ClinicalTrials.gg
Sign In
CompletedNCT02277145Updated Jul 24, 2019

A Study on Radiation-induced Pulmonary Fibrosis Treated With Clinical Grade Umbilical Cord Mesenchymal Stem Cells

A Phase 1 interventional study of clinical grade umbilical cord mesenchymal stem cells in Post-radiotherapy Pulmonary Fibrosis, sponsored by Jianwu Dai. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-07-24.

Sponsored by Jianwu Dai · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Radiation therapy is one of the main means for treating malignant tumor, during which radioactive lung injury is inevitable. Currently there is nearly no effective clinical treatment for late post-radiotherapy pulmonary fibrosis. This study intends to carry out an open, single-center, non-randomized phase I clinical trial. During the treatment, the local lesions will be fully lavaged, and then clinical grade umbilical cord mesenchymal stem cells (MSCs) will be injected directly into the lesion by fiberoptic bronchoscopy. After six-month observation, the investigators will initially evaluate the safety and effectiveness of the treatment by measuring two key indicators-the CT density histogram and the patients' self-evaluation, and one secondary indicator-the changes of TGF-β1 contents, both before and after the treatment. Meanwhile, the investigators will make a preliminary discuss about the possible immunomodulatory effects of the umbilical cord MSCs.

02

Conditions studied

  • Post-radiotherapy Pulmonary Fibrosis

Keywords

  • radiation-induced pulmonary fibrosis
  • MSCs
03

In context

Lead sponsor

Jianwu Dai is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female, 18-70 years old.
  2. Subjects with a clear history of malignancy.
  3. Subjects with a clear history of chest radiation therapy at least 3 months earlier.
  4. Subjects diagnosed as chronic phase of radiation-induced pneumonitis or radiation-induced pulmonary fibrosis stage (see Annex 3 for diagnosis).
  5. Subjects signed informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Women of childbearing age at the stage of pregnancy or lactation, or those without taking effective contraceptive measures.
  2. Subjects with syphilis or HIV positive antibody.
  3. Subjects with infection aggravated within the past month.
  4. Subjects suffering from any of the following pulmonary diseases: active tuberculosis, pulmonary embolism, pneumothorax, multiple huge bullae, uncontrolled asthma, severe pneumonia, acute exacerbation of chronic bronchitis, AECOPD, severe and / or extremely severe COPD, etc..
  5. Subjects suffering from other serious diseases, such as myocardial infarction, unstable angina, cirrhosis, and acute glomerulonephritis.
  6. Subjects with progression-free survival (PFS) less than 0.5 years or Karnofsky performance scores less than 60 points.
  7. Subjects with leukopenia (WBC less than 4x109 / L) or agranulocytosis (WBC less than 1.5x109 / L or neutrophils less than 0.5x109 / L) caused by any reason.
  8. Subjects with severe renal impairment, serum creatinine> 1.5 times the upper limit of normal.
  9. Subjects with liver disease or liver damage: ALT, AST, total bilirubin> 2 times the upper limit of normal
  10. Subjects with a history of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders.
  11. Subjects with severe arrhythmias (such as ventricular tachycardia, frequent superventricular tachycardia, atrial fibrillation, and atrial flutter, etc.) or cardiac degree II or above conduction abnormalities displayed via 12-lead ECG.
  12. Subjects with a history of alcohol or illicit drug abuse.
  13. Subjects accepted by any other clinical trials within 3 months before the enrollment
  14. Subjects with poor compliance, difficult to complete the study.
  15. Any other conditions that might increase the risk of subjects or interfere with the clinical trial.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    treatment group

    Patients will receive 10\^6 (1 million) /Kg/person cells of clinical grade umbilical cord mesenchymal stem cells (MSCs) injected via fiberoptic bronchoscopy after fully lavage of the localized lesions

    Biological: clinical grade umbilical cord mesenchymal stem cells

Interventions

  • Biologicalclinical grade umbilical cord mesenchymal stem cells

    10\^6 (1 million) /Kg/person cells of clinical grade umbilical cord MSCs will be injected after fully lavage of the localized lesions

06

What researchers measure

Primary outcomes

  1. Composite indicators, including quantitative analysis of CT density histograms, self-evaluation and changes of TGF-β1 content

    Different proportions will be assigned to the three indicators. The overall curative effect can be judged with scores ranging from 0 to100. Specific proportions are as follows: full scores of 50 points for image changes, 25 for self-efficacy evaluation and 25 for TGF-β1 content changes. The image changes can be classified into four levels: significant control, improved, stable, and progressive; the self-efficacy evaluation can also be classified into four levels: effective, improved, stable and invalid; the changes of TGF-β1 content will be classified into three levels: improved, stable, and progressive. The four levels will be scored on the ratio of 5:4:3:1, the three levels will be scored on the ratio of 5:3:1.

    Time frame: 6 months

  2. Safety Evaluation

    Clinical adverse events evaluated as definitely/ probably/possibly concerned with stem cell therapy in this trial and abnormal results of laboratory tests or other special examinations will be observed and recorded in detail.

