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

University Medical Centre Ljubljana

Status: Terminated

Conditions: Interventional

Treatments: Other: MSC transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03585855

P3-0323

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Historic control

No Intervention group

Description:

historic cohort of patients with ABMR treated with standard of care therapy

MSC transplantation

Experimental group

Description:

patients with ABMR treated with MSC transplantation

Treatment:

Other: MSC transplantation