Autologous Lung Stem Cell Transplantation in Patients With Interstitial Lung Diseases

Tongji University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Interstitial Lung Diseases

Treatments: Biological: Lung stem cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02796781

201602102

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

lung stem cells

Experimental group

Description:

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.

Treatment:

Biological: Lung stem cells