    Time frame: 6 months

Secondary outcomes

  1. Clinical Indicator 1: change in blood gas analysis

    Time frame: 3-6 months

  2. Clinical Indicator 2: change in pulmonary function analysis

    Time frame: 3-6 months

  3. Clinical Indicator 3: 6-minute walk test distance

    Time frame: 3-6 months

  4. Clinical Indicator 4: change in MRC chronic dyspnea scale

    Time frame: 3-6 months

  5. Clinical Indicator 5: change in St. George's Respiratory Questionnaire (SGRQ) scale

    Time frame: 3-6 months

  6. Immunological Indicator in serum 1: T lymphocyte counts in peripheral blood

    Cellular immunological indicator: T lymphocyte counts in peripheral blood measured in serum

    Time frame: 3-6 months

  7. Immunological Indicator in serum 2: response level of CD4+ T lymphocyte subsets (such as Th1 / Th2)

    Cellular immunological indicator: response level of CD4+ T lymphocyte subsets (such as Th1 / Th2) measured in serum

    Time frame: 3-6 months

  8. Immunological Indicator in serum 3: concent of immunoglobulin

    Humoral immunological indicator: concent of immunoglobulin measured in serum

    Time frame: 3-6 months

  9. Immunological Indicator in serum 4: expression levels of various cytokines (IL-1, IL-3, IL-6, IL-8, TNF-α, GM-CSF, etc)

    Humoral immunological indicator: expression levels of various cytokines in serum (IL-1, IL-3, IL-6, IL-8, TNF-α, GM-CSF, etc) measured in serum

    Time frame: 3-6 months

  10. Immunological Indicator in serum 5: subtype analysis and phagocytic activity analysis of macrophage

    Macrophage-related polarization indicator: subtype analysis and phagocytic activity of macrophage measured in serum

    Time frame: 3-6 months

  11. Immunological Indicator in serum 6: expression levels of IL-12, IL-10

    Macrophage- related polarization indicators: expression levels of IL-12, IL-10 measured in serum

    Time frame: 3-6 months

  12. Immunological Indicator in lavage fluid 1: T lymphocyte counts in peripheral blood

    Cellular immunological indicator: T lymphocyte counts in peripheral blood measured in lavage fluid

    Time frame: 6 months

  13. Immunological Indicator in lavage fluid 2: response level of CD4+ T lymphocyte subsets (such as Th1 / Th2)

    Cellular immunological indicator: response level of CD4+ T lymphocyte subsets (such as Th1 / Th2) measured in lavage fluid

    Time frame: 6 months

  14. Immunological Indicator in lavage fluid 3: concent of immunoglobulin

    Humoral immunological indicator: concent of immunoglobulin measured in lavage fluid

    Time frame: 6 months

  15. Immunological Indicator in lavage fluid 4: expression levels of various cytokines (IL-1, IL-3, IL-6, IL-8, TNF-α, GM-CSF, etc)

    Humoral immunological indicator: expression levels of various cytokines (IL-1, IL-3, IL-6, IL-8, TNF-α, GM-CSF, etc) measured in lavage fluid

    Time frame: 6 months

  16. Immunological Indicator in lavage fluid 5: subtype analysis and phagocytic activity analysis of macrophage

    Macrophage-related polarization indicator: subtype analysis and phagocytic activity of macrophage measured in lavage fluid

    Time frame: 6 months

  17. Immunological Indicator in lavage fluid 6: expression levels of IL-12, IL-10

    Macrophage-related polarization indicators: expression levels of IL-12, IL-10 measured in lavage fluid

    Time frame: 6 months

  18. Inflammatory Indicators: measured by routine blood test including C-reactive protein (CRP)

    Time frame: 3 months

  19. Fibrosis Indicators in serum 1: content of transforming growth factor -α/β (TGF-α/TGF-β)

    Content of transforming growth factor α/β (TGF-α/TGF-β) measured in serum

    Time frame: 3-6 months

  20. Fibrosis Indicators in serum 2: content of hydroxyproline

    Content of hydroxyproline measured in serum

    Time frame: 3-6 months

  21. Fibrosis Indicators in serum 3: content of matrix metalloproteinase 1/7(MMP1/MMP7)

    Content of matrix metalloproteinase 1/7(MMP1/MMP7) measured in serum

    Time frame: 3-6 months

  22. Fibrosis Indicators in lavage fluid 1: content of transforming growth factor -α/β (TGF-α/TGF-β)

    Content of transforming growth factor -α/β (TGF-α/TGF-β) measured in lavage fluid

    Time frame: 6 months

  23. Fibrosis Indicators in lavage fluid 2: content of hydroxyproline

    Content of hydroxyproline measured in lavage fluid measured in lavage fluid

    Time frame: 6 months

  24. Fibrosis Indicators in lavage fluid 3: content of matrix metalloproteinase 1/7(MMP1/MMP7)

    Content of matrix metalloproteinase 1/7(MMP1/MMP7) measured in lavage fluid

    Time frame: 6 months

07

Study locations

1 site
  • First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)
    Chongqing, Chongqing Municipality 400038, China
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2014, a primary completion of Dec 2018 and a completion of Dec 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 20, 2014
First posted
Oct 28, 2014
Start
Oct 2014
Primary completionActual
Dec 2018
CompletionActual
Dec 2018
Last update
Jul 24, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02277145
Lead sponsor
Jianwu Dai
Collaborators
Southwest Hospital, China
Responsible party
Jianwu Dai (Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS, Chinese Academy of Sciences) — Sponsor-investigator
First posted
Oct 28, 2014
Start date
Oct 2014
Primary completion
Dec 2018
Completion
Dec 2018
Last update
Jul 24, 2019

Study contacts

JianWu Dai, Ph.D
principal investigator · Chinese Academy of Sciences
Wei Xiong, M.D
study chair · First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)
Xiaotian Dai, M.M
study director · First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Jianwu Dai

Start the discussion