MSC and Kidney Transplant Tolerance (Phase A)

Phase 1

• Conditions: Chronic Renal Failure
• Interventions: Biological: Mesenchymal Stromal Cells

• Registration Number: NCT02565459
• Lead Sponsor: Monia Lorini

Brief Summary

The general aim of the present study is to test a cell therapy with third-party ex-vivo expanded bone marrow-derived mesenchymal stromal cells (MSCs) as a strategy to induce tolerance in kidney transplant recipients with a deceased donor. MSCs will be prepared accordingly to established protocols, starting from the remnants in the bag and filter at the end of the bone marrow infusions. From these samples, MSCs will be expanded in good manufacturing practice (GMP) approved facilities and used for the present study in patients undergoing kidney transplantation.

The proposed study will be developed in two phases: i) a pilot explorative safety/biologic-mechanistic phase (Phase A), ii) a pilot efficacy phase (Phase B).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-24
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-06
• Primary Completion: 2021-09
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• First single kidney transplant;
• Capable of understanding the purpose and risk of the study;
• Written informed consent.

Exclusion Criteria

• PRA >10%;
• Specific contraindication to MSC infusion;
• Any clinical relevant condition that might affect study participation and/or study results;
• Childbearing potential without effective contraception;
• Pregnant women and nursing mothers;
• Unwillingness or inability to follow study protocol in the investigator's opinion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mesenchymal Stromal Cells (MSC)	Mesenchymal Stromal Cells	A single intravenous infusion (1-2 millions of MSCs per kilogram body weight) of ex-vivo expanded third-party (from healthy donors) MSCs will be performed in patients randomized to the MSC procedure in addition to the kidney transplantation.

Primary Outcome Measures

Name	Time	Method
Number of adverse events	Changes from baseline through study completion, up to 12 months after transplant.	At each visit overall clinical condition of the patient will be evaluated and any adverse event will be recorded.
Circulating naive and memory T cell count (CD45RA/CD45RO) (flow cytometry analysis)	Changes from baseline at 7, 14, 30 days after transplant and then every six months through study completion, up to 12 months after transplant.
Circulating regulatory T cell count.	Changes from baseline at 7, 14, 30 days after transplant and then every six months through study completion, up to 12 months after transplant.
T-cell function in mixed lymphocyte reaction.	Changes from baseline at 6 and 12 months after transplant.	IFNg-producing T cells (spots/300.000 cells) and CD8+ T cell-mediated cytotoxicity (percentage of specific lysis) will be measured in mixed lymphocyte reaction.
Urinary FOXP3 mRNA expression evaluated by real time quantitative PCR	Changes from baseline at 6 and 12 months after transplant.

Trial Locations

Locations (1)

U.O. Nefrologia e Dialisi; 🇮🇹 Bergamo, Italy