A Study of Autologous Induced Islet Body With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
islet body
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
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
- Incomplete data, affecting effectiveness and safety judges
- Researchers believe that the need for termination of the trial is needed.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
islet body treatment group
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03728296
First Posted
October 31, 2018
Last Updated
October 31, 2018
Sponsor
Allife Medical Science and Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03728296
Brief Title
A Study of Autologous Induced Islet Body With Type 1 Diabetes
Official Title
Clinical Study on the Safety and Efficacy of Autologous Induced Islet Body With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2019 (Anticipated)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allife Medical Science and Technology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
islet body treatment group
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
islet body
Intervention Description
Transplanting islet bodies under the diaphragm
Primary Outcome Measure Information:
Title
Occurrence of treatment related adverse events as assessed by CTCAE v4.0
Description
Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Incomplete data, affecting effectiveness and safety judges
Researchers believe that the need for termination of the trial is needed.
12. IPD Sharing Statement
Learn more about this trial
A Study of Autologous Induced Islet Body With Type 1 Diabetes
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