Trial Outcomes & Findings for Allogeneic Islet Cells Transplanted Onto the Omentum (NCT NCT02213003)
NCT ID: NCT02213003
Last Updated: 2025-08-12
Results Overview
Composite outcome measured by the proportion of subjects with HbA1c level of \</= 6.5 % and free of severe hypoglycemic events after omentum islet transplant
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
3 participants
Primary outcome timeframe
From day 28 to day 365 after omentum islet transplant
Results posted on
2025-08-12
Participant Flow
Participant milestones
| Measure |
Islet Transplantation.
Transplantation of at least 5000 islet equivalents/kg of body weight onto the omentum.
Islet transplantation: Transplantation of at least 5000 islet equivalents/kg of body weight onto the Omentum.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Allogeneic Islet Cells Transplanted Onto the Omentum
Baseline characteristics by cohort
| Measure |
Islet Transplantation
n=3 Participants
Transplantation of at least 5000 islet equivalents/kg of body weight onto the omentum.
Islet transplantation: Transplantation of at least 5000 islet equivalents/kg of body weight onto the Omentum.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
|
Number of participants with Severe Hypoglycemia in the Past 12 Months and HbA1c < 10%
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From day 28 to day 365 after omentum islet transplantComposite outcome measured by the proportion of subjects with HbA1c level of \</= 6.5 % and free of severe hypoglycemic events after omentum islet transplant
Outcome measures
| Measure |
Islet Transplantation.
n=3 Participants
Transplantation of at least 5000 islet equivalents/kg of body weight onto the omentum.
Islet transplantation: Transplantation of at least 5000 islet equivalents/kg of body weight onto the Omentum.
|
|---|---|
|
A1c </= 6.5% and no Severe Hypoglycemia
|
0.667 Proportion of participants
|
PRIMARY outcome
Timeframe: From day 28 to day 365 after omentum islet transplantSafety outcome. Post-procedural complications included were: Bleeding, wound infection, hernia, torsion of omentum, gastrointestinal obstruction, abscess, cysts, and need for surgical intervention. Measured by the count of participants with procedural complications.
Outcome measures
| Measure |
Islet Transplantation.
n=3 Participants
Transplantation of at least 5000 islet equivalents/kg of body weight onto the omentum.
Islet transplantation: Transplantation of at least 5000 islet equivalents/kg of body weight onto the Omentum.
|
|---|---|
|
Procedural Complications
|
3 Participants
|
Adverse Events
Islet Transplantation
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Islet Transplantation
n=3 participants at risk
Transplantation of at least 5000 islet equivalents/kg of body weight onto the omentum.
Islet transplantation: Transplantation of at least 5000 islet equivalents/kg of body weight onto the Omentum.
|
|---|---|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
1/3 • Number of events 1 • From day 28 to day 365 after omentum islet transplant
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
100.0%
3/3 • Number of events 3 • From day 28 to day 365 after omentum islet transplant
|
|
Metabolism and nutrition disorders
Weight Loss
|
66.7%
2/3 • Number of events 2 • From day 28 to day 365 after omentum islet transplant
|
|
Skin and subcutaneous tissue disorders
Hair Loss
|
66.7%
2/3 • Number of events 2 • From day 28 to day 365 after omentum islet transplant
|
|
Blood and lymphatic system disorders
Anemia/Low Hemoglobin
|
66.7%
2/3 • Number of events 2 • From day 28 to day 365 after omentum islet transplant
|
|
Gastrointestinal disorders
Left Parotid Glad Inflammation
|
33.3%
1/3 • Number of events 1 • From day 28 to day 365 after omentum islet transplant
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
33.3%
1/3 • Number of events 1 • From day 28 to day 365 after omentum islet transplant
|
|
Musculoskeletal and connective tissue disorders
Left Achilles Tendonitis
|
33.3%
1/3 • Number of events 1 • From day 28 to day 365 after omentum islet transplant
|
|
Musculoskeletal and connective tissue disorders
Stress fracture to the non-weight bearing portion of the left calcaneus
|
33.3%
1/3 • Number of events 1 • From day 28 to day 365 after omentum islet transplant
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • Number of events 1 • From day 28 to day 365 after omentum islet transplant
|
|
Cardiac disorders
Tachycardia
|
33.3%
1/3 • Number of events 1 • From day 28 to day 365 after omentum islet transplant
|
|
Immune system disorders
Hypersensitivity reaction to Thymoglobulin
|
33.3%
1/3 • Number of events 1 • From day 28 to day 365 after omentum islet transplant
|
|
Renal and urinary disorders
Macroscopic Hematuria
|
33.3%
1/3 • Number of events 1 • From day 28 to day 365 after omentum islet transplant
|
|
Respiratory, thoracic and mediastinal disorders
Viral Bronchitis
|
33.3%
1/3 • Number of events 1 • From day 28 to day 365 after omentum islet transplant
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory Infection
|
33.3%
1/3 • Number of events 1 • From day 28 to day 365 after omentum islet transplant
|
|
Nervous system disorders
Seizure-Like Episode
|
33.3%
1/3 • Number of events 1 • From day 28 to day 365 after omentum islet transplant
|
|
Gastrointestinal disorders
Nausea and Vomiting
|
33.3%
1/3 • Number of events 1 • From day 28 to day 365 after omentum islet transplant
|
|
Reproductive system and breast disorders
Laparoscopic removal of displaced intrauterine device and bilateral tubal ligation
|
33.3%
1/3 • Number of events 1 • From day 28 to day 365 after omentum islet transplant
|
|
Endocrine disorders
Severe Hypoglycemia
|
33.3%
1/3 • Number of events 1 • From day 28 to day 365 after omentum islet transplant
|
Additional Information
Rodolfo Alejandro, MD
Diabetes Research Institute/University of Miami
Phone: 305-243-3389
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place