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Kidney TransplantationPhase 1/2NCT02563340

Effect of BM-MSCs on Chronic AMR After Kidney Transplantation

A Phase 1/2 study testing BM-MSCs and Desensitization therapy (PP, IVIG, rituximab or Bortezomib) in people with Kidney Transplantation, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study is designed to investigate the efficacy and safety of allogeneic bone marrow-derived mesenchymal stem cells (BM-MSCs) on chronic antibody-mediated rejection (cAMR) after kidney transplantation. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Kidney Transplantation
What is being tested?
BM-MSCs and Desensitization therapy (PP, IVIG, rituximab or Bortezomib)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
Nov 2015to Nov 2017
Phase
Phase 1/2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • kidney transplantation
  • cAMR diagnosis is determined based on renal graft biopsy and DSA examination
  • Patient is willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months

Who cannot join

  • Combined or multi-organ transplantation
  • 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
  • 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
  • Patients with active infection
Show all 14Show fewer
  • 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
  • Patients with severe cardiovascular dysfunction
  • WBC<3*10^9/L or RBC <5g/dL
  • Highly allergic constitution or having severe history of allergies
  • Patients with active peptic ulcer disease, chronic diarrhea, or gastrointestinal problem affect absorption
  • Patients with a history of cancer within the last 5 years
  • Prisoner or patients compulsorily detained (involuntarily incarcerated) for treatment or either a psychiatric or physical (e.g. infectious disease) illness
  • Renal graft function deteriorates due to non-immunological complication, such as surgical issues or drug nephrotoxicity

Trial locations and contacts

1 site in 1 country.

Changxi Wang, M.D., Ph.D contact

86-20-87333428

wangchx@mail.sysu.edu.cn

Longshan Liu, M.D., Ph.D contact

86-20-87306082

liulshan@mail.sysu.edu.cn

China1 site

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510080

Other trials in China

About this study

Official title: Efficacy and Safety of Bone Marrow-derived Mesenchymal Stem Cells (BM-MSCs) on Chronic Antibody-mediated Rejection (cAMR) After Kidney Transplantation: A Multi-center Perspective Study

This study is designed to investigate the efficacy and safety of allogeneic bone marrow-derived mesenchymal stem cells (BM-MSCs) on chronic antibody-mediated rejection (cAMR) after kidney transplantation. Chronic AMR is diagnosed according to Banff criteria 2013 based on renal graft biopsy and donor specific antibodies (DSA) examination. cAMR patients are assigned to MSCs group or control group. Patients in control group are prescribed to current desensitization therapy including at least one of the following treatments: plasmapheresis (PP), intravenous immunoglobulin (IVIG), rituximab or Bortezomib, depending on individual pathological and immunological features (eg. DSA type and titer) of each study subjects. Patients in MSCs group receive additional BM-MSCs therapy besides desensitization treatments as in control group. Allogeneic BM-MSCs (1*10^6/kg) are intravenously administered every two weeks for four consecutive doses. All cAMR patients are followed up for one year. Renal function, DSA level, pathological features, patient/graft survival, and severe adverse events are monitored during the follow-up period. Immunological features of patients in both groups are consecutively examined.

Being tested
BM-MSCs, Desensitization therapy (PP, IVIG, rituximab or Bortezomib)
Keywords
kidney transplantation, antibody-mediated rejection, mesenchymal stem cell therapy, donor specific antibody, acute rejection

What participants receive

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

  • BM-MSCsOther

    Also called allogeneic bone marrow-derived MSCs

    BM-MSCs are from third-party healthy donors, and have no HLA alleles similar to renal allograft donors or reacting to positive anti-HLA antibodies in recipients.

  • Desensitization therapy (PP, IVIG, rituximab or Bortezomib)Other

    At least one drug or treatment is applied as desensitization therapy to decrease DSA, reduce B cells or inhibit plasma cells, depending on individual condition.

Study groups in NCT02563340
Study groupRoleWhat they receive
MSCs groupExperimentalcAMR patients in this group receive additional intravenous allogeneic BM-MSCs (1*10^6/kg) every two weeks for four consecutive doses, besides current desensitization therapy including at least one of the following treatments: plasmapheresis (PP), intravenous immunoglobulin (IVIG), rituximab or Bortezomib.
Receives: Other: BM-MSCs; Other: Desensitization therapy (PP, IVIG, rituximab or Bortezomib)
Control groupActive comparatorcAMR patients in this group receive current desensitization therapy including at least one of the following treatments: plasmapheresis (PP), intravenous immunoglobulin (IVIG), rituximab or Bortezomib.
Receives: Other: Desensitization therapy (PP, IVIG, rituximab or Bortezomib)

What is being measured

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

  1. Estimated glomerular filtration rate (eGFR)

    eGFR at month 12 after enrollment

    Measured: 12 months

Secondary outcomes (5)

  1. Patient survival rate

    patient survival rate at month 12 after enrollment

    Measured: 12 months

  2. Graft survival rate

    graft survival rate at month 12 after enrollment

    Measured: 12 months

  3. Donor specific antibody (DSA) level

    Change of DSA level up to 12 months after enrollment

    Measured: 12 months

  4. Pathological manifestation

    Change of pathological scores according to Banff 2013 criteria

    Measured: 12 months

  5. Severe adverse events

    Measured: 12 months

Timeline

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

  1. First posted30 Sep 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionOct 2017 (estimated)
  4. Study completionNov 2017 (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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02563340
Sponsor's protocol ID
MSC-KTx-cAMR-150926
Status last verified
Sep 2015
First submitted
26 Sep 2015
Last updated
30 Sep 2015
Results posted
No

Publications

  • Peng Y, Ke M, Xu L, Liu L, Chen X, Xia W, Li X, Chen Z, Ma J, Liao D, Li G, Fang J, Pan G, Xiang AP. Donor-derived mesenchymal stem cells combined with low-dose tacrolimus prevent acute rejection after renal transplantation: a clinical pilot study. Transplantation. 2013 Jan 15;95(1):161-8. doi: 10.1097/TP.0b013e3182754c53.

    PubMed 23263506

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BM-MSCs and Desensitization therapy (PP, IVIG, rituximab or Bortezomib) in people with Kidney Transplantation, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

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 3 inclusion and 14 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 30 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Changxi Wang, M.D., Ph.D (86-20-87333428, wangchx@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimated glomerular filtration rate (eGFR) (time frame: 12 months). 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 NCT02563340, which also lists 1 linked publication.

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 30 Sep 2015.

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