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Induction With SVF Derived MSC in Living-related Kidney Transplantation

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ClinicalTrials.gov Identifier: NCT02492308
Recruitment Status : Unknown
Verified July 2015 by Fuzhou General Hospital.
Recruitment status was:  Recruiting
First Posted : July 8, 2015
Last Update Posted : July 8, 2015
Sponsor:
Information provided by (Responsible Party):
Fuzhou General Hospital

Tracking Information
First Submitted Date  ICMJE July 4, 2015
First Posted Date  ICMJE July 8, 2015
Last Update Posted Date July 8, 2015
Study Start Date  ICMJE December 2014
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2015)
Effects of autologous SVF derived MSC transplantation on reducing the dosage of immunosuppressant in living-related kidney transplant recipients. [ Time Frame: 1 year ]
Reducing the dosage of immunosuppressant by 30% of CNI in living-related kidney transplant recipients.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2015)
  • Changes in renal function [ Time Frame: 1 year ]
    • Changes in renal function as determined by estimated glomerular filtration rate (eGFR) and proteinuria (>1g) at 1 year post transplant
  • Incidence of acute rejection [ Time Frame: 1 year ]
    Incidence of acute rejection (biopsy confirmed acute rejection according to Banff creteria)
  • Incidence of delayed graft function [ Time Frame: 1 month ]
    Incidence of delayed graft function (defined as need for post-transplant dialysis within one week)
  • Allograft survival [ Time Frame: 1 year ]
    Allograft survival at 1 year post transplant
  • Infection adverse event [ Time Frame: 1 year ]
    Incidence of death, allograft loss, and hospitalization due to infection at 1 year.
  • Non-hematologic toxicities [ Time Frame: 1 year ]
    Incidence of grade 3 and above non-hematologic toxicities
  • Hematologic toxicities [ Time Frame: 1 year ]
    Incidence of grade 4 hematologic toxicities
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Induction With SVF Derived MSC in Living-related Kidney Transplantation
Official Title  ICMJE Effect of Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cell in Living-Related Kidney Transplants: A Randomized Controlled Trial
Brief Summary The objective of this trial is to determine if autologous SVF derived MSC can effectively reduce the need for post transplant immunosuppressant in living-relative kidney transplantation. 120 patients eligible for the study as described below will be enrolled, with 60 patients in intervention group and 60 in control group.
Detailed Description The objective of this trial is to determine if autologous SVF derived MSC can effectively reduce the need for post transplant immunosuppressant in living-relative kidney transplantation. Emphasis will be placed on the safety of autologous SVF derived MSC infusion, dosage of immunosuppressant, GFR, percentage of acute rejection. 120 patients eligible for the study as described below will be enrolled, with 60 patients in intervention group and 60 in control group. In interventional group we will collect SVF from recipients with special instruments before transplantation, and culture SVF to abstain MSC. The abstained MSC will be infused to the recipients of living-relative kidney transplantation during operation and on 7, 14, 21 POD. We will assess whether induction therapy with autologous SVF derived MSC is feasible in living-relative donor kidney transplantation. The effectiveness of autologous SVF derived MSC induction therapy on reducing of immunosuppressant, reducing the rate of rejection, elevating patient and allograft survival, improving allograft function from day 0 to 12 months after transplantation. Additionally, we will assess the percentage of acute rejection or antibody mediated rejection by Banff criteria, the incidence of delayed graft function (defined as the need for post-transplant dialysis within one week), and the incidence of adverse events including infection, grade 3 and above non-hematologic toxicities, and grade 4 hematologic toxicities.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Living-relative Kidney Transplantation
Intervention  ICMJE
  • Procedure: SVF-MSC induction

    Procedure: infusion of autologous SVF derived MSC to the recipients of living-relative kidney transplant.

    Subjects with uremia in the intervention group will undergo puncture to collect SVF, then SVF will be cultured to abstain MSC, and the abstained MSC will be infused to the recipients during kidney transplant operation and on 7, 14, and 21 POD

  • Drug: Basiliximab induction
    The control group will be inducted with Basiliximab before living-relative kidney transplantation and on POD 4
Study Arms  ICMJE
  • Experimental: SVF-MSC induction
    1. collection of autologous SVF
    2. culture of SVF to abstain MSC
    3. infusion of MSC during and after living-relative kidney transplantation
    Intervention: Procedure: SVF-MSC induction
  • Active Comparator: Basiliximab induction
    The control group will be inducted with Basiliximab
    Intervention: Drug: Basiliximab induction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 4, 2015)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1. Uremia patient of any race that is greater than or equal to 18 years of age but less than 60 years old 2. Patient is willing to receive a kidney from a certifiable living-relative donor 18-60 years of age 3. Patient is willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months

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Exclusion Criteria:

  1. 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
  2. Patient with prior solid organ transplant or cell transplant (e.g. bone marrow or islet cell).
  3. 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
  4. Patient receiving a concurrent SOT (heart, liver, pancreas)
  5. ABO incompatible donor recipient pair or CDC crossmatch positive transplant
  6. 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
  7. Donors with cardiac death (non-heart beating donor) 8 Donors or recipients are known hepatitis C antibody-positive or polymerase chain reaction (PCR) positive for hepatitis C

9. Donors or recipients are known hepatitis B surface antigen-positive or PCR positive for hepatitis B 10. Donors or recipients are known human immunodeficiency virus (HIV) infection 11. Recipients at risk for tuberculosis (TB)

  1. Current clinical, radiographic or laboratory evidence of active or latent TB as determined by local standard of care
  2. 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) 12. Recipients with any significant infection or other contraindication that would preclude transplant 13. Recipients with a history of hypercoagulabale state 14. 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.

15. Recipients with active peptic ulcer disease (PUD), chronic diarrhea, or gastrointestinal problem affect absorption 16. Recipients with a history of cancer within the last 5 years (exception: non-melanoma skin cell cancers cured by local resection are permitted) 17. Recipients with a chest radiograph (no more than 2 months prior to randomization) consistent with an acute lung parenchymal process and malignancy 18. Recipients with a hypersensitivity to any study drugs 19. Recipients who have used any investigational drug within 30 days prior to the Day 1 visit 20. Prisoner or patients compulsorily detained (involuntarily incarcerated) for treatment or either a psychiatric or physical (e.g. infectious disease) illness

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Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02492308
Other Study ID Numbers  ICMJE SVF-LR
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fuzhou General Hospital
Study Sponsor  ICMJE Fuzhou General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Tan Jianming, MD PhD Fuzhou General Hospital, Xiamen Univ
PRS Account Fuzhou General Hospital
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP