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NCT Number: NCT02796781

Autologous Lung Stem Cell Transplantation in Patients With Interstitial Lung Diseases

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.

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Key information

Conditions

Interstitial Lung Diseases Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200123, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lung stem cells

Biological

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

Primary outcomes

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

    Time frame: 24 weeks

Secondary outcomes

  1. Increase of total lung capacity (TLC)

    Time frame: 24 weeks

  2. Increase in 6 minute walk distance (6MWD)

    Time frame: 24 weeks

  3. Life quality: assessed by St. George respiratory questionnaire (SGRQ)

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Shanghai East Hospital

Other

Collaborators

  • Regend Therapeutics

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 13, 2016
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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