Application of mesenchymal stem cells in patients with end-stage renal disease

Withdrawn

Conditions: end-stage renal disease
renal disease
10029149

Registration Number: NL-OMON34665

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 16

Inclusion Criteria

Kidney transplantation candidate with a willing donor
Pre-emptive (not yet on dialysis)
Glomerular filtration rate is between 15 and 25
Female subjects must be non-pregnant and non-breast-feeding

Exclusion Criteria

Subject is HIV1, HIV2, Hepatitis B, Hepatitis C or HTLV positive
Subject has active infection or abscess
Subject has evidence or prior history of active malignancy
Subject previously received an organ transplant
Subject uses immunosuppressive medication

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameters are safety and feasibility.<br /><br><br /><br>1 Safety: the number of adverse reactions after ASC infusion<br /><br>2 Feasibility: generation of sufficient numbers of ASC of ESRD patients with<br /><br>the required characteristics and infusion of the cells within the set timeframe</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary parameters of this study are kidney function and the<br /><br>immunological and regenerative effects of ASC therapy in end-stage renal<br /><br>disease patients.<br /><br><br /><br>1 Kidney function: creatinine levels and detection of proteinuria<br /><br>2 Immunological and regenerative response: serum levels of pro-inflammatory and<br /><br>anti-inflammatory cytokines and growth factors, functionality of peripheral<br /><br>blood mononuclear cells<br /><br>3 Time frame of effect: timepoint on which maximum levels of immunosuppressive<br /><br>and regenerative markers are measured</p><br>