Type 1 Diabetes MellitusPhase 1/2NCT02213003
Allogeneic Islet Cells Transplanted Onto the Omentum
A Phase 1/2 study testing Islet transplantation in people with Type 1 Diabetes Mellitus and Hypoglycemia, run by Rodolfo Alejandro at 1 site in United States.
Trial summary
Current islet transplantation into the portal vein of the liver has shown the unique ability of islets to stabilize blood glucose levels and prevent severe hypoglycemia in a selected group of subjects with Type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Hypoglycemia, Hypoglycemia Unawareness
- What is being tested?
- Islet transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 30 Jun 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients age 18 to 65 years of age.
- Ability to provide written informed consent.
- Mentally stable and able to comply with the procedures of the study protocol.
- Type1 diabetes with onset of disease at <40 years of age, insulin-dependence for > 5 years at the time of enrollment
- Absent stimulated c-peptide (<0.3ng/mL) in response to a mixed meal tolerance test.
- Involvement in intensive diabetes management
Show all 9Show fewer
- At least one episode of severe hypoglycemia in the 12 months prior to study enrollment.
- Reduced awareness of hypoglycemia as defined by a Clarke score of 4 or more OR A Hypoglycemia score greater than or equal to the 90th percentile (1047) during the screening period; OR Marked glycemic lability and defined by a lability index score greater than or equal to the 90th percentile (433 mmol/L2/h•wk-1) during the screening period; OR A composite of a Clarke score of 3 or less and a hypoglycemia score greater than or equal to the 75th percentile (423) and a lability index greater than or equal to the 75th percentile (329) during the screening period.
- Subjects screening data from 20053135 protocol will be accepted for subjects eligible for this study. If 20053135 visit was 12 months prior to enrollment, Visit 2 laboratory should be repeated.
Who cannot join
- Body Mass Index (BMI) >30 kg/m2 or patient weight ≤50 kg.
- Insulin requirement of >1.0 IU/kg/day or <15 U/day.
- HbA1c >10%.
- Untreated proliferative diabetic retinopathy.
- Blood Pressure: SBP >160 mmHg or DBP >100 mmHg.
- Glomerular filtration rate <80 mL/min/1.73 m2 (calculated).
Show all 30Show fewer
- Presence or history of macroalbuminuria (>300mg/g creatinine).
- Presence or history of panel-reactive anti-HLA antibodies.
- For female subjects: Serum or urine Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation. For male subjects: intent to procreate during the duration of the study or within 4 months after discontinuation or unwillingness to use effective measures of contraception. If sexually active, subject must use at least two medically accepted methods of birth control.
- Presence or history of active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB).
- Negative screen for Epstein-Barr Virus (EBV) by IgG determination.
- Invasive aspergillus, histoplasmosis, and coccidioidomycosis infection within one year prior to study enrollment.
- Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin.
- Active alcohol or substance abuse.
- Hb below the lower limits of normal at the local laboratory; lymphopenia (<1,000/µL), neutropenia (<1,500/µL), or thrombocytopenia (platelets <100,000/µL).
- A history of Factor V deficiency.
- Any coagulopathy or medical condition requiring long-term anticoagulant therapy.
- Severe co-existing cardiac disease,
- recent myocardial infarction (within past 6 months)
- evidence of ischemia on functional cardiac exam within the last year) left ventricular ejection fraction <30%.
- Persistent elevation of liver function tests at the time of study entry.
- Symptomatic cholecystolithiasis.
- Acute or chronic pancreatitis.
- Symptomatic peptic ulcer disease.
- Gastrointestinal disorders potentially interfering with the ability to absorb oral medications.
- Hyperlipidemia despite medical therapy (fasting LDL cholesterol > 130 mg/dL, fasting triglycerides > 200 mg/dl).
- Chronic use of systemic steroids, except for the use of ≤5 mg prednisone daily, or an equivalent dose of hydrocortisone, for physiological replacement only.
- Treatment with any anti-diabetic medications other than insulin within 4 weeks of enrollment.
- 23. Use of any investigational agents within 4 weeks of enrollment. 24. Administration of live attenuated vaccine(s) within 2 months of enrollment. 25. Any medical condition that, in the opinion of the investigator, will interfere with the safe participation in the trial.
- 26. Treatment with any immunosuppressive regimen at the time of enrollment. 27. A previous islet transplant. 28. A previous pancreas transplant 29. Inflammatory bowel disease. 30. History of intestinal obstructions. 31. Previous major abdominal surgery. 32. History of peritonitis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Diabetes Research Institute, University of Miami Miller School of Medicine
Miami, Florida, 33136
About this study
Current islet transplantation into the portal vein of the liver has shown the unique ability of islets to stabilize blood glucose levels and prevent severe hypoglycemia in a selected group of subjects with Type 1 diabetes. The main limitations of islet transplantation are the need for systemic immunosuppression to maintain function and the loss of islet function over time. Additionally, many studies have demonstrated that the current site of transplantation in the liver is not an ideal site due to several factors. These factors include (1) significant liver inflammation following islet infusion; (2) potential for life-threatening procedure-related complications such as bleeding and thrombosis; (3) high levels of immunosuppressive drugs and GI toxins in the liver contributing to islet toxicity; (4) the inability to retrieve islets after infusion; and (5) development of graft dysfunction in a number of recipients of intrahepatic allogeneic and autologous islets. The implantation of islets into the omentum will allow adequate engraftment of islets onto the omentum and will lead to comparable or superior functional and clinical outcomes than in the traditional intrahepatic site.
