Back to resultsAutologous Lung Stem Cell Transplantation in Patients With Interstitial Lung Diseases
Primary Purpose
Interstitial Lung Diseases
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Lung stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Lung Diseases
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.
Sites / Locations
- Shanghai East Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
lung stem cells
Arm Description
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.
Outcomes
Primary Outcome Measures
Increase of diffusing capacity of the lung for carbon monoxide (DLCO)
Secondary Outcome Measures
Increase of total lung capacity (TLC)
Increase in 6 minute walk distance (6MWD)
Life quality: assessed by St. George respiratory questionnaire (SGRQ)
Full Information
NCT ID
NCT02796781
First Posted
June 7, 2016
Last Updated
October 15, 2023
Sponsor
Shanghai East Hospital
Collaborators
Regend Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT02796781
Brief Title
Autologous Lung Stem Cell Transplantation in Patients With Interstitial Lung Diseases
Official Title
Autologous Lung Stem Cell Transplantation in Patients With Interstitial Lung Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 12, 2016 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai East Hospital
Collaborators
Regend Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lung stem cells
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Lung stem cells
Intervention Description
Patients will receive clinical grade lung stem cells (LSCs)injected into lung via fiberoptic bronchoscopy.
Primary Outcome Measure Information:
Title
Increase of diffusing capacity of the lung for carbon monoxide (DLCO)
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Increase of total lung capacity (TLC)
Time Frame
24 weeks
Title
Increase in 6 minute walk distance (6MWD)
Time Frame
24 weeks
Title
Life quality: assessed by St. George respiratory questionnaire (SGRQ)
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200123
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25383540
Citation
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.
Results Reference
background
Learn more about this trial
Autologous Lung Stem Cell Transplantation in Patients With Interstitial Lung Diseases
We'll reach out to this number within 24 hrs