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Effect of SVF Derived MSC in DCD Renal Transplantation

Primary Purpose

Uremia

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SVFderived MSC transplantations
Basiliximab
Sponsored by
Fuzhou General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uremia focused on measuring Kidney transplantation, DCD, Stromal Vascular Fraction, MSC

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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 DCD
  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 or recipients are known hepatitis C antibody-positive or polymerase chain reaction (PCR) positive for hepatitis C
  8. Donors or recipients are known hepatitis B surface antigen-positive or PCR positive for hepatitis B
  9. Donors or recipients are known human immunodeficiency virus (HIV) infection
  10. 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)

  11. Recipients with any significant infection or other contraindication that would preclude transplant
  12. Recipients with a history of hypercoagulable state
  13. 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.
  14. Recipients with active peptic ulcer disease (PUD), chronic diarrhea, or gastrointestinal problem affect absorption
  15. Recipients with a history of cancer within the last 5 years (exception: non-melanoma skin cell cancers cured by local resection are permitted)
  16. Recipients with a chest radiograph (no more than 2 months prior to randomization) consistent with an acute lung parenchymal process and malignancy
  17. Recipients with a hypersensitivity to any study drugs
  18. Recipients who have used any investigational drug within 30 days prior to the Day 1 visit
  19. 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

Arm Type

Experimental

Active Comparator

Arm Label

SVF(Stromal Vascular Fraction) derived MSC transprlantation

Basiliximab

Arm Description

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

Outcomes

Primary Outcome Measures

Effects of autologous SVF derived MSC transplantation on reducing the dosage of CNI by 30% in Kidney Transplantation from Chinese Donation after Citizen Death
Changes of the immunosuppressant by reducing 30% of CNI dosage.

Secondary Outcome Measures

Changes in renal function as determined by eGFR and proteinuria
Changes in renal function as determined by estimated glomerular filtration rate (eGFR) and proteinuria (>1g)
Incidence of Acute rejection
Incidence of acute rejection (biopsy confirmed acute rejection)
Incidence of delayed graft function (DGF)
Incidence of delayed graft function (defined as need for post-transplant dialysis within one week)
Allograft survival
Allograft survival at 1 year post transplant
SAE (severe adverse effects)
Incidence of death, allograft loss, and hospitalization due to infection at 1 year.
non-hematologic toxicities
Incidence of grade 3 and above non-hematologic toxicities

Full Information

First Posted
May 20, 2015
Last Updated
July 4, 2015
Sponsor
Fuzhou General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02492490
Brief Title
Effect of SVF Derived MSC in DCD Renal Transplantation
Official Title
Effect of Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cell in Kidney Transplantation From Chinese Donation After Citizen Death (DCD): A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuzhou General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this trial is to determine if autologous Stromal Vascular Fraction (SVF) derived Mesenchymal Stem Cell (MSC) infusion during and after kidney transplantation from Donation after Citizen Death (DCD) can effectively reduce the need for post transplant immunosuppressant and elevate GFR of allograft. The investigators will infuse autologous SVF derived MSC to the recipients during and after operation to assess the effect of SVF derived MSC and closely monitor renal function, dosage of immunosuppressant, acute rejection, and graft survival. 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 DCD 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. Kidneys from the same donor of DCD will be random allocated to intervention group and control group. In intervention group the investigators 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 DCD kidney transplantation during operation and on 7, 14, 21 POD. The investigators will assess whether induction therapy with autologous SVF derived MSC is feasible in DCD 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, the investigators 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremia
Keywords
Kidney transplantation, DCD, Stromal Vascular Fraction, MSC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SVF(Stromal Vascular Fraction) derived MSC transprlantation
Arm Type
Experimental
Arm Description
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.
Arm Title
Basiliximab
Arm Type
Active Comparator
Arm Description
induction with Basiliximab during kidney transplantation from DCD
Intervention Type
Other
Intervention Name(s)
SVFderived MSC transplantations
Intervention Description
infusion 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, 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. And the induction therapy of control group will be Basiliximab.
Intervention Type
Drug
Intervention Name(s)
Basiliximab
Intervention Description
induction with Basiliximab before kidney transplantation and on POD 4
Primary Outcome Measure Information:
Title
Effects of autologous SVF derived MSC transplantation on reducing the dosage of CNI by 30% in Kidney Transplantation from Chinese Donation after Citizen Death
Description
Changes of the immunosuppressant by reducing 30% of CNI dosage.
Time Frame
1 years
Secondary Outcome Measure Information:
Title
Changes in renal function as determined by eGFR and proteinuria
Description
Changes in renal function as determined by estimated glomerular filtration rate (eGFR) and proteinuria (>1g)
Time Frame
1 year
Title
Incidence of Acute rejection
Description
Incidence of acute rejection (biopsy confirmed acute rejection)
Time Frame
1 year
Title
Incidence of delayed graft function (DGF)
Description
Incidence of delayed graft function (defined as need for post-transplant dialysis within one week)
Time Frame
3 months
Title
Allograft survival
Description
Allograft survival at 1 year post transplant
Time Frame
1 year
Title
SAE (severe adverse effects)
Description
Incidence of death, allograft loss, and hospitalization due to infection at 1 year.
Time Frame
1 year
Title
non-hematologic toxicities
Description
Incidence of grade 3 and above non-hematologic toxicities
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tan Jianming, MD PhD
Phone
8613375918000
Email
tanjm156@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tan Jianming, MD PhD
Phone
13375918000
Email
tanjm156@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tan Jianming, MD, PhD
Organizational Affiliation
Fuzhou General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Fuzhou General Hospital, Xiamen Univ
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianming Tan, professor
Phone
008613375918000
Email
doctortjm@yahoo.com
First Name & Middle Initial & Last Name & Degree
Xia Gao, MD
Phone
8618065102725
Email
38704163@qq.com
First Name & Middle Initial & Last Name & Degree
Jianming Tan, Professor

12. IPD Sharing Statement

Learn more about this trial

Effect of SVF Derived MSC in DCD Renal Transplantation

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