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A Study of Autologous Induced Islet Body With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03728296
Recruitment Status : Unknown
Verified October 2018 by Allife Medical Science and Technology Co., Ltd..
Recruitment status was:  Not yet recruiting
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Allife Medical Science and Technology Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Biological: islet body Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study on the Safety and Efficacy of Autologous Induced Islet Body With Type 1 Diabetes
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: islet body treatment group Biological: islet body
Transplanting islet bodies under the diaphragm




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
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Responsible Party: Allife Medical Science and Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03728296    
Other Study ID Numbers: islet body-01
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases