Trial Outcomes & Findings for A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients (NCT NCT01897688)
NCT ID: NCT01897688
Last Updated: 2026-06-18
Results Overview
Number of participants free of severe hypoglycemic events
COMPLETED
PHASE3
10 participants
Two years after the final islet transplant.
2026-06-18
Participant Flow
105 potential participants have screened for this study, and 10 have enrolled in the study after completing all screening procedures. 2 patients were transplanted
105 potential participants have screened for this study, and 10 have enrolled in the study after completing all screening procedures. 2 patients were transplanted
Participant milestones
| Measure |
Islet Cell Transplant
All qualified subjects will be put on United Network for Organ Sharing (UNOS) Islet Transplant wait list for potential islet cell transplant.
Islet Cell Transplant
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Islet Cell Transplant
All qualified subjects will be put on United Network for Organ Sharing (UNOS) Islet Transplant wait list for potential islet cell transplant.
Islet Cell Transplant
|
|---|---|
|
Overall Study
PATIENT NOT TRANSPLANTED
|
8
|
Baseline Characteristics
A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients
Baseline characteristics by cohort
| Measure |
Islet Cell Transplant
n=10 Participants
All qualified subjects will be put on United Network for Organ Sharing (UNOS) Islet Transplant wait list for potential islet cell transplant.
Islet Cell Transplant
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
White
|
4 participants
n=20 Participants
|
|
Race/Ethnicity, Customized
White, Non Hispanic
|
6 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Two years after the final islet transplant.Number of participants free of severe hypoglycemic events
Outcome measures
| Measure |
Islet Cell Transplant
n=2 Participants
All qualified subjects will be put on United Network for Organ Sharing (UNOS) Islet Transplant wait list for potential islet cell transplant.
Islet Cell Transplant
|
|---|---|
|
Safety and Feasibility of Islet Transplantation to Treat Type-1 Diabetes (T1D)
|
2 participants
|
Adverse Events
Islet Cell Transplant
Serious adverse events
| Measure |
Islet Cell Transplant
n=10 participants at risk
10 have enrolled in the study after completing all screening procedures.
|
|---|---|
|
Immune system disorders
Anti Donor Alloantibodies
|
0.00%
0/10 • 24 months
|
|
Blood and lymphatic system disorders
Cytopenias
|
0.00%
0/10 • 24 months
|
|
Immune system disorders
Opportunistic Infections
|
0.00%
0/10 • 24 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place