Prevention of Autoimmune Destruction and Rejection of Human Pancreatic Islets Following Transplantation for Insulin Dependent Diabetes Mellitus

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT00501709
• Collaborator: Juvenile Diabetes Research Foundation (Other)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 118
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Pancreatic islets are the part of the pancreas that produce insulin and help control the blood sugar. This study aims to improve islet transplantation as a treatment for Type 1 Diabetes by using a new combination of immunosuppressive drugs that have been successful in treating other autoimmune diseases and in preventing kidney transplant rejection.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes	Drug: Belatacept and Raptiva	Phase 1/Phase 2

Detailed Description

The primary objective of these studies is to assess the efficacy and safety of allogeneic pancreatic islet transplantation in the treatment of type I diabetes mellitus. A secondary study objective is to evaluate the efficacy of various immunosuppressive protocols and agents in preventing autoimmune destruction and rejection of allogeneic islet transplants. A tertiary objective is to determine the safety and efficacy of allogeneic pancreatic islet transplantation in patients who have received another organ transplant such as a kidney or liver.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prevention of Autoimmune Destruction and Rejection of Human Pancreatic Islets Following Transplantation for Insulin Dependent Diabetes Mellitus
• Actual Study Start Date: Feb 1, 2007
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Allogenic pancreatic islet transplant using belatacept and raptiva	Drug: Belatacept and Raptiva; immunosuppressant agent to prevent rejection in transplant recipients; Other Names: immunosuppressant

Outcome Measures

Primary Outcome Measures

1. lnsulin independence [monthly]

   improved glycemic control

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Type 1 Diabetes

• Metabolic lability/instability characterized by hypoglycemia or ketoacidosis(>2 hospital admissions in the previous year), erratic glucose profiles(MAGE >120mg/dL), or disruption in lifestyle(danger to life, self or others). Reduced awareness of hypoglycemia or > 1 episode in the last 1.5 years of severe hypoglycemia.

• Persistently poor glucose control (as defined by HgbA1c>10% at the end of six months of intensive management efforts with diabetes care team.

• Progressive secondary complications as defined by

• a new diagnosis by an ophthalmologist of proliferative retinopathy or clinically significant macular edema or therapy with photocoagulation during the last year; or

• urinary albumin excretion rate >300mg/day but proteinuria <3g/day; or

• symptomatic autonomic neuropathy (as defined by postural hypotension in the setting of euvolemia, gastroparesis or diarrhea attributed to diabetic neuropathy, or neuropathic bladder as diagnosed by an urologist)

Exclusion Criteria:

• Patient weighs more than 80kg or body mass index BMI>28

• Patient's insulin requirement is >55 Units/day.

• Current use of immunosuppressive agents.

• History of malignancy within 10 years (except for adequately treated basal or squamous cell CA of the skin).

• Active peptic ulcer disease.

• Severe unremitting diarrhea or other GI disorders potentially interfering with the ability to absorb oral medications.

• Untreated proliferative retinopathy.

• Pregnancy or breastfeeding.

• Female subjects not post-menopausal or surgically sterile, or not using an acceptable method or contraception.

• Active infections.

• Major ongoing psychiatric illness.

• Ongoing substance abuse, drug or alcohol; or recent history of noncompliance.

• Portal hypertension or history of significant liver disease.

• Lymphopenia (<1000/ul) or leukopenia (<3000 total leukocytes/ul) or an absolute CD4 count <500/ul.

• Presence or history of panel-reactive anti-HLA antibody >20%.

• Evidence of acute EBV infection (IgM>IgG) OR no serologic evidence of previous exposure to EBV (IgG>IgM).

• Serologic evidence of infection with HIV or HbsAg or HCV Ab positive.

• Creatinine clearance <60ml/min/m2.

• Positive lymphocytoxic cross-match using donor lymphocytes and serum

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94143

Sponsors and Collaborators

• University of California, San Francisco
• Juvenile Diabetes Research Foundation

Investigators

• Principal Investigator: Peter G Stock, M.D., Ph.D., University of California, San Francisco
• Principal Investigator: Andrew Posselt, M.D., Ph.D., University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT00501709
• Other Study ID Numbers: 39-42C
• First Posted: Jul 16, 2007
• Last Update Posted: May 6, 2020
• Last Verified: Apr 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Abatacept; Immunosuppressive Agents

Study Results

No Results Posted as of May 6, 2020