Effect of BM-MSCs on Chronic AMR After Kidney Transplantation
NCT ID: NCT02563340
Last Updated: 2015-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2015-11-30
2017-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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MSCs group
cAMR 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.
BM-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)
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.
Control group
cAMR patients in this group receive current desensitization therapy including at least one of the following treatments: plasmapheresis (PP), intravenous immunoglobulin (IVIG), rituximab or Bortezomib.
Desensitization therapy (PP, IVIG, rituximab or Bortezomib)
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.
Interventions
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BM-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)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Second Affiliated Hospital of Guangzhou Medical University
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Changxi Wang
Director of Organ Transplant Center
Principal Investigators
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Changxi Wang, M.D., Ph.D
Role: STUDY_CHAIR
First Affiliated Hospital, Sun Yat-Sen University
Locations
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The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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References
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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.
Related Links
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Previous publication
Other Identifiers
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MSC-KTx-cAMR-150926
Identifier Type: -
Identifier Source: org_study_id