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Bone marrow–mesenchymal stromal cell infusion in patients with chronic kidney disease: A safety study with 18 months of follow-up

  • Author Footnotes
    * These authors contributed equally to this work.
    Atieh Makhlough
    Footnotes
    * These authors contributed equally to this work.
    Affiliations
    Department of Nephrology, Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran
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  • Author Footnotes
    * These authors contributed equally to this work.
    Soroosh Shekarchian
    Footnotes
    * These authors contributed equally to this work.
    Affiliations
    Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, The Academic Center for Education, Culture and Research (ACECR), Tehran, Iran
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  • Reza Moghadasali
    Affiliations
    Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, The Academic Center for Education, Culture and Research (ACECR), Tehran, Iran

    Department of Stem Cells and Developmental Biology, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, The Academic Center for Education, Culture and Research (ACECR), Tehran, Iran
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  • Behzad Einollahi
    Affiliations
    Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences, Baqiyatallah Hospital, Tehran, Iran
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  • Mona Dastgheib
    Affiliations
    Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, The Academic Center for Education, Culture and Research (ACECR), Tehran, Iran
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  • Ghasem Janbabaee
    Affiliations
    Gastrointestinal Cancer Research Center, Mazandaran University of Medical Sciences, Sari, Iran
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  • Seyedeh Esmat Hosseini
    Affiliations
    Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, The Academic Center for Education, Culture and Research (ACECR), Tehran, Iran
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  • Nasrin Falah
    Affiliations
    Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, The Academic Center for Education, Culture and Research (ACECR), Tehran, Iran
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  • Fateme Abbasi
    Affiliations
    Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, The Academic Center for Education, Culture and Research (ACECR), Tehran, Iran
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  • Hossein Baharvand
    Affiliations
    Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, The Academic Center for Education, Culture and Research (ACECR), Tehran, Iran

    Department of Stem Cells and Developmental Biology, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, The Academic Center for Education, Culture and Research (ACECR), Tehran, Iran
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  • Nasser Aghdami
    Correspondence
    Correspondence: Nasser Aghdami, MD, PhD, No 9, Shaghayegh Alley, Banihashem Sq., Banihashem St., Ressalat highway, Tehran, Iran.
    Affiliations
    Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, The Academic Center for Education, Culture and Research (ACECR), Tehran, Iran
    Search for articles by this author
  • Author Footnotes
    * These authors contributed equally to this work.
Published:March 24, 2018DOI:https://doi.org/10.1016/j.jcyt.2018.02.368

      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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