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Trial record 60 of 498 for:    stem cell kidney

Effect of BM-MSCs on Chronic AMR After Kidney Transplantation

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ClinicalTrials.gov Identifier: NCT02563340
Recruitment Status : Unknown
Verified September 2015 by Changxi Wang, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Not yet recruiting
First Posted : September 30, 2015
Last Update Posted : September 30, 2015
Sponsor:
Collaborator:
Second Affiliated Hospital of Guangzhou Medical University
Information provided by (Responsible Party):
Changxi Wang, First Affiliated Hospital, Sun Yat-Sen University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Other: BM-MSCs Other: Desensitization therapy (PP, IVIG, rituximab or Bortezomib) Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : November 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: 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.
Other Name: allogeneic bone marrow-derived MSCs

Other: 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.

Active Comparator: 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.
Other: 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.




Primary Outcome Measures :
  1. Estimated glomerular filtration rate (eGFR) [ Time Frame: 12 months ]
    eGFR at month 12 after enrollment


Secondary Outcome Measures :
  1. Patient survival rate [ Time Frame: 12 months ]
    patient survival rate at month 12 after enrollment

  2. Graft survival rate [ Time Frame: 12 months ]
    graft survival rate at month 12 after enrollment

  3. Donor specific antibody (DSA) level [ Time Frame: 12 months ]
    Change of DSA level up to 12 months after enrollment

  4. Pathological manifestation [ Time Frame: 12 months ]
    Change of pathological scores according to Banff 2013 criteria

  5. Severe adverse events [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563340


Contacts
Contact: Changxi Wang, M.D., Ph.D 86-20-87333428 wangchx@mail.sysu.edu.cn
Contact: Longshan Liu, M.D., Ph.D 86-20-87306082 liulshan@mail.sysu.edu.cn

Locations
China, Guangdong
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Second Affiliated Hospital of Guangzhou Medical University
Investigators
Study Chair: Changxi Wang, M.D., Ph.D First Affiliated Hospital, Sun Yat-Sen University

Additional Information:
Publications:
Responsible Party: Changxi Wang, Director of Organ Transplant Center, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02563340     History of Changes
Other Study ID Numbers: MSC-KTx-cAMR-150926
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2015

Keywords provided by Changxi Wang, First Affiliated Hospital, Sun Yat-Sen University:
kidney transplantation
antibody-mediated rejection
mesenchymal stem cell therapy
donor specific antibody
acute rejection

Additional relevant MeSH terms:
Antibodies
Immunoglobulins
Rituximab
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Bortezomib
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antirheumatic Agents