trough levels of 3-6 ng/ml; Sirolimus 0.2 mg/kg loading dose, then 0.1 mg/kg p.o. daily adjusted to reach target trough levels of 10-15 ng/ml during the first 3 months post transplant and 7-10 ng/ml thereafter; Etanercept 50 mg iv 1 hour before transplant and 25 mg s.c. on days 3, 7,and 10 post-transplant; Exenatide 5-mcg s.c. bid for 1 week, then 10 mcg bid for 6 months after each transplant
|
|---|---|
|
Hypoglycemic Episodes by HYPO Score
First Tx Day 365
|
40.6 score on a scale
Interval 0.0 to 1234.0
|
|
Hypoglycemic Episodes by HYPO Score
Last Tx Day 365
|
18.7 score on a scale
Interval 0.0 to 1234.0
|
|
Hypoglycemic Episodes by HYPO Score
Baseline (pre-Tx)
|
266 score on a scale
Interval 2.0 to 1638.0
|
SECONDARY outcome
Timeframe: One year after the first and last transplantPopulation: ITT
%reduction in Ryan HYPO Score \[%(baseline score - 1-year post transplant score)/baseline\] at time of evaluation.
Outcome measures
| Measure |
Treatment
n=21 Participants
All subjects will receive up to 3 transplantations of allogeneic human islets of Langerhans.
Islets of Langerhans transplantation: Each subject may receive 1-3 transplantations of allogeneic human islets of Langerhans and the following medications:
Basiliximab 20 mg iv 2 hours before transplant and 20 mg iv 2 weeks post-transplant; Tacrolimus 1 mg p.o. bid adjusted to reach target trough levels of 3-6 ng/ml; Sirolimus 0.2 mg/kg loading dose, then 0.1 mg/kg p.o. daily adjusted to reach target trough levels of 10-15 ng/ml during the first 3 months post transplant and 7-10 ng/ml thereafter; Etanercept 50 mg iv 1 hour before transplant and 25 mg s.c. on days 3, 7,and 10 post-transplant; Exenatide 5-mcg s.c. bid for 1 week, then 10 mcg bid for 6 months after each transplant
|
|---|---|
|
Reduction in Hypoglycemic Severity Measured by %Reduction in HYPO Score
% Reduction from baseline to first tx day 365
|
66.1 percentage of HYPO baseline
Interval -300.0 to 100.0
|
|
Reduction in Hypoglycemic Severity Measured by %Reduction in HYPO Score
% Reduction from baseline to last tx day 365
|
90.1 percentage of HYPO baseline
Interval -106.0 to 100.0
|
Adverse Events
Treatment
Serious events: 11 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=21 participants at risk
All subjects will receive up to 3 transplantations of allogeneic human islets of Langerhans.
Islets of Langerhans transplantation: Each subject may receive 1-3 transplantations of allogeneic human islets of Langerhans and the following medications:
Basiliximab 20 mg iv 2 hours before transplant and 20 mg iv 2 weeks post-transplant; Tacrolimus 1 mg p.o. bid adjusted to reach target trough levels of 3-6 ng/ml; Sirolimus 0.2 mg/kg loading dose, then 0.1 mg/kg p.o. daily adjusted to reach target trough levels of 10-15 ng/ml during the first 3 months post transplant and 7-10 ng/ml thereafter; Etanercept 50 mg iv 1 hour before transplant and 25 mg s.c. on days 3, 7,and 10 post-transplant; Exenatide 5-mcg s.c. bid for 1 week, then 10 mcg bid for 6 months after each transplant
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
1/21 • Number of events 1 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
4.8%
1/21 • Number of events 1 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
4.8%
1/21 • Number of events 2 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.8%
1/21 • Number of events 1 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
4.8%
1/21 • Number of events 1 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Cardiac disorders
Myocardial ischaemia
|
4.8%
1/21 • Number of events 1 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Endocrine disorders
Hypoglycaemia
|
4.8%
1/21 • Number of events 1 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
General disorders
Asthenia
|
4.8%
1/21 • Number of events 1 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Hepatobiliary disorders
Cholecystitis
|
4.8%
1/21 • Number of events 1 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
4.8%
1/21 • Number of events 1 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Infections and infestations
Pneumonia
|
9.5%
2/21 • Number of events 2 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Infections and infestations
Pneumonia legionella
|
4.8%
1/21 • Number of events 1 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
4.8%
1/21 • Number of events 1 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
1/21 • Number of events 1 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
4.8%
1/21 • Number of events 1 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
Other adverse events
| Measure |
Treatment
n=21 participants at risk
All subjects will receive up to 3 transplantations of allogeneic human islets of Langerhans.
