Status:
UNKNOWN
Collection of Human Liver Biopsy and Whole Blood Samples From T1DM, TP or PP Patients for Potential Use for Insulin Producing Cells in Future Clinical Studies
Lead Sponsor:
Orgenesis Ltd.
Conditions:
Type 1 Diabetes
Pancreatectomy; Hyperglycemia
Eligibility:
All Genders
18-70 years
Brief Summary
In this study, liver samples will be collected, processed and stored in a specialized, clinical grade, cell bank for potential future clinical use. A set of ex-vivo immunogenicity and transdiffrentiat...
Eligibility Criteria
Inclusion
- patients between the ages of 18 and 70 years old, inclusive.
- For T1DM - Patients with history of established T1DM undergoing an elective abdominal surgery with an easy access to the liver
- Patients undergoing total or partial Pancreatectomy
- Female patients who agree not to breastfeed during the study up to at least seven days after the study is completed.
- For T1DM - Receiving multiple daily insulin injections or insulin pump therapy.
- For T1DM - HbA1c ≤10%.
- Willing to sign the study informed consent document.
- In good general health with no infections, or concomitant medical conditions that would influence the outcome of the trial, at the discretion of the Investigator and the Sponsor.
Exclusion
- Received any investigational product within 30 days of admission into this study or plan to participate in any other clinical study during the conduct of this study.
- Received methotrexate or other rheumatoid disease modifying agents within the last 6 months.
- Administration of a live vaccine 30 days prior to screening.
- No evidence of liver Cirrhosis or Nonalcoholic Steatohepatitis (NASH, grade 3 and above) within the last month.
- Patients diagnosed with liver viral infections such as HBV, HCV, HIV
- Patients diagnosed with CMV (defined by IgM positive).
Key Trial Info
Start Date :
October 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 20 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04038931
Start Date
October 1 2019
End Date
June 20 2020
Last Update
September 24 2019
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