Autologous Lung Stem Cell Transplantation in Patients With Interstitial Lung Diseases

Phase 1

Completed

• Conditions: Interstitial Lung Diseases
• Interventions: Biological: Lung stem cells

• 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

Study Timeline

• Study First Submitted: 2016-06-07
• Study First Submitted QC: 2016-06-07
• Study First Posted: 2016-06-13
• Study Start: 2016-10-12
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-15
• Last Update Posted: 2023-10-17

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

Arm && Interventions

Group	Intervention	Description
lung stem cells	Lung stem cells	Patients will receive 0.5-5x10\^6 (0.5-5 million)/Kg/person cells of clinical grade lung stem cells (LSCs)injected into lung via fiberoptic bronchoscopy.

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