Radiation-induced Lung InjuryEarly Phase 1NCT07177456
Study on Safety and Efficacy of UCB-MNCs for Radiation-induced Lung Injury
A Early Phase 1 study testing UCB-MNCs in people with Radiation-induced Lung Injury, run by Zhejiang Cancer Hospital.
Trial summary
This study aims to evaluate the safety and efficacy of the umbilical cord blood mononuclear cells (UCB-MNCs) therapy for radiation-induced lung injuryr (RILI) by observing factors related to the therapeutic effect and adverse reactions of UCB-MNCs in treating RILI . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Radiation-induced Lung Injury
- What is being tested?
- UCB-MNCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-75 years,with no restriction on gender;
- History of chest radiotherapy;
- Diagnosed with grade 2-3 radiation-induced lung injury according to CTCAE 4.0 classification criteria in "Diagnosis and Treatment of Radiation-induced Lung Injury";
- Inadequate response to conventional treatment for two weeks, with no relief or progressive worsening of symptoms;
- Well-controlled tumor for ≥3 months;
- No significant liver or kidney dysfunction: ALT, AST ≤ 3 times the upper limit of normal, serum Cr and BUN ≤ 2 times the upper limit of normal;
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- Expected survival ≥ 3 months;
- Informed consent signed voluntarily by the patient;
- Willing and able to receive treatment and follow-up as required by the protocol, and able to comply with basic treatment as directed by the physician.
Who cannot join
- Severe cardiac insufficiency (such as NYHA class III or IV), uncontrolled hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥110mmHg);
- Positive for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or syphilis;
- ECOG score ≥2;
- Currently participating in or participated in other clinical trials within 4 weeks;
- History of allergies or known allergy to the study preparation;
- Patients with psychiatric disorders who cannot cooperate with treatment; (7) Pregnant or lactating women.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study on the Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in the Treatment of Radiation-induced Lung Injury
This study aims to evaluate the safety and efficacy of the umbilical cord blood mononuclear cells (UCB-MNCs) therapy for radiation-induced lung injuryr (RILI) by observing factors related to the therapeutic effect and adverse reactions of UCB-MNCs in treating RILI .
- Conditions
- Radiation-induced Lung Injury
- Being tested
- UCB-MNCs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCB-MNCsBiological
UCB-MNCs were administered via intravenous infusion three times, once per week, with a dose of 3×10⁸ cells per infusion.
| Study group | Role | What they receive |
|---|---|---|
| UCB-MNCs | Experimental | UCB-MNCs are obtained from umbilical cord blood by density gradient centrifugation Receives: Biological: UCB-MNCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest Enhanced CT Scan report
Evaluate changes in lung damage ，and calculate the change in total lesion volume as a percentage of total lung volume.
Measured: Baseline and at 1、3、6 and 12 months after the last treatment.
Secondary outcomes (10)
Modified Medical Research Council Dyspnea Scale (mMRC Score)
mMRC Score is a subjective scale for assessing the severity of breathing difficulties,dyspnea is classified into five grades (0 to 4). The higher the grade, the more severe the symptoms and the more obvious the limitation of movement.
Measured: Baseline and at 1、3 、6 and 12 months after the last treatment.
6-minute walking distance test（6MWT）
The 6-minute walking distance (6MWD) is a method for assessing a patient's cardiopulmonary function and exercise endurance by measuring the maximum distance they can walk as fast as possible within 6 minutes.
Measured: Baseline and at 1、3 、6 and 12 months after the last treatment.
Change from baseline in forced expiratory volume in 1st second (FEV1)
FEV1 is the maximal volume of air that can be expired in 1st second of forced vital capacity maneuver using spirometry.
We measured FEV1 at baseline and at 1、3 、6 months and 12 months after the last treatment.
Measured: We measured FEV1 at baseline and at 1、3 、6 months and 12 months after the last treatment.
Change from baseline in forced vital capacity (FVC)
Forced vital capacity (FVC) is the maximal volume of air that can be expired while patient performs forced expiration as fast and as deep as possible using spirometry.
We measured FEV1 at baseline and at 1、3 、6 months and 12 months after the last treatment.
Measured: We measured FVC at baseline and at 1、3 、6 months and 12 months after the last treatment.
Change from baseline in FEV1/FVC ratio
FEV1/FVC is used to differentiate obstructive from restrictive patterns by spirometry.
We measuredFEV1/ FVC at baseline and at 1、3 、6 months and 12 months after the last treatment.
Measured: We measuredFEV1/ FVC at baseline and at 1、3 、6 months and 12 months after the last treatment.
Change from baseline in lung Carbon Monoxide Diffusion Capacity (DLCO)
DLCO will be measured using the single breath-hold method with a Quark PFT gas analyzer, following ATS/ERS standards. Each test involves inhalation of a gas mixture (0.3% CO, 0.3% CH4, and dry air), breath-holding for 10±2 seconds, and exhalation.
We measured DLCO at baseline and at 1、3 、6 months and 12 months after the last treatment.
Measured: We measured DLCO at baseline and at 1、3 、6 months and 12 months after the last treatment.
