Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cells (IxCell hUC-MSC-P) in the Treatment… (NCT06823063) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cells (IxCell hUC-MSC-P) in the Treatment of CTD-ILD
China18 participantsStarted 2025-04-01
Plain-language summary
To evaluate the safety and tolerability of IxCell hUC-MSC-P in the treatment of patients with connective tissue disease-related interstitial lung disease.
To evaluate the efficacy, pharmacokinetics and immunogenicity of IxCell hUC-MSC-P in the treatment of connective tissue disease-associated interstitial lung disease (CTD-ILD).
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Both sexes, aged 18-80 years;
✓. SSc diagnosed according to the 2013 American College of Rheumatology and European League Against Rheumatism (ACR/EULA) criteria:
✓. Pulmonary fibrosis ≥10% was confirmed by high-resolution chest computed tomography (HRCT);
✓. The diffusion capacity for carbon monoxide (DLco) was 30%-89% of the expected value, and progression of interstitial lung disease was found. Progression was confirmed if one of the following criteria was met:
✓. A decline of 10% or more in the percentage of predicted forced vital capacity (FVC%p) within 24 months (significant decline in ventilatory function) despite treatment;
✓. A decline of ≥5% in FVC%p + a decline of ≥15% in DLco (a decline in ventilation function + a decline in diffusion capacity) within 24 months despite treatment;
✓. Within 24 months, high resolution CT (HRCT) showed worsening of pulmonary fibrosis + ≥5% decline in FVC%p (deterioration of lung imaging + decline in ventilatory function), despite treatment.
✓. Despite the treatment, 24 months reduced FVC % p + 5% or higher clinical symptoms (reduced ventilation function + symptoms);
Exclusion criteria
✕. The patients were diagnosed with other lung diseases other than SSc-ILD, such as COPD, lung abscess, lung cancer and other types of connective tissue disease-related interstitial lung disease.
✕. Have obvious acute lung infection requiring anti-infection treatment (treatment of 4 weeks prior to the start of the respiratory tract infection and systemic infection);
✕. History of severe pulmonary hypertension, including right heart failure, cardiac intubation, and parenteral administration of prostaglandin analogues;
✕. History of myocardial infarction or angina pectoris within 6 months before enrollment;
✕. Patients with 3 or more fingertip ulcers when signing the informed consent form or unable to accurately observe fingertip ulcers due to other reasons of the hand;
✕. Allergic to any component of the medication;
✕. Life expectancy of less than 1 year due to diseases other than SSc;
✕. Planned surgical procedures during the trial;