A Study of Autologous Induced Islet Body With Type 1 Diabetes

NCT03728296 | Unknown Early Phase 1

• 1 other identifier: islet body-01
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

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

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

  1 year

Study Arms (1)

islet body treatment group

EXPERIMENTAL

Biological: islet body

Interventions

islet body BIOLOGICAL

Transplanting islet bodies under the diaphragm

islet body treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 、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.

You may not qualify if:

• 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
• Incomplete data, affecting effectiveness and safety judges
• Researchers believe that the need for termination of the trial is needed.

Sponsors & Collaborators

• Allife Medical Science and Technology Co., Ltd.: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 2, 2018
• Study Start: January 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2021
• Last Updated: November 2, 2018

Record last verified: 2018-10