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Status unknownNCT02492490Updated Jul 8, 2015

Effect of SVF Derived MSC in DCD Renal Transplantation

A Phase 1/2 interventional study of SVFderived MSC transplantations and Basiliximab in Uremia, sponsored by Fuzhou General Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-07-08.

Sponsored by Fuzhou General Hospital · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Uremia

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Keywords

  • Kidney transplantation
  • DCD
  • Stromal Vascular Fraction
  • MSC
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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 -
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    SVF(Stromal Vascular Fraction) derived MSC transprlantation

    transplantation of autologous SVF derived MSC to the recipients of DCD kidney transplant. 1. Subjects with uremia in the intervention group will undergo puncture to collect SVF 2. SVF will be cultured to abstain MSC 3. The abstained MSC will be infused to the recipients during kidney transplant operation and on 7, 14, and 21 POD.

    Other: SVFderived MSC transplantations

  • Active comparator
    Basiliximab

    induction with Basiliximab during kidney transplantation from DCD

    Drug: Basiliximab

Interventions

  • OtherSVFderived MSC transplantations

    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.

  • DrugBasiliximab

    induction with Basiliximab before kidney transplantation and on POD 4

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 years

Secondary outcomes

  1. 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)

    Time frame: 1 year

  2. Incidence of Acute rejection

    Incidence of acute rejection (biopsy confirmed acute rejection)

    Time frame: 1 year

  3. Incidence of delayed graft function (DGF)

    Incidence of delayed graft function (defined as need for post-transplant dialysis within one week)

    Time frame: 3 months

  4. Allograft survival

    Allograft survival at 1 year post transplant

    Time frame: 1 year

  5. SAE (severe adverse effects)

    Incidence of death, allograft loss, and hospitalization due to infection at 1 year.

    Time frame: 1 year

  6. non-hematologic toxicities

    Incidence of grade 3 and above non-hematologic toxicities

    Time frame: 1 year

06

Study locations

1 of 1 sites recruiting
  • Fuzhou General Hospital, Xiamen Univ
    Fuzhou, Fujian 350025, China
    • Jianming Tan, professor · Contact · doctortjm@yahoo.com · 008613375918000
    • Xia Gao, MD · Contact · 38704163@qq.com · 8618065102725
    • Jianming Tan, Professor · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT02492490
Lead sponsor
Fuzhou General Hospital
Responsible party
Sponsor
First posted
Jul 8, 2015
Start date
Dec 2014
Primary completion
Nov 2016 (estimated)
Completion
Nov 2016 (estimated)
Last update
Jul 8, 2015

Study contacts

Tan Jianming, MD PhD
Contact
tanjm156@yahoo.com
8613375918000
Tan Jianming, MD PhD
Contact
tanjm156@yahoo.com
13375918000
Tan Jianming, MD, PhD
study director · Fuzhou General Hospital

Oversight

Data monitoring committee
No
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This study is status unknown, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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