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

Sponsor
University Medical Centre Ljubljana (Other)
Overall Status
Terminated
CT.gov ID
NCT03585855
Collaborator
Slovenian Research Agency (Other)
4
Enrollment
1
Location
2
Arms
6.7
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: MSC transplantation
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
comparison with historic controlcomparison 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 :
Jan 1, 2019
Actual Primary Completion Date :
Jul 23, 2019
Actual Study Completion Date :
Jul 23, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Safety of MSC transplantation as assessed by adverse events according to CTCAE Version 5Estimated glomerular filtration rate (eGFR) [12 months]

    Adverse events according to CTCAE Version 5

Secondary Outcome Measures

  1. Estimated glomerular filtration rate (eGFR) [12 months]

    eGFR at up to 12 months post MSC transplantation

  2. Graft survival rate [12 months]

    Graft survival rate at 12 months post MSC transplantation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Medical Centre Ljubljana Ljubljana Slovenia 1000

Sponsors and Collaborators

  • University Medical Centre Ljubljana
  • Slovenian Research Agency

Investigators

  • Principal Investigator: Željka Večerić-Haler, MDPhD, assist.prof.Željka Večerić-Haler, MDPhD

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Veceric-Haler Zeljka, Principal investigator, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT03585855
Other Study ID Numbers:
  • P3-0323
First Posted:
Jul 13, 2018
Last Update Posted:
Jul 25, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 25, 2019