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Mesenchymal Stem Cell Transplantation in the Treatment of Chronic ABMR

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ClinicalTrials.gov Identifier: NCT03585855
Recruitment Status : Not yet recruiting
First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Collaborator:
Slovenian Research Agency
Information provided by (Responsible Party):
Veceric-Haler Zeljka, University Medical Centre Ljubljana

Tracking Information
First Submitted Date  ICMJE June 25, 2018
First Posted Date  ICMJE July 13, 2018
Last Update Posted Date July 13, 2018
Estimated Study Start Date  ICMJE September 2018
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2018)
Estimated glomerular filtration rate (eGFR) [ Time Frame: 12 months ]
eGFR at up to 12 months post MSC transplantation
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2018)
  • Graft survival rate [ Time Frame: 12 months ]
    Graft survival rate at 12 months post MSC transplantation
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mesenchymal Stem Cell Transplantation in the Treatment of Chronic ABMR
Official Title  ICMJE Autologous Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Humoral Rejection of Kidney Allograft
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
comparison with historic control
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Interventional
Intervention  ICMJE Other: MSC transplantation
MSC transplantation: patients with ABMR treated with MSC transplantation
Study Arms  ICMJE
  • 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
    Intervention: Other: MSC transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 9, 2018)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2021
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03585855
Other Study ID Numbers  ICMJE P3-0323
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: 12 months
Responsible Party Veceric-Haler Zeljka, University Medical Centre Ljubljana
Study Sponsor  ICMJE University Medical Centre Ljubljana
Collaborators  ICMJE Slovenian Research Agency
Investigators  ICMJE Not Provided
PRS Account University Medical Centre Ljubljana
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP