Pancreatic Islet Cell Transplantation - A Novel Approach to Improve Islet Quality and Engraftment

NCT00530686 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 008-095
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess a novel approach to immunosuppression in allogenic pancreatic islet cell transplant recipients. In addition, the study aims to assess remote site islet processing with culture for pancreatic islet cell transplantation in human subjects.

Conditions

Islet Cell Transplantation; Type 1 Diabetes

Keywords

Diabetes Mellitus; Hypoglycemia; Hyperglycemia; Type 1 Diabetes; Islet cell transplantation

Outcome Measures

Primary Outcomes (1)

• 1)Presence or absence of hypoglycemic unawareness 2) To assess incidence of hypoglycemic episodes 3) To assess insulin requirements in patients who did not become insulin independent.

  24 months

Secondary Outcomes (1)

• To assess the achievement of insulin independence at 12 month and 24 month post transplant in patients who underwent allo islet cell transplantation.

  12 months and 24 months

Interventions

Islet cell transplantation DRUG

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
• Patient is expected to receive an islet cell transplant (up to 3 infusions) for type I diabetes mellitus
• Type I diabetes mellitus of more than 5 years duration
• Age between 18 and 65
• Unstable diabetes mellitus control, as defined by glucose measurements above 200 mg/dL and/or below 80 mg/dL despite adequate medical care from a diabetology care team
• Hypoglycemia unawareness, as defined by episodes of loss of cognitive function; or the inability to recognize glucose levels below 50 mg/dL; or frequent episodes of symptomatic hypoglycemia; or admission to the hospital for hypo/hyperglycemic
• Incapacitating signs and symptoms, as defined by the referring physician
• HbA1c \> 6.5
• 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
• Patient has a known hypersensitivity to Tacrolimus, sirolimus, dacluzimab, or CellCept
• Patient is pregnant or lactating
• 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
• Glofil or Creatinine Clearance \< 60 mL/min
• Serum Creatinine \> 1.6 mg/dL consistently
• Body mass index \> 28
• Malignancy other than basal cell carcinoma or squamous cell carcinoma
• 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
• Basal C-Peptide \> 0.3 ng/dL

Sponsors & Collaborators

• Baylor Research Institute: lead
• Baylor Health Care System: collaborator

Study Sites (1)

Annette C. & Harold C. Simmons Transplant Institute - Baylor University Medical Center, Dallas Texas, USA - Baylor All Saints Medical Center, Fort Worth Texas, USA

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 Officials

• Nicholas Onaca, MD

  Baylor Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 13, 2007
• First Posted: September 17, 2007
• Study Start: July 1, 2008
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 24, 2017

Record last verified: 2017-04

Locations

US (1)