Status:
COMPLETED
Induction Therapy With Autologous Mesenchymal Stem Cells for Kidney Allografts
Lead Sponsor:
Fuzhou General Hospital
Conditions:
Renal Transplant Rejection
Eligibility:
All Genders
18-60 years
Phase:
NA
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 surviva...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00658073
Start Date
March 1 2008
End Date
October 1 2010
Last Update
March 8 2011
Active Locations (1)
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1
Stem cell therapy center,Fuzhou General Hospital
Fuzhou, Fujian, China, 350025