Status:
COMPLETED
Mesenchymal Stem Cells and Subclinical Rejection
Lead Sponsor:
Leiden University Medical Center
Conditions:
Organ Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the study is to test the safety and feasibility of autologous mesenchymal stem cell therapy in HLA-DR mismatched patients with subclinical rejection and or an increase in IF?TA in the r...
Detailed Description
Kidney transplantation has improved survival and quality of life for patients with end-stage organ failure. Despite dramatic improvements in short-term survival, long-term survival of renal allografts...
Eligibility Criteria
Inclusion
- Subject is willing to participate in the study and has signed the informed consent.
- Recipients of a first kidney graft from a living HLA-DR mismatched donor (2 HLA-DR mismatches).
- Subjects included in the study must have kidney biopsy proven SCR 4 weeks after transplantation.
- Patients must be on triple immunosuppressive therapy of prednisone, CsA or tacrolimus and MMF according to current protocol.
- Panel Reactive Antibodies (PRA) ≤ 5%.
- Patients must be able to adhere to the study visit schedule and protocol requirements.
- If female and of child-bearing age, subject must be non-pregnant, non-breastfeeding, and use adequate contraception.
- Patients must be able to give informed consent and the consent must be obtained prior to any study procedure.
Exclusion
- Double organ transplant recipient.
- Acute clinical rejection after transplantation.
- Patients with evidence of active infection or abcesses before MSC infusion.
- Patients suffering from hepatic failure.
- Patients suffering from an active autoimmune disease.
- Patients who have had a previous BM transplant.
- A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study.
- Use of any investigational drug after transplantation.
- Documented HIV infection, active hepatitis B, hepatitis C or TB according to current transplantation inclusion criteria.
- 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.
- 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.
- Known recent substance abuse (drug or alcohol).
- Contraindications to undergo a BM biopsy.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00734396
Start Date
February 1 2009
End Date
December 1 2012
Last Update
January 7 2013
Active Locations (1)
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1
Leiden Universitary Medical Center
Leiden, Netherlands, 2333 ZA