Pancreatic Islet Cell Transplantation After Kidney Transplantation - A Novel Approach to Immunosupression

NCT03047200 | Withdrawn Phase 1 DMC

• 1 other identifier: 008-189
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to further test islet cell transplant in patients who have had a kidney transplant. This study will also evaluate the safety and effectiveness of the anti-rejection medications used to prevent rejection after your islet cell transplant.

Conditions

Islet Cell Transplantation; Type 1 Diabetes

Keywords

Diabetes Mellitus; Hypoglycemia; Hyperglycemia; Type 1 Diabetes; Islet Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Restoration of sustained euglycemia without exogenous insulin or with reduced insulin dosage in patients who underwent pancreatic islet cell after kidney transplantation

  Categorical variables will be analyzed using McNemar's test. Continuous data will be analyzed using repeated measures analysis of variance and Friedman's test when the normality assumption is violated. Follow-up pairwise comparisons will be performed using the Bonferroni multiple comparisons procedure at the 0.05 level of significance. Kaplan Meier estimates for patient and graft survival will be used.

  24 months

Secondary Outcomes (3)

• To assess incidence of hypoglycemic episodes

  24 months

• To monitor insulin requirements in patients who did not achieve insulin independence

  24 months

• To assess total islet mass needed to achieve sustained euglycemia with or without exogenous insulin.

  24 months

Interventions

Islet cell transplantation BIOLOGICAL

The process is based on the enzymatic isolation of the pancreatic islets of Langerhans from an organ procured from a cadaveric donor; the islets obtained are injected into the liver of the recipient via percutaneous catheterization of the portal venous system . This procedure allows the selective transplantation of the insulin-producing cell population avoiding open surgery as well as the transplantation of the duodenum and the exocrine pancreas and their related morbidity.

Eligibility Criteria

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

You may qualify if:

• Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures for the full 24 months.
• Type 1 diabetes mellitus of more than 5 years duration
• Age between 18 and 65
• Unstable diabetes mellitus control despite expert management by a diabetology care team for at least 6 months prior to consideration for transplantation as defined by the following:
• During the past six months (or during the period of intensive diabetes care): Any episodes of hypoglycemic unawareness, as defined by the inability to recognize glucose levels below 50 mg/dL; or episodes of loss of cognitive function; or frequent episodes of symptomatic hypoglycemia; or admission to the hospital for hypo- or hyperglycemia; and
• HbA1C\>6.5%.
• Patient underwent kidney transplantation at least six months before enrollment, and has stable kidney allograft function, defined as creatinine levels of maximum 2 mg/dl, stable renal allograft function as assessed by the transplant nephrologist, and has a creatinine clearance of more than 40 ml/min.
• Psychogenically able to comply, in the opinion of the investigator
• Female patients of childbearing potential must have a negative urine or serum pregnancy test upon hospitalization or within 7 days prior to enrollment and have agreed to utilize effective birth control throughout the study as well as for 6 weeks following study completion

You may not qualify if:

• Patient has previously received or is receiving an organ or bone marrow transplant other than a first kidney transplant.
• \. Patient has a known hypersensitivity to Tacrolimus, Sirolimus, Alemtuzumab, or Mycophenolate (allow substitution of Myfortic for CellCept).
• \. Patient is pregnant or lactating (must provide effective contraception method).
• \. Patient has participated in a blinded trial or participated in a trial involving a non-marketed (investigational) drug within 3 months of enrollment.
• \. Patient has participated in a trial involving a marketed drug or an infusion device within 30 days of the start of the trial.
• \. Patient exhibits any one of the following clinical criteria:
• Creatinine clearance or Glofil test \< 40 mL/min
• Serum creatinine \> 2.0 mg/dL consistently, or more than 0.2 mg/dl increase in creatinine over the last five months
• Body mass index \> 28
• Malignancy other than BCC and SCC
• Radiographic evidence of pulmonary infection
• Evidence of liver disease as evidenced by \>2X ULN for AST, ALT, Alk. Phos., or T. bili.
• Active infections
• Hypercoagulable states (history of recurrent venous thrombosis, defined thrombophilia)
• Bleeding / coagulation disorders

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Hypoglycemia; Hyperglycemia

Interventions

Islets of Langerhans Transplantation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: February 8, 2017
• Study Start: July 1, 2008
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: February 15, 2017

Record last verified: 2017-02

Locations

US (1)