Quality Control of Pancreatic Islet Intended to Islet Graft Cells Intended to Stabilot Islet Graft Protocol

NCT ID: NCT03067324

Last Updated: 2020-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-11

Study Completion Date

2021-07-01

Brief Summary

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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.

Detailed Description

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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.

The project aims to :

* develop the bio-sensor necessary to measure islet membrane electric potential
* develop interface between bio-sensor and user
* correlate analysis data collected by bio-sensor with metabolic results of islet graft

Conditions

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Pancreatic Islet Quality Control

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandrine LABLANCHE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Bogdan CATARGI, MD, PhD

Role: STUDY_DIRECTOR

University Hospital, Bordeaux

Locations

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Besançon University Hospital

Besançon, , France

Site Status RECRUITING

Clermont Ferrand University hospital

Clermont-Ferrand, , France

Site Status NOT_YET_RECRUITING

Grenoble University Hospital

Grenoble, , France

Site Status RECRUITING

Lyon University Hospital

Lyon, , France

Site Status RECRUITING

Montpellier University Hospital

Montpellier, , France

Site Status RECRUITING

Nancy University hospital

Nancy, , France

Site Status NOT_YET_RECRUITING

University hospital of Strasbourg

Strasbourg, , France

Site Status RECRUITING

Geneva University Hospital

Geneva, , Switzerland

Site Status ACTIVE_NOT_RECRUITING

Countries

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France Switzerland

Central Contacts

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Sandrine LABLANCHE, MD, PhD

Role: CONTACT

+33 4 76 63 54 26

Myriam HADDOUCHE

Role: CONTACT

+33476766983

Facility Contacts

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Sophie BOROT, MD, PhD

Role: primary

+33 3 81 66 82 29

Igor TAUVERON, MD, PhD

Role: primary

+33 4 73 75 15 29

Sandrine LABLANCHE

Role: primary

+33476769349

Myriam HADDOUCHE

Role: backup

+33476766983

Charles THIVOLET, MD, PhD

Role: primary

+33 4 78 86 14 87

Anne WOJTUSCISZYN, MD, PhD

Role: primary

+33 4 67 33 83 86

Sophie GIRERD, MD, PhD

Role: primary

+33 3.83.15.31.69

Laurence KESSLER, MD, PhD

Role: primary

+33 3 88 11 62 67

References

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Kusnik-Joinville O, Weill A, Salanave B, Ricordeau P, Allemand H. Prevalence and treatment of diabetes in France: trends between 2000 and 2005. Diabetes Metab. 2008 Jun;34(3):266-72. doi: 10.1016/j.diabet.2008.01.005. Epub 2008 Jun 3.

Reference Type BACKGROUND
PMID: 18524662 (View on PubMed)

Gruessner RW, Gruessner AC. The current state of pancreas transplantation. Nat Rev Endocrinol. 2013 Sep;9(9):555-62. doi: 10.1038/nrendo.2013.138. Epub 2013 Jul 30.

Reference Type BACKGROUND
PMID: 23897173 (View on PubMed)

Ricordi C, Lacy PE, Finke EH, Olack BJ, Scharp DW. Automated method for isolation of human pancreatic islets. Diabetes. 1988 Apr;37(4):413-20. doi: 10.2337/diab.37.4.413.

Reference Type BACKGROUND
PMID: 3288530 (View on PubMed)

Lablanche S, Borot S, Wojtusciszyn A, Bayle F, Tetaz R, Badet L, Thivolet C, Morelon E, Frimat L, Penfornis A, Kessler L, Brault C, Colin C, Tauveron I, Bosco D, Berney T, Benhamou PY; GRAGIL Network. Five-Year Metabolic, Functional, and Safety Results of Patients With Type 1 Diabetes Transplanted With Allogenic Islets Within the Swiss-French GRAGIL Network. Diabetes Care. 2015 Sep;38(9):1714-22. doi: 10.2337/dc15-0094. Epub 2015 Jun 11.

Reference Type BACKGROUND
PMID: 26068866 (View on PubMed)

Lebreton F, Pirog A, Belouah I, Bosco D, Berney T, Meda P, Bornat Y, Catargi B, Renaud S, Raoux M, Lang J. Slow potentials encode intercellular coupling and insulin demand in pancreatic beta cells. Diabetologia. 2015 Jun;58(6):1291-9. doi: 10.1007/s00125-015-3558-z. Epub 2015 Mar 19.

Reference Type BACKGROUND
PMID: 25788295 (View on PubMed)

Renaud S, Catargi B, Lang J. Biosensors in diabetes : how to get the most out of evolution and transpose it into a signal. IEEE Pulse. 2014 May-Jun;5(3):30-4. doi: 10.1109/MPUL.2014.2309577.

Reference Type BACKGROUND
PMID: 24838208 (View on PubMed)

Other Identifiers

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38RC14.041

Identifier Type: -

Identifier Source: org_study_id