NCT02492490

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 8, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

July 8, 2015

Status Verified

November 1, 2014

Enrollment Period

1.9 years

First QC Date

May 20, 2015

Last Update Submit

July 4, 2015

Conditions

Uremia

Keywords

Kidney transplantationDCDStromal Vascular FractionMSC

Outcome Measures

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.

    1 years

Secondary Outcomes (6)

  • Changes in renal function as determined by eGFR and proteinuria

    1 year

  • Incidence of Acute rejection

    1 year

  • Incidence of delayed graft function (DGF)

    3 months

  • Allograft survival

    1 year

  • SAE (severe adverse effects)

    1 year

  • +1 more secondary outcomes

Study Arms (2)

SVF(Stromal Vascular Fraction) derived MSC transprlantation

EXPERIMENTAL

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

Basiliximab

ACTIVE COMPARATOR

induction with Basiliximab during kidney transplantation from DCD

Drug: Basiliximab

Interventions

SVFderived MSC transplantationsOTHER

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.

SVF(Stromal Vascular Fraction) derived MSC transprlantation
BasiliximabDRUG

induction with Basiliximab before kidney transplantation and on POD 4

Basiliximab

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuzhou General Hospital, Xiamen Univ

Fuzhou, Fujian, 350025, China

RECRUITING

MeSH Terms

Conditions

Uremia

Interventions

Basiliximab

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Tan Jianming, MD, PhD

    Fuzhou General Hospital

    STUDY DIRECTOR

Central Study Contacts

Tan Jianming, MD PhD

CONTACT

8613375918000tanjm156@yahoo.com

Tan Jianming, MD PhD

CONTACT

13375918000tanjm156@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2015

First Posted

July 8, 2015

Study Start

December 1, 2014

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

July 8, 2015

Record last verified: 2014-11

Locations

CN(1)