Effect of SVF Derived MSC in DCD Renal Transplantation
Uremia
About this trial
This is an interventional treatment trial for Uremia focused on measuring Kidney transplantation, DCD, Stromal Vascular Fraction, MSC
Eligibility Criteria
Inclusion Criteria:
- Uremia patient of any race that is greater than or equal to 18 years of age but less than 60 years old
- Patient is willing to receive a kidney from DCD
- Patient is willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months
Exclusion Criteria:
- Women who are pregnant, intend to become pregnant in the next 1 years, breastfeeding, or have a positive pregnancy test on enrollment or prior to study medication administration
- Patient with prior solid organ transplant or cell transplant (e.g. bone marrow or islet cell).
- Patient is deemed likely to have a second solid organ transplant or cell transplant (e.g. bone marrow or islet cell) in next 3 years
- Patient receiving a concurrent SOT (heart, liver, pancreas)
- ABO incompatible donor recipient pair or CDC crossmatch positive transplant
- Sensitized patients (most recent anti-HLA Class I or II Panel Reactive Antibodies (PRA)>10% by a CDC-assay) or patients identified a high immunological risk by the transplant physician
- Donors or recipients are known hepatitis C antibody-positive or polymerase chain reaction (PCR) positive for hepatitis C
- Donors or recipients are known hepatitis B surface antigen-positive or PCR positive for hepatitis B
- Donors or recipients are known human immunodeficiency virus (HIV) infection
Recipients at risk for tuberculosis (TB)
- Current clinical, radiographic or laboratory evidence of active or latent TB as determined by local standard of care
- History of active TB:
(I). Within the last 2 years, even if treated (II) Greater than 2 years ago, unless there is documentation of adequate treatment according to locally accepted clinical practice c. Recipients at risk of reactivation of TB precludes administration of conventional immunosuppressant (as determined by investigator and based upon appropriate evaluation)
- Recipients with any significant infection or other contraindication that would preclude transplant
- Recipients with a history of hypercoagulable state
- Recipients with a history of substance abuse (drugs or alcohol) within the past 6 months, or psychotic disorders that are not capable with adequate study follow-up.
- Recipients with active peptic ulcer disease (PUD), chronic diarrhea, or gastrointestinal problem affect absorption
- Recipients with a history of cancer within the last 5 years (exception: non-melanoma skin cell cancers cured by local resection are permitted)
- Recipients with a chest radiograph (no more than 2 months prior to randomization) consistent with an acute lung parenchymal process and malignancy
- Recipients with a hypersensitivity to any study drugs
- Recipients who have used any investigational drug within 30 days prior to the Day 1 visit
- Prisoner or patients compulsorily detained (involuntarily incarcerated) for treatment or either a psychiatric or physical (e.g. infectious disease) illness -
Sites / Locations
- Fuzhou General Hospital, Xiamen UnivRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
SVF(Stromal Vascular Fraction) derived MSC transprlantation
Basiliximab
transplantation of autologous SVF derived MSC to the recipients of DCD kidney transplant. Subjects with uremia in the intervention group will undergo puncture to collect SVF SVF will be cultured to abstain MSC The abstained MSC will be infused to the recipients during kidney transplant operation and on 7, 14, and 21 POD.
induction with Basiliximab during kidney transplantation from DCD