Autologous Lung Stem Cell Transplantation in Patients With Interstitial Lung Diseases

October 15, 2023 updated by: Wei Zuo, Shanghai East Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200123
        • Shanghai East Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: Lung stem cells
Patients will receive clinical grade lung stem cells (LSCs)injected into lung via fiberoptic bronchoscopy.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai East Hospital

Collaborators

Regend Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2016

Primary Completion (Actual)

August 31, 2020

Study Completion (Actual)

August 31, 2020

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 7, 2016

First Posted (Estimated)

June 13, 2016

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 15, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201602102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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