Phase 2 Study of Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation With Steroid Free Immunosuppression
Sponsor study identifier
Secondary identifiers
OTHER · Sponsor
OTHER · AFSSAPS
interventional
14
1 country
1
Study Start
March 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2014
Actual (reported)Study Completion
April 2016
Actual (reported)This single center phase 2 clinical trial, is designed for confirming the efficacy and safety of sequential islet allotransplantation with steroid free immunosuppression in patients with previous kidney transplantation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2003
Date type not reportedThis date has not been verified as actual or estimated.
May 11, 2010
Actual (reported)May 14, 2010
Actual (reported)March 2014
Actual (reported)April 2016
Actual (reported)Composite criteria: insulin independence and Glycosylated Hemoglobin (HbA1c) under 8% at one year after the transplantation
Percent of insulin-independent patients with a Glycosylated Hemoglobin (HbA1c) under 8% at one year after injection of approximately 10,000 islets equivalents / kg (IE/kg).
One year
The number of adverse events
1 year
Number of severe episodes of hypoglycemia
1 year
Evaluation of Diabetes complications
1 year
Lipid metabolism
1 year
Evaluation of kidney function
1 year
Islet transplantation
Islet transplantation consisted of up to three sequential fresh islet infusions within three months. Access to the portal vein was gained under general anesthesia by percutaneous catheterisation of a peripheral portal branch under ultrasound guidance or by surgical catheterisation of a small mesenteric vein.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University Hospital of Lille
Lille, Nord, 59000, France
Vantyghem MC, Kerr-Conte J, Arnalsteen L, Sergent G, Defrance F, Gmyr V, Declerck N, Raverdy V, Vandewalle B, Pigny P, Noel C, Pattou F. Primary graft function, metabolic control, and graft survival after islet transplantation. Diabetes Care. 2009 Aug;32(8):1473-8. doi: 10.2337/dc08-1685.
Vantyghem MC, Chetboun M, Gmyr V, Jannin A, Espiard S, Le Mapihan K, Raverdy V, Delalleau N, Machuron F, Hubert T, Frimat M, Van Belle E, Hazzan M, Pigny P, Noel C, Caiazzo R, Kerr-Conte J, Pattou F; Members of the Spanish Back Pain Research Network Task Force for the Improvement of Inter-Disciplinary Management of Spinal Metastasis. Ten-Year Outcome of Islet Alone or Islet After Kidney Transplantation in Type 1 Diabetes: A Prospective Parallel-Arm Cohort Study. Diabetes Care. 2019 Nov;42(11):2042-2049. doi: 10.2337/dc19-0401.
François PATTOU, MD, PhD
University Hospital, Lille
Marie-Christine VANTYGHEM, MD
University Hospital, Lille
Christian NOEL, MD
University Hospital, Lille
Julie KERR-CONTE, MD
Université de Lille 2
14 participants (actual enrollment reported by the registry).
First Submitted
May 11, 2010
First Posted
May 14, 2010
Study Start
March 2003
Date type not reportedThis date has not been verified as actual or estimated.
Islet Allotransplantation With Steroid Free Immunosuppression
Contact the study team to confirm eligibility.
Benomar K, Chetboun M, Espiard S, Jannin A, Le Mapihan K, Gmyr V, Caiazzo R, Torres F, Raverdy V, Bonner C, D'Herbomez M, Pigny P, Noel C, Kerr-Conte J, Pattou F, Vantyghem MC. Purity of islet preparations and 5-year metabolic outcome of allogenic islet transplantation. Am J Transplant. 2018 Apr;18(4):945-951. doi: 10.1111/ajt.14514. Epub 2017 Nov 11.
Caiazzo R, Vantyghem MC, Raverdi V, Bonner C, Gmyr V, Defrance F, Leroy C, Sergent G, Hubert T, Ernst O, Noel C, Kerr-Conte J, Pattou F. Impact of Procedure-Related Complications on Long-term Islet Transplantation Outcome. Transplantation. 2015 May;99(5):979-84. doi: 10.1097/TP.0000000000000458.
Vantyghem MC, Raverdy V, Balavoine AS, Defrance F, Caiazzo R, Arnalsteen L, Gmyr V, Hazzan M, Noel C, Kerr-Conte J, Pattou F. Continuous glucose monitoring after islet transplantation in type 1 diabetes: an excellent graft function (beta-score greater than 7) Is required to abrogate hyperglycemia, whereas a minimal function is necessary to suppress severe hypoglycemia (beta-score greater than 3). J Clin Endocrinol Metab. 2012 Nov;97(11):E2078-83. doi: 10.1210/jc.2012-2115. Epub 2012 Sep 20.
Primary Completion
March 2014
Actual (reported)Study Completion
April 2016
Actual (reported)Last Updated
November 28, 2025
Record last verified: 2025-11
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Source: ClinicalTrials.gov.
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