Status:
TERMINATED
Mesenchymal Stem Cells Under Basiliximab/Low Dose RATG to Induce Renal Transplant Tolerance
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Conditions:
Kidney Transplant
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
This a pilot, explorative study to define the safety and biological/mechanistic effect of the systemic intravenous infusion of syngeneic ex-vivo expanded MSCs in living-related kidney transplant recip...
Detailed Description
INTRODUCTION In organ transplantation the immunosuppressive drugs have dramatically improved the life of transplant recipients over the past 30 years, but two notable problems remain:drug-associated t...
Eligibility Criteria
Inclusion
- Male and female patients
- Aged 18 or older
- Non-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
- MSC donor positive for HIV-1, HIV-2, HBV, 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00752479
Start Date
May 1 2008
End Date
December 1 2013
Last Update
December 4 2023
Active Locations (1)
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1
Nephrology Unit
Bergamo, BG, Italy, 24128