A Study of Autologous Induced Islet Body With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03728296
• Other study ID #: islet body-01
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: January 2019
• Est. completion date: January 2021

Study information

• Verified date: October 2018
• Source: Allife Medical Science and Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 2021
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Biological:
• islet body
Transplanting islet bodies under the diaphragm

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allife Medical Science and Technology Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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