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Pancreatic Islet Transplantation Into the Gastric Submucosa

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01571817
First received: April 3, 2012
Last updated: August 7, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Biological: Isolated Human Pancreatic Islets
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Type I Diabetes by Pancreatic Islet Transplantation Into The Gastric Submucosa

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Estimated Enrollment: 4
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Key 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
  5. 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)
  6. Must be able to give written informed consent

Exclusion Criteria:

Key Exclusion Criteria:

  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. Severe unremitting diarrhea or other GI disorders potentially interfering with the ability to absorb oral medications
  11. Untreated proliferative retinopathy
  12. Pregnancy or breastfeeding
  13. Female subjects not post-menopausal or surgically sterile who are sexually active but not using an acceptable method of contraception
  14. Active infections
  15. Serologic evidence of infection with HIV, or HbsAg or HCV Ab positive
  16. Major ongoing psychiatric illness
  17. Ongoing substance abuse, drug or alcohol; or recent history of noncompliance
  18. Any condition that in the opinion of the Principal Investigator does not allow safe participation in the study

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01571817

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Andrew M Posselt, M.D., Ph.D. University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01571817     History of Changes
Other Study ID Numbers: Islet-Tx-Sub-DERC
Study First Received: April 3, 2012
Last Updated: August 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
Insulin Dependent

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014