Safety and Efficacy Study of Islets Xenotransplantation

Plain-language summary

This study examined the safety and efficacy of a treatment based on transplanting pig-derived islet cells (porcine islets) together with the patient's own regulatory T cells (autologous Treg) in people with type 1 diabetes. It included patients aged 18-40 who had had type 1 diabetes for at least 5 years with poor blood sugar control. It was a non-phase study that has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

Wei Wang,MD

Intervention

Porcine islets, Autologous Treg

Start date

7/1/2013

Estimated completion

12/1/2018

Countries

China

Related genes

Locations

• Changsha, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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