Autologous Lung Stem Cell Transplantation in Patients With Interstitial Lung Diseases

NCT ID: NCT02796781

Last Updated: 2023-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-12
• Study Completion Date: 2020-08-31

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.

Conditions

Interstitial Lung Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lung stem cells

Intervention Type: BIOLOGICAL

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

Interventions

Lung stem cells

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regend Therapeutics

INDUSTRY

Sponsor Role: collaborator

Shanghai East Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wei Zuo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 25383540 (View on PubMed)

Other Identifiers

201602102

Identifier Type: -

Identifier Source: org_study_id