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10.1186/s13287-017-0557-7

http://scihub22266oqcxt.onion/10.1186/s13287-017-0557-7
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suck abstract from ncbi


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pmid28535817      Stem+Cell+Res+Ther 2017 ; 8 (ä): ä
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  • Safety and tolerability of autologous bone marrow mesenchymal stromal cells in ADPKD patients #MMPMID28535817
  • Makhlough A; Shekarchian S; Moghadasali R; Einollahi B; Hosseini SE; Jaroughi N; Bolurieh T; Baharvand H; Aghdami N
  • Stem Cell Res Ther 2017[]; 8 (ä): ä PMID28535817show ga
  • Background: Autosomal dominant polycystic kidney disease (ADPKD) is a genetic ciliopathy disease characterized by progressive formation and enlargement of cysts in multiple organs. The kidneys are particularly affected and patients may eventually develop end-stage renal disease (ESRD). We hypothesize that bone marrow mesenchymal stromal cells (BMMSCs) are renotropic and may improve kidney function via anti-apoptotic, anti-fibrotic, and anti-inflammatory effects. In this study, we aim to assess the safety and tolerability of a BMMSC infusion in ADPKD patients. Methods: We performed a single-arm phase I clinical trial with a 12-month follow-up. This study enrolled six eligible ADPKD patients with an estimated glomerular filtration rate (eGFR) of 25?60 ml/min/1.73 m2. Patients received autologous cultured BMMSCs (2?×?106 cells/kg) through the cubital vein according to our infusion protocol. We investigated safety issues and kidney function during the follow-up visits, and compared the findings to baseline and 1 year prior to the intervention. Results: There were no patients lost to follow-up. We observed no cell-related adverse events (AE) and serious adverse events (SAE) after 12 months of follow-up. The mean eGFR value of 33.8?±?5.3 ml/min/1.73 m2 1 year before cell infusion declined to 26.7?±?3.1 ml/min/1.73 m2 at baseline (P?=?0.03) and 25.8?±?6.2 ml/min/1.73 m2 at the 12-month follow-up visit (P?=?0.62). The mean serum creatinine (SCr) level of 2?±?0.3 mg/dl 1 year before the infusion increased to 2.5?±?0.4 mg/dl at baseline (P?=?0.04) and 2.5?±?0.6 mg/dl at the 12-month follow-up (P?=?0.96). This indicated significant changes between the differences of these two periods (12 months before infusion to baseline, and 12 months after infusion to baseline) in SCr (P?=?0.05), but not eGFR (P?=?0.09). Conclusions: This trial demonstrated the safety and tolerability of an intravenous transplantation of autologous BMMSCs. BMMSC efficacy in ADPKD patients should be investigated in a randomized placebo-controlled trial with a larger population, which we intend to perform. Trial registration: ClinicalTrials.gov, NCT02166489. Registered on June 14, 2014. Electronic supplementary material: The online version of this article (doi:10.1186/s13287-017-0557-7) contains supplementary material, which is available to authorized users.
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