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

Not Applicable

Terminated

• Conditions: Interventional
• Interventions: Other: MSC transplantation

• Registration Number: NCT03585855
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-06-25
• Study First Submitted QC: 2018-07-09
• Study First Posted: 2018-07-13
• Study Start: 2019-01-01
• Status Verified: 2019-07
• Primary Completion: 2019-07-23
• Study Completion: 2019-07-23
• Last Update Submitted: 2019-07-24
• Last Update Posted: 2019-07-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
MSC transplantation	MSC transplantation	patients with ABMR treated with MSC transplantation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Estimated glomerular filtration rate (eGFR)	12 months	eGFR at up to 12 months post MSC transplantation
Graft survival rate	12 months	Graft survival rate at 12 months post MSC transplantation

Trial Locations

Locations (1)

University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia