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Mesenchymal Stem Cell Transplantation in the Treatment of Chronic 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03585855
Recruitment Status : Not yet recruiting
First Posted : July 13, 2018
Last Update Posted : July 13, 2018
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)
Estimated Enrollment : 10 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 Humoral Rejection of Kidney Allograft
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2021

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

Secondary Outcome Measures :
  1. Graft survival rate [ Time Frame: 12 months ]
    Graft survival rate at 12 months post MSC transplantation

  2. Safety of MSC transplantation as assessed by adverse events according to CTCAE Version 5 [ Time Frame: 12 months ]
    Adverse events according to CTCAE Version 5

Information from the National Library of Medicine

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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 ABMR.
  • Written informed consent, compliant with local regulations.

Exclusion Criteria:

  • Recipients of multiple organs.
  • Pregnant women.
  • Previous history of malignancy or malignant haematologic disease
  • 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.

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Responsible Party: Veceric-Haler Zeljka, Principal investigator, University Medical Centre Ljubljana Identifier: NCT03585855     History of Changes
Other Study ID Numbers: P3-0323
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
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