Mesenchymal Stromal Cells in Kidney Transplant Recipients

Kidney Transplant Rejection Clinical Trial

Official title:

Autologous Mesenchymal Stromal Cells to Induce Tolerance in Living-donor Kidney Transplant Recipients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02012153
• Other study ID #: MSC-Tx tolerance
• Secondary ID: 2013-003221-29
• Status: Terminated
• Phase: Phase 1
• Start date: December 4, 2013
• Est. completion date: May 29, 2023

Study information

• Verified date: May 2023
• Source: Mario Negri Institute for Pharmacological Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The general aim of the present study is to test a cell therapy with autologous ex-vivo expanded mesenchymal stromal cells (MSCs) as a strategy to induce tolerance in living-donor kidney transplant recipients. MSCs will be prepared accordingly to established protocols, starting from bone marrow explants of living-donor kidney transplant recipients obtained 3-4 months before kidney transplant. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 29, 2023
• Est. primary completion date: May 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female patients;
• Aged 18 or older;
• Living-donor (related and unrelated, spouse/husband) kidney transplant recipients;
• Non-Human Leukocyte Antigen (HLA) identical with the donor (one or two haplotype mismatches);
• First kidney transplant;
• Capable of understanding the purpose and risk of the study;
• Written informed consent.

Exclusion Criteria:

• MSC donor positive for HIV-1, HIV-2, hepatitis B virus (HBV),hepatitis C virus (HCV), syphilis;
• Specific contraindication to MSC infusion;
• Any clinical relevant condition that might affect study participation and/or study results;
• Pregnant women and nursing mothers;
• Unwillingness or inability to follow study protocol in the investigator's opinion.

Related Conditions & MeSH terms

• Kidney Transplant Rejection

Intervention

Biological:
• Mesenchymal Stromal Cells

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Mario Negri Institute for Pharmacological Research	A.O. Ospedale Papa Giovanni XXIII

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulating naïve and memory T cell count (CD45RA/CD45RO) (flow cytometry analysis).		Changes from baseline at 6 and 12 months after transplant.
Primary	T-cell function by ELISPOT assay in mixed lymphocyte reaction.		Changes from baseline at 6 and 12 months after transplant.
Primary	Number of adverse events.	At each visit the overall clinical condition of the patient will be evaluated and any adverse event will be recorded.	Changes from baseline up to 48 months.
Primary	Circulating regulatory T cell count.		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.