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

NCT ID: NCT03585855

Last Updated: 2019-07-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2019-07-23

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.

Conditions

Interventional

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Historic control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

MSC transplantation

patients with ABMR treated with MSC transplantation

Group Type: EXPERIMENTAL

MSC transplantation

Intervention Type: OTHER

MSC transplantation: patients with ABMR treated with MSC transplantation

Interventions

MSC transplantation

MSC transplantation: patients with ABMR treated with MSC transplantation

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Slovenian Research Agency

OTHER

Sponsor Role: collaborator

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Veceric-Haler Zeljka

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Željka Večerić-Haler, MDPhD

Role: PRINCIPAL_INVESTIGATOR

assist.prof.Željka Večerić-Haler, MDPhD

Locations

University Medical Centre Ljubljana

Ljubljana, , Slovenia

Countries

Slovenia

Other Identifiers

P3-0323

Identifier Type: -

Identifier Source: org_study_id