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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

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.

Condition or disease Intervention/treatment Phase
Living-relative Kidney Transplantation Procedure: SVF-MSC induction Drug: Basiliximab induction Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cell in Living-Related Kidney Transplants: A Randomized Controlled Trial
Study Start Date : December 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Basiliximab

Arm Intervention/treatment
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
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


Active Comparator: Basiliximab induction
The control group will be inducted with Basiliximab
Drug: Basiliximab induction
The control group will be inducted with Basiliximab before living-relative kidney transplantation and on POD 4




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Incidence of acute rejection [ Time Frame: 1 year ]
    Incidence of acute rejection (biopsy confirmed acute rejection according to Banff creteria)

  3. Incidence of delayed graft function [ Time Frame: 1 month ]
    Incidence of delayed graft function (defined as need for post-transplant dialysis within one week)

  4. Allograft survival [ Time Frame: 1 year ]
    Allograft survival at 1 year post transplant

  5. Infection adverse event [ Time Frame: 1 year ]
    Incidence of death, allograft loss, and hospitalization due to infection at 1 year.

  6. Non-hematologic toxicities [ Time Frame: 1 year ]
    Incidence of grade 3 and above non-hematologic toxicities

  7. Hematologic toxicities [ Time Frame: 1 year ]
    Incidence of grade 4 hematologic toxicities



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02492308


Contacts
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Contact: Tan Jianming, MD, PhD 8613375918000 tanjm156@yahoo.com
Contact: Gao Xia, MD 8659122859175 38704163@qq.com

Locations
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China, Fujian
Xi er huan road No.156 Recruiting
Fuzhou, Fujian, China, 350000
Contact: Tan Jianming, MD, PhD    8613375918000    doctortjm@yahoo.com   
Contact: Gao Xia, MD    8659122859175    38704163@qq.com   
Xi er huan road No.156 Recruiting
Fuzhou, Fujian, China, 350000
Contact: Tan Jianming, MD, PhD    861337598000    doctortjm@yahoo.com   
Contact: Gao Xia, MD    8659122859175    38704163@qq.com   
Sponsors and Collaborators
Fuzhou General Hospital
Investigators
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Study Director: Tan Jianming, MD PhD Fuzhou General Hospital, Xiamen Univ

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Responsible Party: Fuzhou General Hospital
ClinicalTrials.gov Identifier: NCT02492308     History of Changes
Other Study ID Numbers: SVF-LR
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015

Keywords provided by Fuzhou General Hospital:
kidney
transplantation
MSC

Additional relevant MeSH terms:
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Basiliximab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs