A Study of Autologous Induced Islet Body With Type 1 Diabetes

October 31, 2018 updated by: Allife Medical Science and Technology Co., Ltd.

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female, 18 to 70 years old (including 18 and 70 years old)
  2. 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:

  1. Patients with acute complications of diabetes: including diabetic ketosis, diabetic ketoacidosis, diabetes, hyperglycemia, hypertonic state, etc.
  2. Patients with Severe bacterial and viral infections
  3. 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)
  4. Patients with severe cardiovascular and cerebrovascular disease (NYHA class 3-4) cannot cooperate with the study
  5. Patients with severe liver dysfunction(liver function AST and ALT exceeded 2.5 times the normal upper limit).
  6. Patients with kidney disease or moderate to severe renal insufficiency (renal function eGFR <60 ml/min/1.73 m2)
  7. 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;
  8. patients were diagnosed as tumor or tumor chemotherapy, radiotherapy and acute uric acid nephropathy within 5 years.
  9. Other circumstances that researchers do not consider suitable for research.
  10. Withdrawal from trial, loss of follow-up or death due to other reasons
  11. Incomplete data, affecting effectiveness and safety judges
  12. Researchers believe that the need for termination of the trial is needed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: islet body treatment group
Biological: islet body
Transplanting islet bodies under the diaphragm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allife Medical Science and Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2019

Primary Completion (ANTICIPATED)

January 1, 2020

Study Completion (ANTICIPATED)

January 1, 2021

Study Registration Dates

First Submitted

October 31, 2018

First Submitted That Met QC Criteria

October 31, 2018

First Posted (ACTUAL)

November 2, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 2, 2018

Last Update Submitted That Met QC Criteria

October 31, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • islet body-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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