MSC and Kidney Transplant Tolerance (Phase A)

Chronic Renal Failure Clinical Trial

Official title:

Third-party Bone Marrow-derived Mesenchymal Stromal Cells to Induce Tolerance in Recipients of Kidney Transplants From Deceased Donors (Phase A)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02565459
• Other study ID #: Third-party MSC-Tx tolerance A
• Secondary ID: 2015-002186-27
• Status: Recruiting
• Phase: Phase 1
• First received: September 24, 2015
• Last updated: April 5, 2018
• Start date: September 2015
• Est. completion date: December 2021

Study information

• Verified date: April 2018
• Source: A.O. Ospedale Papa Giovanni XXIII
• Contact: Norberto Perico, MD
• Phone: 0039 035 45351
• Email: norberto.perico[@]marionegri.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Biological:
• Mesenchymal Stromal Cells

Locations

Country	Name	City	State
Italy	U.O. Nefrologia e Dialisi	Bergamo

Sponsors (2)

Lead Sponsor	Collaborator
Monia Lorini	Mario Negri Institute for Pharmacological Research

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events	At each visit overall clinical condition of the patient will be evaluated and any adverse event will be recorded.	Changes from baseline through study completion, up to 12 months after transplant.
Primary	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.
Primary	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.
Primary	T-cell function in mixed lymphocyte reaction.	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.	Changes from baseline at 6 and 12 months after transplant.
Primary	Urinary FOXP3 mRNA expression evaluated by real time quantitative PCR		Changes from baseline at 6 and 12 months after transplant.