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Type 1 DiabetesNCT03162237

Safety and Efficacy Study of Islets Xenotransplantation

A study testing Porcine islets and Autologous Treg in people with Type 1 Diabetes, run by Wei Wang,MD at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Porcine islets and Autologous Treg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
Jul 2013to Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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;
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cell Transplantation and Gene Therapy Institute

    Changsha, Hunan, 410013

Other trials in China

About this study

Official title: Investigation of Safety and Efficacy Study of Islets Xenotransplantation for Patients With Type 1 Diabetes

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.

Conditions
Type 1 Diabetes
Being tested
Porcine islets, Autologous Treg
Keywords
Type1 diabetes, porcine islets, treg cells, immunosuppress, xenotransplantation
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Porcine isletsOther

    Porcine islets: 10000IEQ/Kg;

    Tacrolimus: 0.087mg/kg, Bid;

    mycophemo-latemofetil (MMF): 1g x 2/d;

    NULOJIX(belatacept): Day 1 (prior to transplantation), Day 5, Week 2, Week 4, Week 8, Week 12 10mg/kg

  • Autologous TregOther

    Autologous Treg: 2x10^6/Kg

Study groups in NCT03162237
Study groupRoleWhat they receive
Porcine islets and autologous tregExperimentalPorcine islets:10000 islet equivalent（IEQ）/Kg; Treg:2x10^6/Kg
Receives: Other: Porcine islets; Other: Autologous Treg
AutologousTregActive comparatorAutologous Treg:2x10^6/Kg
Receives: Other: Autologous Treg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood glucose

    Before and after transplantation the patient will be tested the blood glucose. If the blood glucose within 24 hours is stable and no occurrence of diabetic ketoacidosis and hypoglycemia.Thirty percent reduction of exogenous insulin requirement will be considered as effective.

    Measured: 1 year

Secondary outcomes (11)

  1. Porcine C-peptide

    The patient will be detected the porcine C-peptide levels after transplantion every three months.

    Measured: 1 years

  2. Hemoglobin A1c

    After transplantation the patient will be checked hemoglobin A1c every month.The level of HbA1c less than 6.5% was considered as effective.

    Measured: 1 years

  3. AST

    AST will be tested every three months.

    Measured: 1 years

  4. ALT

    ALT will be tested every three months.

    Measured: 1 years

  5. Scr

    Scr will be tested every three months.

    Measured: 1 years

  6. BUN

    BUN will be tested every three months.

    Measured: 1 years

  7. Ultrasonic examination for liver

    Ultrasonic examination will be used for the recipient's liver before transplantation and every three month post transplantation.

    Measured: 1 years

  8. MRI for liver

    MRI will be used for liver before transplantaion and every three month post transplantation.

    Measured: 1 years

  9. Virus detection

    The recipient's serum and peripheral blood monouclear cells (PBMC) will be collected for virus detection every six months.

    Measured: 2 years

  10. Immune cells detection

    The recipient's peripheral blood monouclear cells (PBMC) and the serum will be collected for immune cell's analysis.

    Measured: 1 years

  11. Cytokine detection

    The recipient's peripheral blood monouclear cells (PBMC) and the serum will be collected cytokine beads array (CBA) test.

    Measured: 1 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2017
  2. Study startJul 2013
  3. Primary completionDec 2018
  4. Study completionDec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03162237
Sponsor's protocol ID
CellTransplant&GeneTherapy2013
Status last verified
May 2020
First submitted
29 Jan 2014
Last updated
2 Jun 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Ma X, Mo Z, Chen Y, Zhang S, Liang Q, Zhang J, Dong Q, Yang C, Yang M, Luo MH, Rong P, Cui J, Wang W. Clinical Trial for Safety of Porcine Islet Xenotransplantation From PERV-C Free DPF Donor Piglets in Patients With Type 1 Diabetes. Xenotransplantation. 2026 May-Jun;33(3):e70148. doi: 10.1111/xen.70148.

    PubMed 42305014

Questions about this trial

What is this clinical trial studying?

A study testing Porcine islets and Autologous Treg in people with Type 1 Diabetes, run by Wei Wang,MD at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood glucose (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03162237, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.

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