Allogeneic Islet Transplantation for the Treatment of Type 1 Diabetes

NCT ID: NCT01974674

Last Updated: 2016-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2022-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Allogeneic transplantation of intrahepatic islet

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

Group Type: EXPERIMENTAL

Allogeneic transplantation of intrahepatic islet

Intervention Type: PROCEDURE

Interventions

Allogeneic transplantation of intrahepatic islet

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with type 1 diabetes
• 18 <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
• Occurrence of at least one severe hypoglycemic episode (with a third required) and unexplained in the two years before and/or at least two episodes of ketoacidosis per year
• Average HbA1c> 8.5% over two years, despite intensified treatment (basal pattern, bolus)

• For patients in the IAK
• functional renal graft for at least 1 year
• glomerular filtration rate> 50 ml/min/1.73 m2
• proteinuria <0.5 g/day
• Absence of acute rejection in renal previous 6 months

Exclusion Criteria

• 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
• Progressive heart disease myocardial infarction within 6 months prior to inclusion, unbalanced CHD)
• 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
• Anti-HLA antibodies ( class I and/or class II ) detected by lymphocytotoxicity > 20%
• Platelets < 100 giga/L and/or neutrophils <1.5 giga/L
• Chronic intoxication by alcohol, tobacco, or other substance (abstinence > 6 months required)
• Active infection by hepatitis B, hepatitis C and HIV, HTLV-1-HTLV2
• Ascites

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Saint Louis hospital

Paris, Île-de-France Region, France

Site Status: RECRUITING

Countries

France

Central Contacts

Pierre CATTAN, MD PhD

Role: CONTACT

pierre.cattan@sls.aphp.fr

33 1 42494786

Facility Contacts

Pierre CATTAN, MD PhD

Role: primary

pierre.cattan@sls.aphp.fr

33 1 42494786

Other Identifiers

P030415

Identifier Type: -

Identifier Source: org_study_id