Pancreatic Islet Transplantation Into the Gastric Submucosa
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ClinicalTrials.gov Identifier: NCT01571817
Recruitment Status : Unknown
Verified August 2013 by University of California, San Francisco. Recruitment status was: Enrolling by invitation
The overall objective of this pilot project is to evaluate the safety and efficacy of the gastric submucosal space as a novel site for clinical islet transplantation. The site has several physiologic attributes that may improve the outcomes of islet transplantation compared with the conventional intraportal transplant site.
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Ages Eligible for Study:
18 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Key Inclusion Criteria:
Primary islet allotransplant
Type I diabetes mellitus for a minimum of 5 years
One or more of the following signs or symptoms despite intensive efforts made in close cooperation with their diabetic care team:
Metabolic lability/instability characterized by hypoglycemia or ketoacidosis (>2 hospital admissions in the previous year), erratic glucose profiles (MAGE>120 mg/dL), or disruption in lifestyle of 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 the diabetes care team)
Progressive secondary complications as defined by (i) a new proliferative retinopathy or clinically significant macular edema or therapy with photocoagulation during the last year; or (ii) symptomatic autonomic neuropathy (as defined by postural hypotension or neuropathic bladder)
Age 18 and older
Patients who have a renal transplant must have received their transplant at least 3 months previously and must have stable renal function (see exclusion criteria below)
Must be able to give written informed consent
Key Exclusion Criteria:
Lymphopenia (<1000/µL) or leukopenia ( <3000 total leukocytes/µL)
Presence of panel-reactive anti-HLA antibody >20%
Positive lymphocytotoxic cross-match using donor lymphocytes and serum
Evidence of acute EBV infection (IgM>IgG) OR no serologic evidence of previous exposure to EBV (IgG>IgM)
Calculated or measured GFR < 50 ml/min/m2 in patients without a renal transplant.
Calculated or measured GFR < 40 ml/min/m2 in patients with a renal transplant.
Portal hypertension or history of significant liver disease
History of malignancy within 10 years (except for treated basal or squamous cell CA of the skin)
Active peptic ulcer disease or other gastric mucosal abnormalities as identified on screening endoscopy
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 who are sexually active but not using an acceptable method of contraception
Serologic evidence of infection with HIV, or HbsAg or HCV Ab positive
Major ongoing psychiatric illness
Ongoing substance abuse, drug or alcohol; or recent history of noncompliance
Any condition that in the opinion of the Principal Investigator does not allow safe participation in the study