Pancreatic Islet Quality Control Clinical Trial
— ISLET CHIPOfficial title:
Quality Control of Pancreatic Islet Intended to Islet Graft
| NCT number | NCT03067324 |
| Other study ID # | 38RC14.041 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 11, 2017 |
| Est. completion date | July 1, 2021 |
Islet quality control after pancreatic islets isolation process is insufficient. The Islet Chip study proposes to develop a bio-sensor that will allow a multi-parametric analysis of islet graft based on measurement of islet membrane electric potential.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | July 1, 2021 |
| Est. primary completion date | December 31, 2020 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: - Patients enrolled in STABILOT Pancreatic Islet cell graft protocol and willing to participate to ISLET CHIP Exclusion Criteria: - Patients not enrolled in STABILOT Pancreatic Islet cell graft or patients that signed the form expressing their refuse to participate to ISLET CHIP. |
| Country | Name | City | State |
|---|---|---|---|
| France | Besançon University Hospital | Besancon | |
| France | Clermont Ferrand University hospital | Clermont-Ferrand | |
| France | Grenoble University Hospital | Grenoble | |
| France | Lyon University Hospital | Lyon | |
| France | Montpellier University Hospital | Montpellier | |
| France | Nancy University hospital | Nancy | |
| France | University hospital of Strasbourg | Strasbourg | |
| Switzerland | Geneva University Hospital | Geneva |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Grenoble | University Hospital, Bordeaux |
France, Switzerland,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Beta-score | Beta-score in continuous variable, using the last Beta-score known before the second islet graft. Beta-score is a composite score that reflects pancreatic islet graft function after transplantation and measured from the following criteria: severe hypoglycemia, HbA1c, stimulated C-peptide, fasting glucose, insulin dose or oral diabetes, glycemic variability. | 6 months in average before second islet graft |