Clinical Study on the Safety and Efficacy of Autologous Induced Islet Body With Type 1 Diabetes

Allife Medical Science and Technology Co., Ltd.0 sites20 target enrollmentJanuary 2019

ConditionsType 1 Diabetes

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: Type 1 Diabetes
Sponsor: Allife Medical Science and Technology Co., Ltd.
Enrollment: 20
Primary Endpoint: Occurrence of treatment related adverse events as assessed by CTCAE v4.0
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This is a single centre、single arm、open-label study，to investigate the safety and efficacy of Autologous induced islet body With Type 1 diabetes

Registry

clinicaltrials.gov

Start Date

January 2019

End Date

January 2021

Last Updated

7 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Allife Medical Science and Technology Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female, 18 to 70 years old (including 18 and 70 years old)
•Diagnosed as type I diabetes, the diagnostic criteria refer to the 1990 WHO diabetes diagnostic criteria:
•（1）Diabetes symptoms (hyperglycemia caused by polydipsia, polyphagia, weight loss, itchy skin, blurred vision and other acute metabolic disorders) + random blood glucose ≥ 11.1nmol / L; （2）Fasting blood glucose ≥7.0mmol/L or 75g glucose meets 2-hour blood glucose ≥11.1mmol/L.
•3、Voluntary informed consent is given, agree to follow the trial treatment and visit plan.
•Note: 2 is the venous plasma glucose level, if there is no diabetes symptoms, it is necessary to repeat the test on the next day.

Exclusion Criteria

•Patients with acute complications of diabetes: including diabetic ketosis, diabetic ketoacidosis, diabetes, hyperglycemia, hypertonic state, etc.
•Patients with Severe bacterial and viral infections
•patients are participating in other clinical trials and treating with other immune cellular products (DC, CIK, T, NK, and Car T products with CD19 or other targets)
•Patients with severe cardiovascular and cerebrovascular disease (NYHA class 3-4) cannot cooperate with the study
•Patients with severe liver dysfunction(liver function AST and ALT exceeded 2.5 times the normal upper limit).
•Patients with kidney disease or moderate to severe renal insufficiency (renal function eGFR \<60 ml/min/1.73 m2)
•Women in pregnancy (urine/blood pregnancy test positive) or lactation; men or women with pregnancy plans in the last year; patients are not guaranteed to take effective contraceptive measures during the trial;
•patients were diagnosed as tumor or tumor chemotherapy, radiotherapy and acute uric acid nephropathy within 5 years.
•Other circumstances that researchers do not consider suitable for research.
•Withdrawal from trial, loss of follow-up or death due to other reasons

Outcomes

Primary Outcomes

Occurrence of treatment related adverse events as assessed by CTCAE v4.0

Time Frame: 1 year

Defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment