Autologous Lung Stem Cell Transplantation in Patients With Interstitial Lung Diseases

Interstitial Lung Diseases Clinical Trial

Official title:

Autologous Lung Stem Cell Transplantation in Patients With Interstitial Lung Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02796781
• Other study ID #: 201602102
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 12, 2016
• Est. completion date: August 31, 2020

Study information

• Verified date: October 2023
• Source: Shanghai East Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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 ?-?)
• Pregnant or lactating women;
• The investigator assessed as inappropriate to participate in this clinical trial.

Related Conditions & MeSH terms

• Interstitial Lung Diseases
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

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

Locations

Country	Name	City	State
China	Shanghai East Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai East Hospital	Regend Therapeutics

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase of diffusing capacity of the lung for carbon monoxide (DLCO)		24 weeks
Secondary	Increase of total lung capacity (TLC)		24 weeks
Secondary	Increase in 6 minute walk distance (6MWD)		24 weeks
Secondary	Life quality: assessed by St. George respiratory questionnaire (SGRQ)		24 weeks