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Idiopathic Pulmonary FibrosisPhase 1/2NCT02745184

Clinical Efficacy and Safety of Autologous Lung Stem Cell Transplantation in Patients With Idiopathic Pulmonary Fibrosis

A Phase 1/2 study testing Lung stem cells in people with Idiopathic Pulmonary Fibrosis, run by Shanghai East Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Idiopathic pulmonary fibrosis (IPF) is a chronic and ultimately fatal disease characterized by a progressive damage of lung structure and decline in lung function.This study intends to carry out an open, single-center, non-randomized, self control phase I clinical trial. Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
Lung stem cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
30 Mar 2017to 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 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, aged between 50 to 75;
  • Subjects diagnosed with IPF according to guidelines for the diagnosis of idiopathic pulmonary fibrosis 2018 edition;
  • Subjects with 30%~79% of the predicted value in diffusing capacity for carbon monoxide (DLCO) in pulmonary function tests 3 months before screening;
  • Subjects with typical High-resolution computed tomography (HR-CT) imaging findings of idiopathic pulmonary fibrosis in the past 12 months;
  • Subjects tolerant to bronchofiberscope;
  • Subjects fully informed of the purpose, method and possible discomfort of the trial, agreeing to participate in the test, and voluntarily signing the informed consent;
  • Subjects with good adherence, willingness to take medication and regular follow-up examinations as required by the protocol;
  • Subjects able to understand and cooperate with the completion of pulmonary function tests.

Who cannot join

  • Subjects who cannot tolerate cell therapy;
  • Pregnant or lactating women;
  • Subjects with syphilis or any of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) positive antibody; Of which stable HBV carriers after drug treatment (DNA titer ≤500 IU/mL or copy number <1000 copies/mL) and cured hepatitis C patients (HCV RNA is negative) can be enrolled;
  • Subjects with malignant tumors or a history of malignant tumors;
  • Subjects with serious significant pulmonary infection and needing anti-infection treatment;
  • Subjects with taking drugs which caused lung fibroblast such as amiodarone in a long term before screening;
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  • Subjects with infections in lung or other site, including bacterial and viral infections, requiring intravenous treatment before cell transplantation;
  • Subjects with a history of invasive or noninvasive mechanical ventilation within 4 weeks;
  • Subjects with any of the following lung diseases: asthma, active tuberculosis, pulmonary embolism, pneumothorax, pulmonary hypertension, pneumoconiosis, etc.; lung cancer, bronchiolitis obliterans or other active lung disease; Pneumonia currently or within the last 4 weeks; Pneumonectomy Previously;
  • Subjects needing oxygen therapy currently (oxygen therapy time> 15h/d);
  • Subjects suffering from serious other systemic diseases, such as myocardial infarction, unstable angina, liver cirrhosis, acute glomerulonephritis, connective tissue disease, etc.;
  • Subjects with following results : leukopenia (leukopenia < 4×10^9/L) or agranulocytosis (leukocyte < 1.5×10^9/L or neutrophils < 0.5×10^9/L) of any cause; Blood creatinine > 2.5 times the upper limit of normal; Alanine transaminase (ALT) and Aspartate transaminase (AST) > 2.5 times the upper limit of normal values in the laboratory tests;
  • Subjects with a history of mental illness or suicide risk, epilepsy or other central nervous system disorders;
  • Subjects with severe arrhythmias (such as ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or atrioventricular block of degree II or above, shown by 12-lead Electrocardiogram (ECG);
  • Subjects with a history of abusing alcohol and illicit drug;
  • Subjects with serious heart disease [New York Heart Association (NYHA) class III-IV];
  • Subjects who are allergic to cattle products;
  • Subjects who participated in other clinical trials in the past 3 months;
  • Subjects with poor compliance and difficult to complete the investigation;
  • Investigators, employees of research centers or family members of them (none of whom are suitable to participate in the trial to ensure the objectivity of the research);
  • Subjects who had an acute exacerbation of IPF or hospitalized for other respiratory diseases 3 or more times in the past 1 year;
  • Subjects who take nintedanib for medication within 1 month, or plan to continue taking nintedanib for medication;
  • Subjects with other acquired or congenital immunodeficiency disorders, or with a history of organ transplantation or cell transplant therapy;
  • Subjects whose expected survival may be less than one year judged by the investigator;
  • Male participants of childbearing potential and female participants within childbearing age were reluctant to use effective contraception from the time of signing the informed consent to 6 months after cell therapy;
  • Subjects assessed as inappropriate to participate in this clinical trial by investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200123

Other trials in China

About this study

Idiopathic pulmonary fibrosis (IPF) is a chronic and ultimately fatal disease characterized by a progressive damage of lung structure and decline in lung function.This study intends to carry out an open, single-center, non-randomized, self control phase I clinical trial. During the treatment, lung stem cells will be isolated from patients' own bronchi and expanded in vitro. Cultured cells will be injected directly into the lesion by fiberoptic bronchoscopy after lavage. After 24-week observation, the investigators will evaluate the safety and efficacy of the treatment by measuring the key clinical indicators.

Being tested
Lung stem cells
Medical subject headings
Idiopathic Pulmonary Fibrosis

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 0.5-5x10^6 (0.5-5 million) /Kg/person cells of clinical grade lung stem cells (LSCs) injected via fiberoptic bronchoscopy after fully lavage of the localized lesions.

Study groups in NCT02745184
Study groupRoleWhat they receive
lung stem cellsExperimentalPatients will receive 0.5-5x10^6 (0.5-5 million)/Kg/person cells of clinical grade lung stem cells (LSCs)injected via fiberoptic bronchoscopy after fully lavage of the localized lesions.
Receives: Biological: Lung stem cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary outcome of the study was the incidence and severity of the cell therapy-related AEs

    To evaluate the safety of the drugs

    Measured: 24 weeks

Secondary outcomes (8)

  1. Incidence of complication related to bronchoscopy

    Measured: 1 week

  2. Evaluation of cell therapy efficacy through DLCO-SB test

    Measured: 24 weeks

  3. exercise tolerance test (6MWD)

    Measured: 24 weeks

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

    Measured: 24 weeks

  5. Change from baseline in forced vital capacity (FVC)

    FVC indicates the volume of air that can forcibly be blown out after full inspiration.

    Measured: 24 weeks

  6. Change from baseline in imaging of lung by high resolution computed tomography (HR-CT)

    Images of lung will be analyzed to indicate the newly-derived pulmonary structure

    Measured: 24 weeks

  7. IPF exacerbation events

    Measured: 24 weeks

  8. Change from baseline in forced expiratory volume in one second (FEV1)

    FEV1 is the volume of breath exhaled with effort in one second.

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2016 (estimated)
  2. Study start30 Mar 2017
  3. Primary completion31 Aug 2020
  4. Study completion31 Aug 2020

Resources

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
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02745184
Sponsor's protocol ID
201602101
Status last verified
Aug 2023
First submitted
15 Apr 2016
Last updated
31 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lung stem cells in people with Idiopathic Pulmonary Fibrosis, 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 8 inclusion and 26 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 31 Aug 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?

The primary outcome of the study was the incidence and severity of the cell therapy-related AEs (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 NCT02745184, 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 31 Aug 2023.

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