NL-OMON40295
Completed
Not Applicable
Safety of allogeneic bone marrow derived mesenchymal stromal cell therapy in renal transplant recipients - MSCs therapy in renal recipients
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 12
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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.
- •4\.Panel Reactive Antibodies (PRA) \<\= 50%.
- •5\.Patients must be able to adhere to the study visit schedule and protocol requirements.
- •6\.If female and of child\-bearing age, subject must be non\-pregnant, non\-breastfeeding, and use adequate contraception.
Exclusion Criteria
- •1\. Double organ transplant recipient.
- •2\. Biopsy proven acute rejection (according to the Banff criteria) in the 4 weeks before MSC infusion.
- •3\. Patients with evidence of active infection or abscesses (with the exception of an uncomplicated urinary tract infection) before MSC infusion.
- •4\. Patients suffering from hepatic failure.
- •5\. Patients suffering from an active autoimmune disease.
- •6\. A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study.
- •7\. Use of any investigational drug after transplantation.
- •8\. Documented HIV infection, active hepatitis B, hepatitis C or TB according to current transplantation inclusion criteria.
- •9\. Subjects who currently an active opportunistic infection at the time of MSC infusion (e.g., herpes zoster \[shingles], cytomegalovirus (CMV), Pneumocystis carinii (PCP), aspergillosis, histoplasmosis, or mycobacteria other than TB, BK) after transplantation.
- •10\. Malignancy (including lymphoproliferative disease) within the past 2\-5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence) according to current transplantation inclusion criteria.
Investigators
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