NCT02796781

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2016

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

October 12, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

3.9 years

First QC Date

June 7, 2016

Last Update Submit

October 15, 2023

Conditions

Interstitial Lung Diseases

Outcome Measures

Primary Outcomes (1)

  • Increase of diffusing capacity of the lung for carbon monoxide (DLCO)

    24 weeks

Secondary Outcomes (3)

  • 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

Study Arms (1)

lung stem cells

EXPERIMENTAL

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.

Biological: Lung stem cells

Interventions

Lung stem cellsBIOLOGICAL

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

lung stem cells

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with interstitial lung disease
  • Clinically stable
  • Written informed consent signed

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200123, China

Location

Related Publications (1)

  • Zuo W, Zhang T, Wu DZ, Guan SP, Liew AA, Yamamoto Y, Wang X, Lim SJ, Vincent M, Lessard M, Crum CP, Xian W, McKeon F. p63(+)Krt5(+) distal airway stem cells are essential for lung regeneration. Nature. 2015 Jan 29;517(7536):616-20. doi: 10.1038/nature13903. Epub 2014 Nov 12.

    PMID: 25383540BACKGROUND

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 7, 2016

First Posted

June 13, 2016

Study Start

October 12, 2016

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

October 17, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)