Arterial blood gas parameter like pH value
Compare pH value at baseline and at 1、3 、6 months and 12 months after the last treatment.
Measured: We measured pH value at baseline and at 1、3 、6 months and 12 months after the last treatment.
Arterial blood gas parameter like partial pressure of oxygen (PO2)
Compare the partial pressure of oxygen (PO2) at baseline and at 1、3 、6 months and 12 months after the last treatment.
Measured: We measured PO2 at baseline and at 1、3 、6 months and 12 months after the last treatment.
Arterial blood gas parameter like oxygen saturation (SO2)
Compare the oxygen saturation (SO2) at baseline and at 1、3 、6 months and 12 months after the last treatment.
Measured: We measured SO2 at baseline and at 1、3 、6 months and 12 months after the last treatment.
Arterial blood gas parameter like partial pressure of carbon dioxide (PCO2)
Compare the partial pressure of carbon dioxide (PCO2) at baseline and at 1、3 、6 months and 12 months after the last treatment.
Measured: We measured PCO2 at baseline and at 1、3 、6 months and 12 months after the last treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-induced Lung InjuryStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Zhu, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177456
- Sponsor's protocol ID
- 2025&UCB-MNCs&RILI
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in the Treatment of Radiation-induced Lung Injury
- ClinicalTrials.gov ID
- NCT07177456
- Acronym / sponsor ID
- 2025&UCB-MNCs&RILI
- Conditions
- Radiation-induced Lung Injury
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Sep 2025 (actual)
- 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.
This study aims to evaluate the safety and efficacy of the umbilical cord blood mononuclear cells (UCB-MNCs) therapy for radiation-induced lung injuryr (RILI) by observing factors related to the therapeutic effect and adverse reactions of UCB-MNCs in treating RILI .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UCB-MNCs | Experimental | Biological: UCB-MNCsUCB-MNCs are obtained from umbilical cord blood by density gradient centrifugation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ages 18-75 years,with no restriction on gender;
- History of chest radiotherapy;
- Diagnosed with grade 2-3 radiation-induced lung injury according to CTCAE 4.0 classification criteria in "Diagnosis and Treatment of Radiation-induced Lung Injury";
- Inadequate response to conventional treatment for two weeks, with no relief or progressive worsening of symptoms;
- Well-controlled tumor for ≥3 months;
Key exclusion criteria (6 listed)
- Severe cardiac insufficiency (such as NYHA class III or IV), uncontrolled hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥110mmHg);
- Positive for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or syphilis;
- ECOG score ≥2;
- Currently participating in or participated in other clinical trials within 4 weeks;
- History of allergies or known allergy to the study preparation;
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 |
|---|---|---|
| UCB-MNCsUCB-MNCs were administered via intravenous infusion three times, once per week, with a dose of 3×10⁸ cells per infusion. | Biological | UCB-MNCs |
Primary outcome
Chest Enhanced CT Scan report
Time frame: Baseline and at 1、3、6 and 12 months after the last treatment.
Evaluate changes in lung damage ，and calculate the change in total lesion volume as a percentage of total lung volume.
10 secondary outcomes
Modified Medical Research Council Dyspnea Scale (mMRC Score)
Time frame: Baseline and at 1、3 、6 and 12 months after the last treatment.
6-minute walking distance test（6MWT）
Time frame: Baseline and at 1、3 、6 and 12 months after the last treatment.
Change from baseline in forced expiratory volume in 1st second (FEV1)
Time frame: We measured FEV1 at baseline and at 1、3 、6 months and 12 months after the last treatment.
Change from baseline in forced vital capacity (FVC)
Time frame: We measured FVC at baseline and at 1、3 、6 months and 12 months after the last treatment.
Change from baseline in FEV1/FVC ratio
Time frame: We measuredFEV1/ FVC at baseline and at 1、3 、6 months and 12 months after the last treatment.
Change from baseline in lung Carbon Monoxide Diffusion Capacity (DLCO)
Time frame: We measured DLCO at baseline and at 1、3 、6 months and 12 months after the last treatment.
Arterial blood gas parameter like pH value
Time frame: We measured pH value at baseline and at 1、3 、6 months and 12 months after the last treatment.
Arterial blood gas parameter like partial pressure of oxygen (PO2)
Time frame: We measured PO2 at baseline and at 1、3 、6 months and 12 months after the last treatment.
Arterial blood gas parameter like oxygen saturation (SO2)
Time frame: We measured SO2 at baseline and at 1、3 、6 months and 12 months after the last treatment.
Arterial blood gas parameter like partial pressure of carbon dioxide (PCO2)
Time frame: We measured PCO2 at baseline and at 1、3 、6 months and 12 months after the last treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing UCB-MNCs in people with Radiation-induced Lung Injury, run by Zhejiang Cancer Hospital.
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 9 inclusion and 6 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: opening soon, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ji ZHU (0571-88128212, zhuji@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest Enhanced CT Scan report (time frame: Baseline and at 1、3、6 and 12 months after the last treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2025.