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

NCT03585855 | Terminated

• 1 other identifier: P3-0323
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Interventional

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Estimated glomerular filtration rate (eGFR)

  12 months

• Graft survival rate

  12 months

Study Arms (2)

Historic control

NO INTERVENTION

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

MSC transplantation

EXPERIMENTAL

patients with ABMR treated with MSC transplantation

Other: MSC transplantation

Interventions

MSC transplantation OTHER

MSC transplantation: patients with ABMR treated with MSC transplantation

MSC transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• Slovenian Research Agency: collaborator

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Study Officials

• Željka Večerić-Haler, MDPhD

  assist.prof.Željka Večerić-Haler, MDPhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: comparison with historic control

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 13, 2018
• Study Start: January 1, 2019
• Primary Completion: July 23, 2019
• Study Completion: July 23, 2019
• Last Updated: July 25, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)