Interstitial Lung DiseasesPhase 1/2NCT02796781
Autologous Lung Stem Cell Transplantation in Patients With Interstitial Lung Diseases
A Phase 1/2 study testing Lung stem cells in people with Interstitial Lung Diseases, run by Shanghai East Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Interstitial Lung Diseases
- What is being tested?
- Lung stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2016to 31 Aug 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with interstitial lung disease
- Clinically stable
- Written informed consent signed
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Lung stem cells
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung stem cellsBiological
Patients will receive clinical grade lung stem cells (LSCs)injected into lung via fiberoptic bronchoscopy.
| Study group | Role | What they receive |
|---|---|---|
| lung stem cells | Experimental | 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. Receives: Biological: Lung stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of diffusing capacity of the lung for carbon monoxide (DLCO)
Measured: 24 weeks
Secondary outcomes (3)
Increase of total lung capacity (TLC)
Measured: 24 weeks
Increase in 6 minute walk distance (6MWD)
Measured: 24 weeks
Life quality: assessed by St. George respiratory questionnaire (SGRQ)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study start12 Oct 2016
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Regend Therapeutics
- Responsible party
- Principal investigator, Wei Zuo, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796781
- Sponsor's protocol ID
- 201602102
- Status last verified
- Oct 2023
- First submitted
- 7 Jun 2016
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25383540
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Lung Stem Cell Transplantation in Patients With Interstitial Lung Diseases
- ClinicalTrials.gov ID
- NCT02796781
- Acronym / sponsor ID
- 201602102
- Conditions
- Interstitial Lung Diseases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Collaborators
- Regend Therapeutics
- Study start
- 12 Oct 2016 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 13 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lung stem cells | Experimental | Biological: Lung stem cellsPatients 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with interstitial lung disease
- Clinically stable
- Written informed consent signed
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung stem cellsPatients will receive clinical grade lung stem cells (LSCs)injected into lung via fiberoptic bronchoscopy. | Biological | lung stem cells |
Primary outcome
Increase of diffusing capacity of the lung for carbon monoxide (DLCO)
Time frame: 24 weeks
3 secondary outcomes
Increase of total lung capacity (TLC)
Time frame: 24 weeks
Increase in 6 minute walk distance (6MWD)
Time frame: 24 weeks
Life quality: assessed by St. George respiratory questionnaire (SGRQ)
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Background: PubMed 25383540Zuo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lung stem cells in people with Interstitial Lung Diseases, run by Shanghai East Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase of diffusing capacity of the lung for carbon monoxide (DLCO) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02796781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.