Human Umbilical Cord Mesenchymal Stem Cell Injection for the Treatment of Interstitial Lung Disease

Sponsor
Shanghai Life Science & Technology
Study ID
NCT06534528
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Interstitial Lung Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Human umbilical cord mesenchymal stem cell injection — DRUG
    Different doses of human umbilical cord mesenchymal stem cell injection were infused to the focus of patients with idiopathic pulmonary fibrosis through bronchoscope, and the tolerance of subjects to different doses of human umbilical cord mesenchymal stem cell injection was observed, and the curative effect was preliminarily observed.

Study Details

Main objective: To explore the safety and tolerability of human umbilical cord mesenchymal stem cell injection in the treatment of interstitial lung disease (ILD); Secondary objective: To explore the preliminary effectiveness of human umbilical cord mesenchymal stem cell therapy for interstitial lung disease (ILD) and recommend appropriate cell therapy doses for subsequent clinical studies; Exploring the immunogenicity of human umbilical cord mesenchymal stem cell injection in the treatment of interstitial lung disease (ILD).

Key Dates

First listed
Aug 2, 2024
Start date
Oct 1, 2026
Status verified
May 2026
Primary completion
Oct 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation
    Four different doses were set, and three subjects in each dose plan received human umbilical cord mesenchymal stem cell injection successively. Each subject received a single dose of 6.0\*10\^6, 3.0\*10\^7,6.0\*10\^7, and 9.0\*10\^7 cells / person.

Primary Outcome Measure

Maximum tolerated dose per dose (MTD) [ Time Frame: From the first administration to 4 weeks after administration ]

Central Contacts

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