Using dead mesenchymal stem cells to treat radiation lung injury

Dead Mesenchymal Stem Cells for the Treatment of Radiation Lung Injury

This study is testing if using dead mesenchymal stem cells can help patients with lung damage caused by radiation therapy feel better.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan University (other)
• Drugs / interventions: radiation
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06021067 on ClinicalTrials.gov

What this trial studies

This clinical trial is a single-center, single-arm, prospective study aimed at evaluating the safety and efficacy of human dead mesenchymal stem cells (hDMSCs) in patients suffering from radiation pneumonitis. Participants will have received chest radiation therapy and will be diagnosed with radiation lung injury based on clinical symptoms and chest CT imaging. The study will follow a dose-escalation design, treating patients with a standard regimen combined with hDMSCs, while monitoring for dose-limiting toxicities over a treatment period of 4 to 6 weeks. The trial does not include a control group with live mesenchymal stem cells.

Who should consider this trial

Good fit: Ideal candidates for this study are patients who have received chest radiation therapy and are diagnosed with grade 2 to 3 radiation lung injury.

Not a fit: Patients with radiation lung injury lasting more than 2 months or those with significant organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients suffering from radiation lung injury, potentially improving their recovery and quality of life.

How similar studies have performed: There are currently no relevant research results from previous human trials using this approach, making it a novel investigation.

Eligibility criteria

Inclusion Criteria:

* Received chest radiotherapy;
* EOCG PS score of 0 to 3 points;
* Diagnosis of radiation lung injury by the attending physician, grade 2 to 3 (according to the CTCAE v5.0 standards);
* Main organs function is normal, that meet the following criteria: blood routine examination (within 7 days of unused hematopoietic growth factors and blood transfusion) : ANC ≥ 1.5 x 10\^9 / L, PLT ≥ 80 x 10\^9 / L, HGB ≥ 80 g/L;Biochemical examination: TBil ≤ 1.5 x ULN (upper limit of normal);ALT or AST ≤ 2.5 x ULN; Creatinine clearance ≥ 60 mL/min (Cockcroft - Gault formula); Blood coagulation function: INR or PT ≤ 1.5 x ULN, if the subjects are receiving anticoagulant therapy, as long as the scope of PT in anticoagulant drugs for it. Heart function examination, electrocardiogram (ECG) normal or abnormal ECG (by the researchers to determine the clinical significance). Heart doppler ultrasound assessment: LVEF ≥ 50%;
* Radiation lung injury lasts less than 2 months；
* Survival expectation ≥6 months;
* Signed and dated written informed consent

Exclusion Criteria:

* Pregnant or lactating women, men and women of childbearing age who are unwilling or unable to take effective contraceptive measures;
* People with a history of chronic bronchitis, emphysema, or cor pulmonale;
* History of lung resection surgery;
* Tumor progression;
* People with severe lung infection;
* Uncontrollable severe systemic diseases (e.g., central nervous system, cardiovascular system, blood system, digestive system, endocrine system, respiratory system, genitourinary system, immune system, etc.) and psychosis;
* Serious cardiovascular events: a period of 6 months in heart failure (NYHA class III level IV), myocardial infarction, unstable angina, severe arrhythmia, cerebral infarction, cerebral hemorrhage;
* Abnormal liver and kidney function: AST and ALT exceed the upper limit of normal by 2.5 times. Serum creatinine is greater than 1.5 mg/dl in men and 1.4 mg/dl in women;
* Co-infection with HIV, Treponema pallidum, tuberculosis, influenza virus, adenovirus and other respiratory infections;
* Hemorrhage or thrombosis, bleeding or anticoagulant drugs;
* Combined with cachexia or other organ failure (requiring organ support);
* Shock or invasive ventilation;
* Combined with pulmonary interstitial pneumonia caused by other reasons or damage, or lung imaging showed radioactive lung injury diagnosed with pulmonary interstitial pneumonia or damage before;
* Patients who have participated in clinical studies of stem cells;
* The investigators believed that there were other reasons why participants were not suitable for the study.

Where this trial is running

Chengdu, Sichuan

• West China Hospital — Chengdu, Sichuan, China (RECRUITING)

Study contacts

• Principal investigator: Zhen-Yu Ding, Prof — Sichuan University
• Study coordinator: Zhen-Yu Ding, Prof

Conditions: Radiation Lung Injury, Dead Mesenchymal Stem Cells, Treatment