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A phase I study assessing the safety and tolerability of allogeneic mesenchymal stem cell infusion in adults with cystic fibrosis. | LitMetric

AI Article Synopsis

  • Mesenchymal stem cells (MSCs) from bone marrow are being explored as a treatment for cystic fibrosis (CF), potentially reducing lung inflammation and improving antibiotic effectiveness.
  • A phase 1 clinical trial enrolled 15 adults with CF to test the safety and tolerability of different doses of intravenous hMSCs, with no serious adverse events reported during the study period.
  • The preliminary results indicate that hMSC infusions were safe and well-tolerated, suggesting they are worth further investigation as a potential therapy for CF lung disease.

Article Abstract

Background: Mesenchymal stem cells are of particular interest in cystic fibrosis (CF) as a potential therapeutic. Data from pre-clinical studies suggest that allogeneic bone marrow-derived human mesenchymal stem cells (hMSCs) may provide a new therapeutic treatment for CF lung disease by attenuating pulmonary inflammation while decreasing bacterial growth and enhancing antibiotic efficacy.

Methods: Fifteen adults with CF were enrolled in a phase 1 dose-escalation trial of a single intravenous infusion of hMSCs derived from bone marrow aspirates obtained from a single pre-clinically validated healthy volunteer donor. The study employed a 3+3 dose escalation design with subjects receiving a single, intravenous dose of either 1×10, 3×10, or 5×10 hMSCs/kg. Subjects were monitored inpatient for 24 hours and by outpatient visits and telephone calls for 12 months after the infusion. Safety and tolerability were evaluated by monitoring symptoms, patient reported outcome questionnaires, adverse events (AEs), physical exam findings, spirometry, and analyses of safety laboratories. Preliminary evidence for potential efficacy using inflammatory markers in the blood and sputum were also evaluated.

Results: No dose-limiting toxicities, deaths or life-threatening adverse events were observed. Most AEs and serious adverse events (SAEs) were consistent with underlying CF. Vital signs, physical exam findings, spirometry and safety laboratory results showed no significant change from baseline. No trends over time were seen in serum or sputum inflammatory markers nor with clinical spirometry.

Conclusion: Allogeneic hMSC intravenous infusions were safe and well-tolerated in this phase 1 study and warrant additional clinical testing as a potential therapeutic for CF lung disease.

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Source
http://dx.doi.org/10.1016/j.jcf.2022.12.001DOI Listing

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