Clinical trial NCT03162237: Safety and Efficacy Study of Islets Xenotransplantation
Official title: Investigation of Safety and Efficacy Study of Islets Xenotransplantation for Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type1 diabetes
porcine islets
treg cells
immunosuppress
xenotransplantation
Lead sponsor: Central South University
Sponsor class: OTHER
Collaborators: name: Hunan Xeno-life Science Ltd
First posted: 2017-05-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The neonatal pig islets will be used as donor culturing with our modified culture medium. At the same time the autologous T regulatory cells will be used to induce specific immune tolerance for porcine islets grafts combined the costimulation of T cell activation channel blockers. The treatment for type 1 diabetes will be evaluated the efficacy and safety.


Eligibility criteria: Inclusion Criteria:

* Male and female patients age 18 to 40 years of age;
* Type 1 diabetes mellitus for at least 5 years;
* Body weight 40 to 60kg;
* Ability to provide written informed consent;
* Manifest signs and symptoms that are severe enough to be incapacitating;
* Patients with poor diabetes control (HbA1c \> 9% );
* Patients have diabetes ketoacidosis or hypoglycemia more than once

Exclusion Criteria:

* Age \< 18 years or \> 60 years;
* Diabetes history \< 5 years;
* Body weight \> 80 kg;
* Exogenous insulin requirement \> 1 unit/kg/day;
* Blood test: hemoglobin male \< 90g/l, female \< 90 g/l) or Wbc \<3×109/L, lymphocyte \<1.5×10\^9/L; or platelet \< 80×10\^9/L; activated- partial-thromboplastin-time （APTT） \> normal value (31-43s)10s;
* Liver dysfunction;
* Kidney dysfunction;
* Cardiopulmonary dysfunction;
* Combined mental illness, cancer, infection, severe trauma, pancreatitis, surgery or other stress situations for patients; gastric ulcer patients, any bleeding disorders, tuberculosis infection and active infection including hepatitis B, hepatitis C, HIV, or John Cunningham virus;
* Serological detection Epstein-Barr virus (EBV) or Cytomegalovirus (CMV)negative;
* Patient have taken immunosuppressant in recent one year With high incidence of malignancy in three generation;
* Women not using effective contraception of childbearing age, or planning pregnancy in nearly two years or being pregnant or lactating;
* Patients can not comply with the research program to complete the diagnosis and treatment;
* Patients not be passed by Ethics committee

Primary outcomes:
measure: Blood glucose
timeFrame: 1 year
Secondary outcomes:
measure: Porcine C-peptide
timeFrame: 1 years
measure: Hemoglobin A1c
timeFrame: 1 years
measure: AST
timeFrame: 1 years
measure: ALT
timeFrame: 1 years
measure: Scr
timeFrame: 1 years
measure: BUN
timeFrame: 1 years
measure: Ultrasonic examination for liver
timeFrame: 1 years
measure: MRI for liver
timeFrame: 1 years
measure: Virus detection
timeFrame: 2 years
measure: Immune cells detection
timeFrame: 1 years
measure: Cytokine detection
timeFrame: 1 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Cell Transplantation and Gene Therapy Institute
state: Hunan
Study officials:
affiliation: Cell transplantation and gene therapy, the 3rd Xiangya hospital of Central South University
name: Wei Wang, PHD,MD
role: STUDY_CHAIR
References: