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

Interventional Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03585855
• Other study ID #: P3-0323
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: July 23, 2019

Study information

• Verified date: July 2019
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 23, 2019
• Est. primary completion date: July 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Interventional

Intervention

Other:
• MSC transplantation
MSC transplantation: patients with ABMR treated with MSC transplantation

Locations

Country	Name	City	State
Slovenia	University Medical Centre Ljubljana	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	Slovenian Research Agency

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of MSC transplantation as assessed by adverse events according to CTCAE Version 5Estimated glomerular filtration rate (eGFR)	Adverse events according to CTCAE Version 5	12 months
Secondary	Estimated glomerular filtration rate (eGFR)	eGFR at up to 12 months post MSC transplantation	12 months
Secondary	Graft survival rate	Graft survival rate at 12 months post MSC transplantation	12 months