NL-OMON53310
Not yet recruiting
Not Applicable
Safety and Efficacy of MCA-derived Mesenchymal Stromal Cell Therapy in Renal Transplant Recipients: The Nereid Study* - MCA-derived MSC therapy in renal transplant recipients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- BPAR
- Sponsor
- eids Universitair Medisch Centrum
- Enrollment
- 16
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Female or male, aged between 18 and 75 years.
- •2\. Subject is willing to participate in the study, must be able to give
- •informed consent
- •and the consent must be obtained prior to any study procedure.
- •3\. Recipients of a first kidney graft from a living\-unrelated or non\-HLA
- •identical living related donor.
- •If a donor is \> 50 years of age, recipient must be \>25 years of age.
- •4\. Panel Reactive Antibodies (PRA) \<\= 10%.
- •5\. No HLA repeated mismatch between MCA\-derived MSC and the HLA mismatch
- •between kidney graft and recipient.
Exclusion Criteria
- •1\. Double organ transplant recipient.
- •2\. Biopsy proven acute rejection (according to the Banff criteria) in the first
- •6 weeks after
- •transplantation.
- •3\. Patients with evidence of active infection or abscesses (with the exception
- •uncomplicated urinary tract infection) before MSC infusion.
- •4\. Patients suffering from hepatic failure.
- •5\. Patients suffering from an active autoimmune disease.
- •6\. Patients who have had a previous BM transplant.
- •7\. A psychiatric, addictive or any disorder that compromises ability to give
Outcomes
Primary Outcomes
Not specified
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