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Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Antibody Mediated Kidney Graft Rejection (ABMR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03585855
Recruitment Status : Terminated (Safety reasons)
First Posted : July 13, 2018
Last Update Posted : July 25, 2019
Slovenian Research Agency
Information provided by (Responsible Party):
Veceric-Haler Zeljka, University Medical Centre Ljubljana

Brief Summary:
Transplant rejection is one of the biggest limitations in renal transplant procedures, where the kidney can undergo an acute, late acute, or chronic transplant rejection. With the advancement in transplantation protocols, acute survival of renal transplants has improved, but long-term survival is still unsatisfactory, as most of the renal transplants develop chronic graft rejection. Unfortunately, there is little the investigators know when it comes to improving long-term survival of renal transplants. Mesenchymal stem cells (MSC) have been shown to have immunosuppressive and repairing properties. The purpose of this study is to find out whether MSC in combination with standard therapy of antibody mediated rejection (ABMR) are more effective in preventing organ deterioration and maintaining kidney function.

Condition or disease Intervention/treatment Phase
Interventional Other: MSC transplantation Not Applicable

Detailed Description:
Participants will be assigned to receive the full immunosuppressive therapy indicated to treat chronic ABMR (including plasmapheresis (PF) 7x, intravenous immune globulins 100 mg/kg 7x, corticosteroid) and MSC infusions (2x106cells/kg bw after PF) (Group 1) and be compared to historic controls according to "propensity score matching" (treated with immunosuppressive therapy alone (Group 2)). Patients will undergo MSC infusions at the start of the study after each PF. One year post- infusions, patients will be evaluated and undergo kidney biopsies. Blood collection will occur at regular intervals, serum creatinine and the estimated creatinine clearance will be monthly recorded. The transplanted kidney function and morphology (US Doppler) will be evaluated.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: comparison with historic control
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Antibody Mediated Kidney Graft Rejection (ABMR)
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : July 23, 2019
Actual Study Completion Date : July 23, 2019

Arm Intervention/treatment
No Intervention: Historic control
historic cohort of patients with ABMR treated with standard of care therapy
Experimental: MSC transplantation
patients with ABMR treated with MSC transplantation
Other: MSC transplantation
MSC transplantation: patients with ABMR treated with MSC transplantation

Primary Outcome Measures :
  1. Safety of MSC transplantation as assessed by adverse events according to CTCAE Version 5Estimated glomerular filtration rate (eGFR) [ Time Frame: 12 months ]
    Adverse events according to CTCAE Version 5

Secondary Outcome Measures :
  1. Estimated glomerular filtration rate (eGFR) [ Time Frame: 12 months ]
    eGFR at up to 12 months post MSC transplantation

  2. Graft survival rate [ Time Frame: 12 months ]
    Graft survival rate at 12 months post MSC transplantation

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Recipients of a renal allograft, male and female patients age >18
  • The eGF>20 ml/min/1.73 m2,
  • Renal biopsy Criteria: chronic active ABMR.
  • Written informed consent, compliant with local regulations.

Exclusion Criteria:

  • Recipients of multiple organs.
  • Pregnant women.
  • Malignant disease in last 5 years
  • Active autoimmune disease
  • Active infection including hepatitis B, hepatitis C, HIV, or tuberculosis
  • Evidence of congestive cardiac failure and/or acute coronary syndrome in past 6 months.
  • Evidence of liver disease
  • Inadequate compliance to treatment.

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 identifier (NCT number): NCT03585855

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University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana
Slovenian Research Agency
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Principal Investigator: Željka Večerić-Haler, MDPhDŽeljka Večerić-Haler, MDPhD
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Responsible Party: Veceric-Haler Zeljka, Principal investigator, University Medical Centre Ljubljana Identifier: NCT03585855    
Other Study ID Numbers: P3-0323
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 12 months

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No