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Pancreatic Islet Transplantation Into the Gastric Submucosa | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Pancreatic Islet Transplantation Into the Gastric Submucosa

Treatment of Type I Diabetes by Pancreatic Islet Transplantation Into The Gastric Submucosa

NCT01571817•Andrew Posselt

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.

Detailed Description

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. Safety will be evaluated by the monitoring of side effects such as post procedural GI complications, frequency of hypo and hyperglycemic events, and immunosuppression side effects. Efficacy will be determined by accepted measures including insulin independence, long term glucose control, and reduction/elimination of hypoglycemic events. The site has several physiologic attributes that may improve the outcomes of islet transplantation compared with the conventional intraportal transplant site.

Eligibility

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Primary islet allotransplant
•2. Type I diabetes mellitus for a minimum of 5 years
•3. 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)
•4. Age 18 and older

Exclusion Criteria

•6. Must be able to give written informed consent
•1. Lymphopenia (\<1000/µL) or leukopenia ( \<3000 total leukocytes/µL)
•2. Presence of panel-reactive anti-HLA antibody \>20%
•3. Positive lymphocytotoxic cross-match using donor lymphocytes and serum
•4. Evidence of acute EBV infection (IgM\>IgG) OR no serologic evidence of previous exposure to EBV (IgG\>IgM)
•5. Calculated or measured GFR \< 50 ml/min/m2 in patients without a renal transplant.
•6. Calculated or measured GFR \< 40 ml/min/m2 in patients with a renal transplant.
•7. Portal hypertension or history of significant liver disease
•8. History of malignancy within 10 years (except for treated basal or squamous cell CA of the skin)
•9. Active peptic ulcer disease or other gastric mucosal abnormalities as identified on screening endoscopy
+10 more criteria

Locations (1)

University of California, San Francisco

San Francisco, California, United States

Key Dates

Start Date

April 1, 2012

Primary Completion Date

December 1, 2014

Completion Date

December 1, 2014

Last Updated

October 8, 2020

Enrollment

ACTUAL participants

Conditions

Type 1 Diabetes

Interventions

Isolated Human Pancreatic Islets

BIOLOGICAL

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 8, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pancreatic Islet Transplantation Into the Gastric Submucosa

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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