NL-OMON31649
Completed
Not Applicable
Bone marrow derived mesenchymal stem cells for the treatment of allograft rejection after renal transplantation - MSC and allograft rejection
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- aandoeningen na niertransplantatie
- Sponsor
- eids Universitair Medisch Centrum
- Enrollment
- 15
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Female or male, aged between 18 and 65 years.
- •2\. Subject is willing to participate in the study and has signed the informed consent.
- •3\. Recipents of a first kidney graft from a living HLA\-DR mismatched donor (2 HLA\-DR mismatches).
- •4\. Subjects included in the study must have kidney biopsy proven SCR 4 weeks after transplantation.
- •5\. Patients must be on triple immunosuppressive therapy of prednisone, CsA or tacrolimus and MMF according to current protocol.
- •6\. Panel Reactive Antibodies (PRA) \<\= 5%.
- •7\. Patients must be able to adhere to the study visit schedule and protocol requirements.
- •8\. If female and of child\-bearing age, subject must be non\-pregnant, non\-breastfeeding, and use adequate contraception.
- •9\. Patients must be able to give informed consent and the consent must be obtained prior to any study procedure.
Exclusion Criteria
- •1\. Double organ transplant recipient.
- •2\. Acute clinical rejection after transplantation.
- •3\. Patients with evidence of active infection or abcesses 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 truly informed consent for participation in this study.
- •8\. Use of any investigational drug after transplantation.
- •9\. Documented HIV infection, active hepatitis B, hepatitis C or TB according to current transplantation inclusion criteria.
- •10\. Subjects who currently have an active opportunistic infection (e.g., herpes zoster \[shingles], cytomegalovirus (CMV), Pneumocystis carinii (PCP), aspergillosis, histoplasmosis, or mycobacteria other than TB) after transplantation.
Outcomes
Primary Outcomes
Not specified
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