Allogeneic Islet Transplantation for the Treatment of Type 1 Diabetes

Last updated: September 28, 2016
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

2

Condition

Diabetes Prevention

Diabetes And Hypertension

Diabetes Mellitus, Type 1

Treatment

N/A

Clinical Study ID

NCT01974674
P030415
  • Ages 18-55
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 samediabetologist)

  • 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 virusreplication 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 valuedocumented in the two years preceding and/or

  • Occurrence of at least one severe hypoglycemic episode (with a third required) andunexplained in the two years before and/or at least two episodes of ketoacidosis peryear

  • 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

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 cancersover 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 monthsrequired)

  • Active infection by hepatitis B, hepatitis C and HIV, HTLV-1-HTLV2

  • Ascites

Study Design

Total Participants: 19
Study Start date:
July 01, 2013
Estimated Completion Date:
January 31, 2022

Connect with a study center

  • Saint Louis hospital

    Paris, Ile de France 75010
    France

    Active - Recruiting

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