ADSCs Therapy in Patients With CTD-ILD

Sponsor
China Medical University Hospital
Study ID
NCT06574581
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Connective Tissue Diseases
  • Interstitial Lung Disease

Eligibility Criteria

Sex
ALL
Age
20 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • ADSC01 — BIOLOGICAL
    The initial 3 subjects will receive low-dose AD-MSC (1x10E6 cells/kg) infusion therapy only once; if no adverse events after 4 weeks, the next 4-7 subjects will receive medium-dose AD-MSC (1x10E6 cells/kg) infusion therapy twice; if no adverse events after 4 weeks of the last infusion, the next 8-10 subjects will receive high-dose AD-MSC (1x10E6 cells/kg) infusion therapy three times.

Study Details

Connective tissue disease (CTD), an autoimmune and inflammatory disease, usually accompanied by lung interstitial/alveolar inflammation and fibrosis (so called interstitial lung disease, ILD). The prevalence and mortality rate of CTD-ILD increase in recent several years. Although the use of corticosteroids and strong immunosuppressants can improve ILD in some patients with CTD, progressive lung fibrosis which needs lung transplantation and results in respiratory failure, even with mortality is observed. Currently, stem cell therapy is a breakthrough in the treatment of CTD-ILD, and the effective therapy with stem cells for patients with ILD have been reported.

Key Dates

First listed
Aug 28, 2024
Start date
Aug 20, 2024
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ADSC01
    1. Low-dose AD-MSC (1x10E6 cells/kg); 2. Medium-dose AD-MSC (2x10E6 cells/kg) 3. High-dose AD-MSC (3x10E6 cells/kg)

Primary Outcome Measure

Safety profile (between the first infusion of AD-MSCs and 48 weeks after the last infusion of AD-MSCs) [ Time Frame: 48 weeks ]

Central Contacts

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