Autologous Lung Stem Cell Transplantation in Patients With Interstitial Lung Diseases

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02796781

Enrollment

Registered

2016-06-13

Start date

2016-10-12

Completion date

2020-08-31

Last updated

2023-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Lung Diseases

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.

Interventions

BIOLOGICALLung stem cells

Patients will receive clinical grade lung stem cells (LSCs)injected into lung via fiberoptic bronchoscopy.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
Increase of diffusing capacity of the lung for carbon monoxide (DLCO)	24 weeks

Secondary

Measure	Time frame
Increase of total lung capacity (TLC)	24 weeks
Increase in 6 minute walk distance (6MWD)	24 weeks
Life quality: assessed by St. George respiratory questionnaire (SGRQ)	24 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026