Allogeneic Islet Transplantation for the Treatment of Type 1 Diabetes

NCT01974674 | Unknown Phase 2 DMC

• 1 other identifier: P030415
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

It is a multicentre, sequential, phase II clinical trial, aiming at evaluating the allogeneic islet transplantation for the treatment of type 1 diabetes. 19 patients with type 1 diabetes will be included and ideally distributed evenly: patients with unstable diabetes without renal insufficiency (AI group for "islet alone" by the international customary determination) and patients with a functioning kidney transplant (IAK group for "islet after kidney"). The main endpoint will be defined by the restoration of normal glycemic control without insulin at 6 months after graft.

Conditions

Patients With Type 1 Diabetes

Keywords

diabetes; transplantation

Outcome Measures

Primary Outcomes (1)

• restoration of normal glycemic control without insulin

  the restoration of normal glycemic control without insulin therapy will be evaluated by measuring \- A fasting glucose (\> 8 hours) less than 1.25 g/L and a 2 hours glucose after oral intake of 75g of glucose, less than 2 g/L in a patient without insulin for at least 15 consecutive days during the the first 6 months from day 0.

  6 months after graft

Secondary Outcomes (12)

• Restoration of normal glycemic control without insulin for a year

  1 year

• Obtaining an improvement in glycemic control

  within 2 years after inclusion

• Obtaining a remission of diabetes

  within 2 years after inclusion

• Improved metabolic profile determined by the OGTT and hyperglycemic clamp

  within 2 years after inclusion

• Decreased glycemic variability

  within 2 years after inclusion

Study Arms (1)

Allogeneic transplantation of intrahepatic islet

EXPERIMENTAL

Allogeneic transplantation of intrahepatic islet number required for insulin independence of obtaining, with a threshold dose of 9,000 IEQ/kg body weight of the recipient and a maximum sequence number of 3 infusions. The patient will receive after transplantation immunosuppressive therapy with Thymoglobulin for induction, Prograf and Cellcept, both of which are given throughout the duration of the study

Procedure: Allogeneic transplantation of intrahepatic islet

Interventions

Allogeneic transplantation of intrahepatic islet PROCEDURE

Allogeneic transplantation of intrahepatic islet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with type 1 diabetes
• \<Age \<55 years
• Plasma C-peptide \<0.2 ng/ml basal and stimulated glucagon
• Evolution of diabetes for more than 5 years
• Regular patient follow-up (\> or equal to 2 visits per year from the same diabetologist)
• Patient who received the information and have given their consent in writing
• Absence of HIV, hepatitis B and hepatitis C, HTLV-1-2
• ABO compatibility with the donor
• Cross match negative
• Anti-HLA antibodies (class I and / or class II) detected by lymphocytotoxicity \<20%
• PCR negative for the BK virus in the blood (so as not to amplify the BK virus replication with the ATG).
• Accepting patients effective contraception during the study period
• For patients in group IA
• Glomerular filtration rate estimated by the MDRD\> 50 ml/min/1.73m2
• No perception of hypoglycaemia (less than 0.54 mg/dl glucose) at least one value documented in the two years preceding and/or

You may not qualify if:

• BMI \> 28
• Need insulin \> 1 U/kg per day
• Pregnancy, lactation
• Intention of childbearing for the two sexes
• Psychiatric Disorders
• Inability to communicate or cooperate with the investigator
• Lack of therapeutic compliance, including HbA1C \> 12%
• Chronic liver disease
• Proliferative retinopathy unstabilized
• History of cancer, whatever the date, except for basal or squamous cell skin cancers over 1 year.
• Systemic infection
• Chronic high risk of requiring corticosteroids
• Need for long-term corticosteroid, outside that specified in renal transplantation, the patients will be weaned before transplantation
• Anticoagulant vitamin K or antiplatelet treatments
• Disorders of hemostasis TP \<60 % TCA \> 1.5 times the control

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Saint Louis hospital

Paris, Île-de-France Region, 75010, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Pierre CATTAN, MD PhD

CONTACT

33 1 42494786; pierre.cattan@sls.aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 1, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2022
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

FR (1)