Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation

NCT01123187 | Completed DMC

• 3 other identifiers: CP 95/12098001DGS 980032
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes; Organ Transplantation; Immunosuppression

Keywords

diabetes type 1; kidney transplantation; islet; hypoglycemia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

Study Arms (1)

islet transplantation

EXPERIMENTAL

Islet transplantation

Procedure: islet transplantation

Interventions

islet transplantation PROCEDURE

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.

Also known as: surgical catheterisation, percutaneous catheterisation

islet transplantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 diabetes mellitus. Documentation of negative basal and stimulated C-peptide and diagnosis of diabetes for at least 5 years.
• Recipient of renal transplant with good function (creatinine clearance \>/=60 ml/min)
• Stable immunosuppression consisting of any combination of sirolimus, tacrolimus for at least 6 months, without major complications
• Ability to give informed consent.
• Age greater than or equal to 18 years or less than or equal to 65 years
• No evidence of liver disease (liver enzymes \< twice the upper limit of normal)

You may not qualify if:

• Age below 18 years and above 65 years
• Significant cardiovascular disease, including non-correctable coronary artery disease and/or recent myocardial infarction(within last 12 months); extensive peripheral vascular disease not correctable by surgery, unstable angina
• Untreated proliferative retinopathy.
• Recent Cerebrovascular accident (within last 12 months)
• Recent unresolved acute infection, or chronic infection, including tuberculosis, HIV, HBV, HCV, CMV or positive skin test for TB
• Any history of malignancy, except squamous or basal skin cancer or in situ cancer of the cervix.
• History of non-compliance, or inability to demonstrate capacity to comply with strict blood glycemic control and insulin pump therapy.
• Psychiatric illness that is untreated, or likely to interfere significantly with transplantation despite treatment.
• Pregnant women, women intending future pregnancy, women of reproductive potential who are unable or unwilling to follow effective contraceptive measures for the duration of immunosuppressive therapy
• Fasting C-peptide \> 0.2 ng/ml
• Creatinine \> 25mg/l
• Alkaline phosphatase, total bilirubin, Alanine Aminotransferase (ALT)or Aspartate Aminotransferase (AST) \> twice the upper limit of normal
• Significant liver disease (elevation of liver enzymes \> twice the upper limit of normal for each of ALT and AST, liver masses including portal vein thrombosis, evidence of portal hypertension, or significant, untreated gallbladder disease (i.e., gallstones).

Sponsors & Collaborators

• University Hospital, Lille: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

University Hospital of Lille

Lille, Nord, 59000, France

Location

Related Publications (5)

• 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.

  PMID: 19638525 RESULT

• 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.

  PMID: 31615852 DERIVED

• 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.

  PMID: 28941330 DERIVED

• 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.

  PMID: 25393157 DERIVED

• 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.

  PMID: 22996144 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Interventions

Islets of Langerhans Transplantation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Endocrine Surgical Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• François PATTOU, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

• Marie-Christine VANTYGHEM, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

• Christian NOEL, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

• Julie KERR-CONTE, MD

  Université de Lille 2

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Islet transplantation

Study Record Dates

• First Submitted: May 11, 2010
• First Posted: May 14, 2010
• Study Start: March 1, 2003
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2016
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)