Pancreatic Islet Cell Transplantation

NCT00214786 | Completed Phase 1 Results DMC

• 1 other identifier: 003-040
• Study Type: interventional
• Target: 4
• 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

Type 1 Diabetes

Keywords

Diabetes Mellitus; Hypoglycemia; Hyperglycemia

Outcome Measures

Primary Outcomes (1)

• Achievement of Insulin Independence at 12-month Post Transplant

  To assess the number of patients who achieve insulin independence at 12-month after islet cell transplantation

  12 months post transplant

Secondary Outcomes (9)

• Presence or Absence of Hypoglycemic Unawareness

  12 months after transplantation

• Incidence of Hypoglycemic Episodes

  12 months after transplantation

• Change of Insulin Requirements in Patients Who Did Not Become Insulin Independent

  12 months after transplantation

• Islet Cell Mass Obtained After Remote Site Processing

  At transplantation

• The Number of Islet Cell Infusions Needed to Achieve Insulin Independence

  12 months after transplantation

Study Arms (1)

Islet Cell Transplantation

EXPERIMENTAL

Allogenic islet cell transplantation

Biological: Islet cell transplantation

Interventions

Islet cell transplantation BIOLOGICAL

Allogenic islet transplantation

Islet Cell 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:

• Patient has been fully informed and has signed an Institutional Review Board (IRB) approved informed consent form and is willing and able to follow study procedures for the full 2 years
• Patient is expected to receive an islet cell transplant (up to 3 infusions) for type I diabetes mellitus
• Type I diabetes 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
• Hypoglycemia unawareness, as defined by episodes of loss of cognitive function
• Incapacitating signs and symptoms, as defined by the referring physician
• Poor control of HbA1c \> 8%
• 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:

• Patients meeting any of the following criteria will be excluded from study participation.
• Patient has previously received or is receiving an organ or bone marrow transplant
• Patient has a known hypersensitivity to Tacrolimus, sirolimus, daclizumab, 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
• Glomerular filtration rate (GLOFIL) \< 60 mL/min
• Serum Creatinine \> 1.6 mg/dL consistently
• Body mass index \> 30
• Autoimmune thyroiditis
• Malignancy other than basal cell carcinoma or squamous cell carcinoma
• Radiographic evidence of pulmonary infection
• Evidence of liver disease
• Portal hypertension
• Active infections

Sponsors & Collaborators

• Baylor Research Institute: lead
• Baylor Health Care System: collaborator
• University of Miami: collaborator

Study Sites (1)

Baylor Regional Transplant Institute - 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

Limitations and Caveats

Three of the four patients voluntarily withdrew from the study.

Results Point of Contact

• Title: Dr. Marlon Levy
• Organization: Baylor University Medical Center

Marlon.Levy@baylorhealth.edu

214-820-2050

Study Officials

• Marlon Levy, MD

  Baylor Regional Transplant Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: September 14, 2005
• First Posted: September 22, 2005
• Study Start: April 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: June 14, 2017
• Results First Posted: June 6, 2014

Record last verified: 2017-06

Locations

US (1)