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Pancreatic Islet Transplantation Into the Gastric Submucosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01571817
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Andrew Posselt, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE April 3, 2012
First Posted Date  ICMJE April 5, 2012
Last Update Posted Date October 8, 2020
Study Start Date  ICMJE April 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2020)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Six months ]
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
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pancreatic Islet Transplantation Into the Gastric Submucosa
Official Title  ICMJE Treatment of Type I Diabetes by Pancreatic Islet Transplantation Into The Gastric Submucosa
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE Biological: Isolated Human Pancreatic Islets
Study Arms  ICMJE Experimental: Study intervention
endoscopically-guided intestinal submucosal transplantation of Isolated Human Pancreatic Islets in a type 1 diabetic patient
Intervention: Biological: Isolated Human Pancreatic Islets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 2, 2020)
1
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2012)
4
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01571817
Other Study ID Numbers  ICMJE Islet-Tx-Sub-DERC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrew Posselt, University of California, San Francisco
Study Sponsor  ICMJE Andrew Posselt
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew M Posselt, M.D., Ph.D. University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP