Pancreatic Islet Transplantation Into the Gastric Submucosa

NCT01571817 | Completed Phase 1

• 1 other identifier: Islet-Tx-Sub-DERC
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes

Keywords

Insulin Dependent

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Hypo- and Hyper-glycemia limits for blood glucose related risks; during procedure, abdominal pain, duodenal hemorrhage, and duodenal perforation post-procedure, fever, cytokine release syndrome (to the thymoglobulin), immunosuppression related issues

  Six months

Study Arms (1)

Study intervention

EXPERIMENTAL

endoscopically-guided intestinal submucosal transplantation of Isolated Human Pancreatic Islets in a type 1 diabetic patient

Biological: Isolated Human Pancreatic Islets

Interventions

Isolated Human Pancreatic Islets BIOLOGICAL

Study intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Must be able to give written informed consent
• 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
• Active infections

Sponsors & Collaborators

• Andrew Posselt: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Andrew M Posselt, M.D., Ph.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 5, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 8, 2020

Record last verified: 2020-08

Locations

US (1)