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Disorder Related to Renal TransplantationPhase 1NCT02490020

A Perspective Multicenter Controlled Study On Application Of Mesenchymal Stem Cell(MSC) To Prevent Rejection After Renal Transplantation By Donation After Cardiac Death

A Phase 1 study testing mesenchymal stem cell in people with Disorder Related to Renal Transplantation and Renal Transplant Rejection, run by Qipeng Sun.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Although donation after cardiac death(DCD) is the major source of renal transplantation in China, high incidence rate of rejection and delayed graft function(DGF) is existing due to the prolonged ischemia time. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
mesenchymal stem cell
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
No sites listed yet
Study dates
Jan 2016to Dec 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Study on prevention of MSC to rejection after transplantation
  • Age between 18-60 years
  • having the indication of renal transplantation
  • having no absolute contraindication
  • renal transplantation by donation after citizen death
  • the first time to receive renal transplantation
Show all 12Show fewer
  • signed informed consent
  • Study on treatment of MSC to rejection after transplantation
  • renal transplantation by donation after citizen death
  • BPAR
  • having no contraindication of renal biopsy
  • signed informed consent

Who cannot join

  • loss to follow-up
  • serious adverse events

About this study

Although donation after cardiac death(DCD) is the major source of renal transplantation in China, high incidence rate of rejection and delayed graft function(DGF) is existing due to the prolonged ischemia time. According to the previous single center study, mesenchymal stem cell (MSC) had an effect to prevent rejection and DGF after renal transplantation, but there was no perspective multicenter controlled study to confirm it. This perspective multicenter controlled study will focus on clarifying the key role of MSC applied via renal arterial or peripheral vein injection, to reduce the rejection and DGF after renal transplantation. The investigators have established GMP workshop and solid research foundation of transplant rejection. This study will provide a new reasonable way for immune induction of renal transplantation by DCD.

Being tested
mesenchymal stem cell
Keywords
Renal transplantation, mesenchymal stem cell, Transplantation Rejection, donation after cardiac death

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mesenchymal stem cellBiological

Study groups in NCT02490020
Study groupRoleWhat they receive
iv of BMSC to prevent rejectionExperimentalRoutine treatment protocol(ATG 50mg*3;MP 2.0g to Pred 30mg,then maintaining 5mg qd;MMF 1.0 bid from the first day after op,then maintaining 1-1.5g/d;Plus CNI from the third day after op)+BMSC iv(2*10^6cell/kg, 48h before op)
Receives: Biological: mesenchymal stem cell
routine treatment protocol to prevent rejectionNo interventionRoutine treatment protocol(ATG 50mg*3;MP 2.0g to Pred 30mg,then maintaining 5mg qd;MMF 1.0 bid from the first day after op,then maintaining 1-1.5g/d;Plus CNI from the third day after op)
ia and iv of MSC to prevent rejectionExperimentalRoutine treatment protocol(ATG 50mg*3;MP 2.0g to Pred 30mg,then maintaining 5mg qd;MMF 1.0 bid from the first day after op,then maintaining 1-1.5g/d;Plus CNI from the third day after op)+BMSC (iv 2*10^6cell/kg + ia 5*10^6cell, 48h before op)
Receives: Biological: mesenchymal stem cell
routine treatment to prevent rejectionNo interventionRoutine treatment protocol(ATG 50mg*3;MP 2.0g to Pred 30mg,then maintaining 5mg qd;MMF 1.0 bid from the first day after op,then maintaining 1-1.5g/d;Plus CNI from the third day after op)
Routine CMR treatment plus MSC to prevent CMRExperimentalRoutine CMR treatment protocol(MP as first line approach, ATG as second line approach,ATG be used to treat BPAR in 1 week after op)+MSC( iv 2*10^6cell/kg at d1,d7)
Receives: Biological: mesenchymal stem cell
Routine CMR treatment to prevent CMRNo interventionRoutine CMR treatment protocol(MP as first line approach, ATG as second line approach,ATG be used to treat BPAR in 1 week after op)
Routine AMR treatment plus MSC to prevent AMRExperimentalRoutine AMR treatment protocol(plasma exchange and IVIG as first line approach, anti-CD20 monoclonal antibody as second line approach)+MSC( iv 2*10^6cell/kg at d1,d7)
Receives: Biological: mesenchymal stem cell
Routine AMR treatment to prevent AMRNo interventionRoutine AMR treatment protocol(plasma exchange and IVIG as first line approach, anti-CD20 monoclonal antibody as second line approach)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numbers of participants enrolled into the MSC group and control group

    80-100 cases will be enrolled to the group.

    Measured: up to one year

  2. Incident rates of BPAR and DGF after renal transplantation with MSC prevention before operation

    Cases enrolled into the group will be monitored renal function,renal biopsy and other opportunistic infection.The incident rates of DGF and BPAR will be calculated and compare with the control group.

    Measured: up to one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionDec 2016 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02490020
Sponsor's protocol ID
zssy20150624
Status last verified
Jul 2015
First submitted
29 Jun 2015
Last updated
3 Jul 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Sun Q, Huang Z, Han F, Zhao M, Cao R, Zhao D, Hong L, Na N, Li H, Miao B, Hu J, Meng F, Peng Y, Sun Q. Allogeneic mesenchymal stem cells as induction therapy are safe and feasible in renal allografts: pilot results of a multicenter randomized controlled trial. J Transl Med. 2018 Mar 7;16(1):52. doi: 10.1186/s12967-018-1422-x.

    PubMed 29514693

  • Sun Q, Hong L, Huang Z, Na N, Hua X, Peng Y, Zhao M, Cao R, Sun Q. Allogeneic mesenchymal stem cell as induction therapy to prevent both delayed graft function and acute rejection in deceased donor renal transplantation: study protocol for a randomized controlled trial. Trials. 2017 Nov 16;18(1):545. doi: 10.1186/s13063-017-2291-y.

    PubMed 29145879

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing mesenchymal stem cell in people with Disorder Related to Renal Transplantation and Renal Transplant Rejection, run by Qipeng Sun.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numbers of participants enrolled into the MSC group and control group (time frame: up to one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02490020, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2015.

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