Cell Therapy for Immunomodulation in Kidney Transplantation

Kidney Transplantation Clinical Trial

Official title:

A Prospective Controlled Trial to Evaluate Safety and Efficacy of in Vitro Expanded Recipient Regulatory T Cell Therapy and Tocilizumab Together With Donor Bone Marrow Infusion in HLA-mismatched Living Donor Kidney Transplant Recipients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03867617
• Other study ID #: Trex001
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: August 1, 2019
• Est. completion date: June 2029

Study information

• Verified date: November 2023
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigates treatment with recipient regulatory T cells and donor bone marrow together with tocilizumab for immunomodulation in living donor kidney transplant recipients.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: June 2029
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient has provided written informed consent.

• Patient is 18 years or older.

• Patient is a planned recipient of a living donor kidney transplant.

• Patient is a planned recipient of an ABO blood group-compatible kidney graft.

• Patient is a planned recipient of a kidney graft from a donor that is not HLA (human leukocyte antigen)-identical.

• Patient is negative for DSA (donor-specific antibodies).

• WOCBP (women of child-bearing potential) must have a negative pregnancy test at inclusion.

• WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the study in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria:

• Patient is EBV (epstein barr virus)-negative on serology.

• Patient is HIV-positive or suffering from chronic viral hepatitis.

• Patient is CMV (cytomegalo virus)-negative and receiving a kidney from a CMV-positive donor.

• Positive T-cell lymphocytotoxic cross match.

• Patient with prior kidney transplant or non-renal solid organ transplant.

• Patient has a known contraindication to any of the protocol-specified treatments.

• Patient had been diagnosed with a malignancy within 5 years prior to study entry, excluding non-metastatic basal or squamous cell carcinoma of the skin.

• Female patients who are breast-feeding.

• Female patients with a positive pregnancy test.

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Other:
• Regulatory T cells
Single infusion of expanded regulatory T cells.

Drug:
• Tocilizumab
Treatment during first month post-transplant.

Other:
• Bone marrow
Infusion of donor bone marrow cells.

Procedure:
• Kidney transplant
Living donor kidney transplantation.

Other:
• Immunosuppressive drug therapy
Immunosuppressive drug therapy.

Locations

Country	Name	City	State
Austria	Medical University of Vienna/Vienna General Hospital	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Wekerle	University Hospital Regensburg

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measured as GVHD (graft-versus-host disease), impaired graft function or patient death	Incidence of composite safety endpoint by 12 months post-transplant.	12 months
Primary	Chimerism	Total leukocyte donor chimerism in blood.	1 month