Islets of Langerhans transplantation: Each subject may receive 1-3 transplantations of allogeneic human islets of Langerhans and the following medications:
Basiliximab 20 mg iv 2 hours before transplant and 20 mg iv 2 weeks post-transplant; Tacrolimus 1 mg p.o. bid adjusted to reach target trough levels of 3-6 ng/ml; Sirolimus 0.2 mg/kg loading dose, then 0.1 mg/kg p.o. daily adjusted to reach target trough levels of 10-15 ng/ml during the first 3 months post transplant and 7-10 ng/ml thereafter; Etanercept 50 mg iv 1 hour before transplant and 25 mg s.c. on days 3, 7,and 10 post-transplant; Exenatide 5-mcg s.c. bid for 1 week, then 10 mcg bid for 6 months after each transplant
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
81.0%
17/21 • Number of events 23 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
General disorders
fatigue
|
76.2%
16/21 • Number of events 17 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Blood and lymphatic system disorders
anemia
|
71.4%
15/21 • Number of events 28 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
General disorders
asthenia
|
66.7%
14/21 • Number of events 16 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Skin and subcutaneous tissue disorders
acne
|
66.7%
14/21 • Number of events 18 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Nervous system disorders
Headache
|
57.1%
12/21 • Number of events 12 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
61.9%
13/21 • Number of events 17 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Investigations
Transaminases increased
|
47.6%
10/21 • Number of events 12 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Gastrointestinal disorders
diarrhea
|
61.9%
13/21 • Number of events 17 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
47.6%
10/21 • Number of events 11 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Blood and lymphatic system disorders
Leukopenia
|
28.6%
6/21 • Number of events 12 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Gastrointestinal disorders
Mouth ulceration
|
33.3%
7/21 • Number of events 10 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Gastrointestinal disorders
Stomatitis
|
38.1%
8/21 • Number of events 9 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
23.8%
5/21 • Number of events 7 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
7/21 • Number of events 7 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Injury, poisoning and procedural complications
Contusion
|
33.3%
7/21 • Number of events 7 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Investigations
Low density lipoprotein increased
|
23.8%
5/21 • Number of events 6 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
42.9%
9/21 • Number of events 16 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
33.3%
7/21 • Number of events 7 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
28.6%
6/21 • Number of events 8 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
42.9%
9/21 • Number of events 21 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Nervous system disorders
Dizziness
|
42.9%
9/21 • Number of events 9 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Nervous system disorders
Tremor
|
28.6%
6/21 • Number of events 7 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Psychiatric disorders
Insomnia
|
38.1%
8/21 • Number of events 8 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Renal and urinary disorders
Pollakiuria
|
28.6%
6/21 • Number of events 6 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Renal and urinary disorders
Nocturia
|
19.0%
4/21 • Number of events 5 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
38.1%
8/21 • Number of events 10 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
7/21 • Number of events 7 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
14.3%
3/21 • Number of events 3 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
28.6%
6/21 • Number of events 6 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
38.1%
8/21 • Number of events 8 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
|
Skin and subcutaneous tissue disorders
Rash
|
42.9%
9/21 • Number of events 10 • From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place