UC-MSC Injection — Umbilical Cord MSC for Interstitial Lung Disease, Phase 1
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| Trial ID | NCT06534528 ↗ |
|---|---|
| Sponsor | Shanghai Life Science & Technology · China |
| Cell Source | 제대 중간엽줄기세포 (UC-MSC) · allogeneic |
| Indication | interstitial-lung-disease |
| Phase | PHASE 1 |
| Status | NOT-YET-RECRUITING |
| Delivery Route | injection (systemic administration) |
| Enrollment | 24 |
| Publication | — |
Trial Design
This is a Phase 1 clinical trial evaluating the safety and tolerability of human umbilical cord mesenchymal stem cell (UC-MSC) injection in patients with interstitial lung disease. The primary objective is to identify the maximum tolerated dose. Secondary endpoints include forced vital capacity (FVC), diffusing capacity of the lungs for carbon monoxide (DLCO), St. George’s Respiratory Questionnaire (SGRQ), modified Medical Research Council (mMRC) dyspnea score, and cough evaluation.
Clinical Significance
Interstitial lung disease encompasses conditions that can lead to pulmonary fibrosis, dyspnoea, reduced exercise capacity, and a declining quality of life. UC-MSCs have attracted interest in pulmonary regenerative medicine research because of their anti-inflammatory, immunomodulatory, and tissue-repair properties. While this study remains at an early stage, it represents a meaningful exploration of MSC-based therapeutic potential in the pulmonary domain.
Reasons this study is drawing attention:
- MSC-based cell therapy — umbilical cord-derived mesenchymal stem cells
- Pulmonary regenerative medicine — interstitial lung disease as the target indication
- Safety-focused design — primary aim of identifying maximum tolerated dose and dose-limiting toxicities
- Respiratory outcome measures — FVC, DLCO, mMRC, and SGRQ included as secondary endpoints
Limitations and Discussion
As a Phase 1 study, it is premature to make efficacy claims. Interstitial lung disease encompasses a heterogeneous group of conditions, and response may vary depending on participant characteristics. Future studies should incorporate objective assessments of exercise capacity, ambulatory function, and activities of daily living — not only pulmonary function test values.