Clinical trial NCT00658073: Induction Therapy With Autologous Mesenchymal Stem Cells for Kidney Allografts
Official title: Autologous Bone Marrow Mesenchymal Stem Cell Transplantation in Recipients of Living Kidney Allografts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Transplant Rejection
Keywords: Kidney transplant
Mesenchymal stem cell (MSC)
Lead sponsor: Fuzhou General Hospital
Sponsor class: OTHER
First posted: 2008-04-14
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate autologous MSCs as an alternative for antibody induction therapy in renal transplantation.

Detailed description: Renal transplantation is the most common and successful type of organ transplantation. Induction therapy with antibody plus the maintenance immunosuppressive agents have greatly improved graft survival in renal transplantation. Since mesenchymal stem cells(MSCs)have been used successfully to treat graft versus host disease and show immune modulation function both in vitro and in vivo and may help in repairing damaged tissue(s), we evaluate autologous MSCs as an alternative for antibody induction therapy. Moreover, we examine if MSCs could improve the recovery of early function in transplanted kidney.

Eligibility criteria: Inclusion Criteria:

* Patients must be between the ages of 18 and 60 years and meet the institution's criteria for renal transplantation for end-stage renal failure
* Patient is receiving the first renal transplant
* Patient is receiving a renal transplant only
* Women who are of child bearing potential must have a negative pregnancy test (urine test is acceptable) and agree to use reliable contraception for 1 year following transplant
* Willing to comply with the study visits
* Be able to sign informed consent document.

Note: The subjects do not need to be local residents in order to be eligible for this trial, but must be willing to reside in the area, or within a four hour drive, for the first three months of the protocol so that we can monitor them closely in the early post transplant period.

Exclusion Criteria:

* Previously received or is receiving an organ transplant other than a kidney
* Significant liver disease, defined as having continuously elevated AST (SGOT) or ALT (SGPT) levels greater than 3 times the upper value of the normal range within 28 days prior to study entry
* HIV infection.
* Surface antigen positive for HBV.
* Antibody positive for hepatitis C virus
* Recipient or donor is positive for tuberculosis (TB), under treatment for suspected TB, or previously exposed to TB
* Currently receiving an investigational drug or received an investigational drug within 30 days prior to transplant.
* Currently receiving any immunosuppressive agent.
* Clinically active bacterial, fungal, viral or parasitic infection
* Evidence for immunologic memory against donor.
* Recipients need antibody induction treatment before the operation.
* Current cancer or a history of cancer within the 5 years prior to study entry.
* Serious heart and lung diseases.
* Patients who's RPR is positive
* Pregnancy or breastfeeding.
* Have no ability to communicate.
* Any form of substance abuse, psychiatric disorder, or other condition that, in opinion of the investigator, may interfere with the study

Primary outcomes:
measure: Incidence rate of biopsy-proven acute rejection and early renal function recovery
timeFrame: At 1 year post-transplant
Secondary outcomes:
measure: Patient and graft survival and prevalence of adverse events
timeFrame: At 1 year post-transplant
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Stem cell therapy center,Fuzhou General Hospital
state: Fujian
Study officials:
affiliation: Fuzhou General Hospital
name: Jianming Tan, M.D and Ph.D
role: STUDY_DIRECTOR
References:
citation: Tan J, Wu W, Xu X, Liao L, Zheng F, Messinger S, Sun X, Chen J, Yang S, Cai J, Gao X, Pileggi A, Ricordi C. Induction therapy with autologous mesenchymal stem cells in living-related kidney transplants: a randomized controlled trial. JAMA. 2012 Mar 21;307(11):1169-77. doi: 10.1001/jama.2012.316.