Read the detailed description
Islet transplantation will be performed in subjects with unstable Type 1 diabetes mellitus under permanent immunosuppression. Islets are re-suspended in autologous plasma and distributed on the omental surface by a minimal invasive approach. Cell adherence is achieved by addition of clinical-grade recombinant human thrombin that reacts with plasma to create a biocompatible, degradable gel containing the islet graft. The primary efficacy endpoint is the proportion of subjects with HbA1c ≤6.5% at 1 year AND free of severe hypoglycemic events from Day 28 to Day 365, inclusive, after the islet transplant. The primary safety endpoint is to demonstrate patient safety throughout all stages of the trial.
- Being tested
- Islet transplantation
- Keywords
- islet transplantation
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Islet transplantationBiological
Transplantation of at least 5000 islet equivalents/kg of body weight onto the Omentum.
| Study group | Role | What they receive |
|---|---|---|
| Islet transplantation | Experimental | Transplantation of at least 5000 islet equivalents/kg of body weight onto the omentum. Receives: Biological: Islet transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
A1c </= 6.5% and no Severe Hypoglycemia
Composite outcome measured by the proportion of subjects with HbA1c level of </= 6.5 % and free of severe hypoglycemic events after omentum islet transplant
Measured: From day 28 to day 365 after omentum islet transplant
Procedural Complications
Safety 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.
Measured: From day 28 to day 365 after omentum islet transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study startSep 2014
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rodolfo Alejandro
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Diabetes Research Institute Foundation
- Responsible party
- Sponsor-investigator, Rodolfo Alejandro, University of Miami
- Investigators
- Rodolfo Alejandro, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213003
- Sponsor's protocol ID
- 20140144
- Status last verified
- Jul 2025
- First submitted
- 7 Aug 2014
- Last updated
- 12 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: undecided. This is a small phase 1/2 pilot trial.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Islet Cells Transplanted Onto the Omentum
- ClinicalTrials.gov ID
- NCT02213003
- Acronym / sponsor ID
- 20140144
- Keywords
- islet transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Rodolfo AlejandroUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Diabetes Research Institute Foundation
- Study start
- Sep 2014 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 11 Aug 2014 (estimated)
- Results
- Posted 12 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Current islet transplantation into the portal vein of the liver has shown the unique ability of islets to stabilize blood glucose levels and prevent severe hypoglycemia in a selected group of subjects with Type 1 diabetes. The main limitations of islet transplantation are the need for systemic immunosuppression to maintain function and the loss of islet function over time. Additionally, many studies have demonstrated that the current site of transplantation in the liver is not an ideal site due to several factors. These factors include (1) significant liver inflammation following islet infusion; (2) potential for life-threatening procedure-related complications such as bleeding and thrombosis; (3) high levels of immunosuppressive drugs and GI toxins in the liver contributing to islet toxicity; (4) the inability to retrieve islets after infusion; and (5) development of graft dysfunction in a number of recipients of intrahepatic allogeneic and autologous islets. The implantation of islets into the omentum will allow adequate engraftment of islets onto the omentum and will lead to comparable or superior functional and clinical outcomes than in the traditional intrahepatic site.
Detailed description
Islet transplantation will be performed in subjects with unstable Type 1 diabetes mellitus under permanent immunosuppression. Islets are re-suspended in autologous plasma and distributed on the omental surface by a minimal invasive approach. Cell adherence is achieved by addition of clinical-grade recombinant human thrombin that reacts with plasma to create a biocompatible, degradable gel containing the islet graft. The primary efficacy endpoint is the proportion of subjects with HbA1c ≤6.5% at 1 year AND free of severe hypoglycemic events from Day 28 to Day 365, inclusive, after the islet transplant. The primary safety endpoint is to demonstrate patient safety throughout all stages of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Islet transplantation | Experimental | Biological: Islet transplantationTransplantation of at least 5000 islet equivalents/kg of body weight onto the omentum. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female patients age 18 to 65 years of age.
- Ability to provide written informed consent.
- Mentally stable and able to comply with the procedures of the study protocol.
- Type1 diabetes with onset of disease at <40 years of age, insulin-dependence for > 5 years at the time of enrollment
- Absent stimulated c-peptide (<0.3ng/mL) in response to a mixed meal tolerance test.
Key exclusion criteria (30 listed)
- Body Mass Index (BMI) >30 kg/m2 or patient weight ≤50 kg.
- Insulin requirement of >1.0 IU/kg/day or <15 U/day.
- HbA1c >10%.
- Untreated proliferative diabetic retinopathy.
- Blood Pressure: SBP >160 mmHg or DBP >100 mmHg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Islet transplantationTransplantation of at least 5000 islet equivalents/kg of body weight onto the Omentum. | Biological | Islet transplantation |
Primary outcome
A1c </= 6.5% and no Severe Hypoglycemia
Time frame: From day 28 to day 365 after omentum islet transplant
Composite outcome measured by the proportion of subjects with HbA1c level of </= 6.5 % and free of severe hypoglycemic events after omentum islet transplant
Procedural Complications
Time frame: From day 28 to day 365 after omentum islet transplant
Safety 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. undecided. This is a small phase 1/2 pilot trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodolfo Alejandro principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Islet transplantation in people with Type 1 Diabetes Mellitus and Hypoglycemia, run by Rodolfo Alejandro at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A1c </= 6.5% and no Severe Hypoglycemia (time frame: From day 28 to day 365 after omentum islet transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.