Highlights
- •This is the longest follow-up trial and it showed the safety of autologous BM-MSCs in patients with CKD.
- •This study provides an important foundation for future trials to assess efficacy of autologous BM-MSCs in CKD.
Abstract
Background
Chronic kidney disease (CKD) is a progressive loss of kidney function and structure
that affects approximately 13% of the population worldwide. A recent meta-analysis
revealed that cell-based therapies improve impaired renal function and structure in
preclinical models of CKD. We assessed the safety and tolerability of bone marrow–mesenchymal
stromal cell (MSC) infusion in patients with CKD.
Methods
A single-arm study was carried out at one center with 18-month follow-up in seven
eligible patients with CKD due to different etiologies such as hypertension, nephrotic
syndrome (NS) and unknown etiology. We administered an intravenous infusion (1–2 × 106 cells/kg) of autologous cultured MSCs. The primary endpoint was safety, which was
measured by number and severity of adverse events. The secondary endpoint was decrease
in the rate of decrease in estimated glomerular filtration rate (eGFR). We compared
kidney function during the follow-up visits to baseline and 18 months prior to the
intervention.
Results
Follow-up visits of all seven patients were completed; however, we have not observed
any cell-related adverse events during the trial. Changes in eGFR (P = 0.10) and serum creatinine (P = 0.24) from 18 months before cell infusion to baseline in comparison with baseline
to 18 months were not statistically significant.
Conclusions
We showed safety and tolerability of a single-dose infusion of autologous MSCs in
patients with CKD.
Key Words
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Article info
Publication history
Published online: March 24, 2018
Accepted:
February 11,
2018
Received:
November 26,
2017
Identification
Copyright
© 2018 Published by Elsevier Inc. on behalf of International Society for Cellular Therapy.
