Islet Allotransplantation for Type 1 Diabetic Patients

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03259256

Enrollment

Registered

2017-08-23

Start date

2017-04-23

Completion date

2019-06-30

Last updated

2017-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetic

Brief summary

The purpose of this study is to determine if islet cell transplantation , is an effective treatment for type 1 diabetes. Study participants may receive up to three islet transplants and will be followed for five years to monitor blood sugar control, islet transplant function, and changes in quality of life.

Interventions

PROCEDUREAllogeneic transplantation of intrahepatic islet

Allogeneic transplantation of intrahepatic islet is one of the effective methods for diabetic therapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

Clinical diagnosis of type 1 diabetes 18 \<Age \<70 years Evolution of diabetes for more than 5 years Regular patient follow-up (\> or equal to 2 visits per year from the same diabetologist) ABO compatibility with the donor Cross match negative Anti-HLA antibodies (class I and / or class II) detected by lymphocytotoxicity \<20% Accepting patients effective contraception during the study period

Exclusion criteria

Clinical diagnosis of type 2 diabetes BMI \> 28 Need insulin \< 28 U per day Pregnancy, lactation 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 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 \-

Design outcomes

Primary

Measure	Time frame	Description
Obtaining an improvement in glycemic control	nine months after first and last islet transplants	The proportion of subjects with an HbA1c ≤ 6.5% and free of severe hypoglycemic events
normal glycemic control without insulin	3 months after graf	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

Secondary

Measure	Time frame	Description
insulin independence	One year after the last transplant	insulin independence
Hypoglycemic episodes by HYPO score	3 months after transplantation	Hypoglycemic episodes by HYPO score
degenerative complications of diabetes	18 months after transplantation	degenerative complications of diabetes

Countries

China

Contacts

Primary Contactping Xue, PhD

gyeygdwk@163.com0086-020-34153080

Backup Contactxiaofeng Jiang, MD