Allogeneic Islet Cells Transplanted Onto the Omentum

NCT02213003 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 20140144
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Type 1 Diabetes Mellitus; Hypoglycemia; Hypoglycemia Unawareness

Keywords

islet transplantation

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  From day 28 to day 365 after omentum islet transplant

Study Arms (1)

Islet transplantation

EXPERIMENTAL

Transplantation of at least 5000 islet equivalents/kg of body weight onto the omentum.

Biological: Islet transplantation

Interventions

Islet transplantation BIOLOGICAL

Transplantation of at least 5000 islet equivalents/kg of body weight onto the Omentum.

Islet transplantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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).
• 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).

Sponsors & Collaborators

• Rodolfo Alejandro: lead
• Juvenile Diabetes Research Foundation: collaborator
• Diabetes Research Institute Foundation: collaborator

Study Sites (1)

Diabetes Research Institute, University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Interventions

Islets of Langerhans Transplantation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Endocrine Surgical Procedures; Surgical Procedures, Operative; Transplantation

Results Point of Contact

• Title: Rodolfo Alejandro, MD
• Organization: Diabetes Research Institute/University of Miami

Ralejand@med.miami.edu

305-243-3389

Study Officials

• Rodolfo Alejandro

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 11, 2014
• Study Start: September 1, 2014
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 12, 2025
• Results First Posted: August 12, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)