end-stage renal disease renal disease
Conditions
Interventions
We will include sixteen subjects. Twelve subjects will receive a single
intravenous infusion of ASC. Doses of ASC will escalate from 0.33x106, 1x106 to
3x106 ASC/kg body weight. Four subjects will r
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameters are safety and feasibility. 1 Safety: the number of adverse reactions after ASC infusion 2 Feasibility: generation of sufficient numbers of ASC of ESRD patients with the required characteristics and infusion of the cells within the set timeframe | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary parameters of this study are kidney function and the immunological and regenerative effects of ASC therapy in end-stage renal disease patients. 1 Kidney function: creatinine levels and detection of proteinuria 2 Immunological and regenerative response: serum levels of pro-inflammatory and anti-inflammatory cytokines and growth factors, functionality of peripheral blood mononuclear cells 3 Time frame of effect: timepoint on which maximum levels of immunosuppressive and regenerative markers are measured | — |
Countries
Netherlands
Outcome results
None listed