Scholarlink

<p>Autologous CD133+ bone marrow-derived stem cell (BMDSC) therapy has been designated as an Orphan Drug by the EMA and FDA for the treatment of Asherman Syndrome (AS). This phase 1/2, non-randomized, open-label, single-arm trial assessed the safety and efficacy of this novel therapy in 20 infertile women with moderate to severe AS, unresponsive to prior hysteroscopic treatments. Primary endpoints were safety and tolerability over 15 months follow-up, including during pregnancy and after live birth. The therapy was well tolerated with a mean dosage of 125.41 × 10<sup>6</sup> cells, with no treatment-related serious adverse events and only reversible events such as arm pain, headache, and nausea. In pregnant patients, minor obstetric complications were reflux-related cough (<i>n</i> = 1), gestational diabetes (<i>n</i> = 2), cervical shortening requiring pessary placement (<i>n</i> = 2), and postpartum placenta accreta (<i>n</i> = 1). No preterm labor occurred, and all six newborns remained free of significant adverse events. Our findings suggest that autologous CD133 + BMDSC therapy is a safe and effective treatment for AS. Clinical trial registration (Eudra CT): 2016-003975-23</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Autologous cell therapy with CD133+ bone marrow-derived stem cells for Asherman Syndrome: a phase 1/2 trial

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年1月2日

查看全文
  • Xavier Santamaria,
  • María Pardo-Figuerez,
  • Javier González-Fernández,
  • Sergi Querol,
  • Luciano Rodríguez,
  • David Valcárcel,
  • Carla González,
  • Estefanía Fernandez,
  • Diego Amorós,
  • Michael Robles,
  • Sofia Granados-Aparici,
  • Sheila Zuñiga,
  • Francisco Martinez,
  • Diana Valbuena,
  • Carlos Gómez,
  • Julio Herrero,
  • Ramon Aurell,
  • Juan José Torrent,
  • Felipe Vilella,
  • Petr Volkov,
  • Francisco Raga,
  • Rosa Noguera,
  • Hugh S. Taylor,
  • Carlos Simon

摘要

Autologous CD133+ bone marrow-derived stem cell (BMDSC) therapy has been designated as an Orphan Drug by the EMA and FDA for the treatment of Asherman Syndrome (AS). This phase 1/2, non-randomized, open-label, single-arm trial assessed the safety and efficacy of this novel therapy in 20 infertile women with moderate to severe AS, unresponsive to prior hysteroscopic treatments. Primary endpoints were safety and tolerability over 15 months follow-up, including during pregnancy and after live birth. The therapy was well tolerated with a mean dosage of 125.41 × 106 cells, with no treatment-related serious adverse events and only reversible events such as arm pain, headache, and nausea. In pregnant patients, minor obstetric complications were reflux-related cough (n = 1), gestational diabetes (n = 2), cervical shortening requiring pessary placement (n = 2), and postpartum placenta accreta (n = 1). No preterm labor occurred, and all six newborns remained free of significant adverse events. Our findings suggest that autologous CD133 + BMDSC therapy is a safe and effective treatment for AS. Clinical trial registration (Eudra CT): 2016-003975-23