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Nature

Breakthrough Research in a Top-Tier Journal

Nature

Signal Transduction and Targeted Therapy
Top Nature Journal · IF 39.3
Published 2025

"Randomized, Single-Blind, Placebo-Controlled Clinical Trial of Inhaled hUCMSC-Derived Exosomes for Pulmonary Fibrosis Treatment"

Principal Investigator

Prof. Chang Zhijie

School of Basic Medicine, Tsinghua University

Clinical Registry

ChiCTR2300075466

MR-46-22-004531

Study Design

Randomized · Single-Blind

Placebo-Controlled

Participating Institutions

3 Top Medical Centers

Tsinghua + PLA General + Hainan Affiliated

Clinical Data

Clinically Validated Core Data

Safety Assessment (Perfect Score)

Zero serious adverse events

Normal blood, liver & kidney function

No abnormal IL-6 inflammation markers

Well-tolerated by 79-year-old patient

Efficacy Results

Treatment vs. Control Group Improvement Rate

Treatment Group (≥3 indicators improved) 83.3% (10/12)

Control Group (placebo) 16.7% (2/12)

* Treatment group efficacy rate is 5× that of the control group

+12.5%

FVC Forced Vital Capacity

Average improvement in treatment group (control only +3.2%)

+Significant

MVV Maximal Voluntary Ventilation

Significant improvement in maximal ventilation

Greatly Improved

SGRQ Respiratory Health Score

St. George's Respiratory Questionnaire score greatly improved

2 Reversed

HRCT Imaging Breakthrough

Significant lesion regression in post-inflammatory fibrosis patients

Key Animal Study Results (Bleomycin Pulmonary Fibrosis Model)

20% → 80%

Survival Rate

4× increase

Significantly Restored

Lung Volume

Reduced lung injury

Markedly Improved

Blood Oxygen Saturation

Lung function indicator

Significantly Decreased

Fibrosis Markers

Col1a1 / Fibronectin

Research Team

Research Standing on the Shoulders of Giants

🎓

Prof. Chang Zhijie

Corresponding Author

School of Basic Medicine, Tsinghua University

Authority in precision medicine and stem cell exosomes; research group focuses on cell-free therapy for pulmonary fibrosis.

🏥

PLA General Hospital Team

Clinical Collaborator

Prof. Yan Muyang's Team

China's leading military medical center with extensive respiratory clinical experience, responsible for trial execution and data monitoring.

🏨

Hainan Medical University First Hospital

Clinical Collaborator

Prof. Xu Lu's Team

Joint trial institution providing large-scale patient recruitment and long-term follow-up support.

Scientific Evidence

Breakthrough Research in a Top-Tier Journal

"Randomized, Single-Blind, Placebo-Controlled Clinical Trial of Inhaled hUCMSC-Derived Exosomes for Pulmonary Fibrosis Treatment"

Clinically Validated Core Data

Safety Assessment (Perfect Score)

Efficacy Results

Treatment vs. Control Group Improvement Rate

Key Animal Study Results (Bleomycin Pulmonary Fibrosis Model)

Research Standing on the Shoulders of Giants

Prof. Chang Zhijie

PLA General Hospital Team

Hainan Medical University First Hospital

Nature-Backed Research · Scientific Lung Protection