The safety and efficacy of human umbilical cord mesenchymal stem cell for acute respiratory distress syndrome: an open-label and multicenter phase 1 clinical trial - Summary - MDSpire

The safety and efficacy of human umbilical cord mesenchymal stem cell for acute respiratory distress syndrome: an open-label and multicenter phase 1 clinical trial

  • By

  • Qinggang Ge

  • Libo Zheng

  • Man Zhao

  • Chao Li

  • Zhiling Zhao

  • Zongyu Wang

  • Qiang Zhang

  • Mai Shi

  • Yuxuan Li

  • Jianan Zhang

  • Yixian Qiao

  • Senhao Wei

  • Ning Shen

  • Haomiao Long

  • Yongjun Liu

  • Jie Qiao

  • June 10, 2026

  • 0 min

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Objective:

To evaluate the safety, tolerability, and preliminary efficacy of allogeneic human umbilical cord mesenchymal stem cells (hUC-MSCs) in patients with mild-to-moderate Acute Respiratory Distress Syndrome (ARDS).

Key Findings:
  • No dose-limiting toxicity or treatment-related severe adverse events were observed.
  • The overall 28-day all-cause mortality rate was 8.3%, with 0% mortality among COVID-19-related ARDS patients.
  • Significant improvements in the middle dose group included an increase in PaO2/FiO2 (+100.07 mmHg, P < 0.001) and PaO2 (+21.88 mmHg, P = 0.002).
  • Significant reductions in Lung Injury Score, Sequential Organ Failure Assessment, and Acute Physiology and Chronic Health Evaluation II scores were noted.
Interpretation:

Limitations:
  • Small sample size of 12 patients limits generalizability.
  • Short follow-up period of 28 days may not capture long-term effects.
Conclusion:

Original Source(s)

The safety and efficacy of human umbilical cord mesenchymal stem cell for acute respiratory distress syndrome: an open-label and multicenter phase 1 clinical trial

  • by Qinggang Ge, Libo Zheng, Man Zhao, Chao Li, Zhiling Zhao, Zongyu Wang, Qiang Zhang, Mai Shi, Yuxuan Li, Jianan Zhang, Yixian Qiao, Senhao Wei, Ning Shen, Haomiao Long, Yongjun Liu, Jie Qiao

  • June 10, 2026

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