Autologous Lung Stem Cell Transplantation in Patients With Interstitial Lung Diseases
Phase 1
Completed
- Conditions
- Interstitial Lung Diseases
- Registration Number
- NCT02796781
- Lead Sponsor
- Shanghai East Hospital
- Brief Summary
Interstitial lung diseases (ILD) are a group of diseases affecting the lung interstitium. The lung scarring that occurs in ILD is often irreversible with only mitigating therapy available so far. This study intends to carry out an open, single-armed, phase I/II clinical trial to investigate whether lung stem cells can regenerate damaged lung tissue. During the treatment, lung stem cells will be isolated from patients' own bronchi and expanded in vitro. After careful characterization, cultured cells will be injected directly into the lesion by fiberoptic bronchoscopy. The safety and efficacy of the treatment will be monitored by measuring the key clinical indicators.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
- Diagnosed with interstitial lung disease
- Clinically stable
- Written informed consent signed
Exclusion Criteria
- Allergic to cell therapy;
- Patients with serious significant pulmonary infection need anti-infection treatment;
- Patients who has taken amiodarone which may cause pulmonary fibrosis in the past 3 months;
- Patients with malignant tumor in the past 5 years;
- Participated in other clinical trials in the past 3 months;
- Patients with serious heart disease(NYHA class Ⅲ-Ⅳ)
- Pregnant or lactating women;
- The investigator assessed as inappropriate to participate in this clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Increase of diffusing capacity of the lung for carbon monoxide (DLCO) 24 weeks
- Secondary Outcome Measures
Name Time Method Increase in 6 minute walk distance (6MWD) 24 weeks Life quality: assessed by St. George respiratory questionnaire (SGRQ) 24 weeks Increase of total lung capacity (TLC) 24 weeks
Trial Locations
- Locations (1)
Shanghai East Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai East Hospital🇨🇳Shanghai, Shanghai, China