Skip to main content

Table 1 Assessment schedule

From: Autologous bone marrow derived mesenchymal stromal cell therapy in combination with everolimus to preserve renal structure and function in renal transplant recipients

Baseline

 

Tx date

Protocol renal biopsy

First MSC infusion

Second MSC infusion

        

Week

 

D0

W4 a 5

W6

W7

W8

W9

W10

W12

W14

W16

W20

W24

BM harvesting

 

X

           

MSC expansion, generating

 

X

           

Informed consent

X

            

Medical history

X

X

X

X

X

X

X

X

X

X

X

X

X

Concomitant medication

X

X

X

X

X

X

X

X

X

X

X

X

X

Transplantation information

X

X

X

X

X

X

X

X

X

X

X

X

X

Physical examination

X

X

X

X

X

X

X

X

X

X

X

X

X

Routine lab

X

X

X

X

X

X

X

X

X

X

X

X

X

Viral load CMV and BK

 

X

X

X

 

X

 

X

 

X

 

X

X

Urinalysis

X

X

X

X

X

X

X

X

X

X

X

X

X

MSC infusion

   

X

X

        

Renal biopsy

 

X

X

         

X

Sera for storage

 

X

X

  

X

  

X

   

X

Iohexol clearance

  

X

         

X

Blood for immune monitoring

 

X

X

X

 

X

  

X

   

X

DSA

 

X

X#

     

X

   

X

Safety assessment

X

X

X

X

X

X

X

X

X

X

X

X

X

Echo cardiography and pulse wave velocity

  

X

         

X

  1. Follow up study visits are planned at baseline, day of transplantation, during the renal biopsy (week 4 a 5), during the first and second MSC infusion at week 6 and 7, week 8, 9, 10, 12, 14, 16, 20, 24 after transplantation.