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Dead Mesenchymal Stem Cells for Radiation Lung Injury

Sponsor
Sichuan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06021067
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
12.7
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this single center, single arm and prospective study is to explore the safety and efficacy of hDMSCs in the treatment of radiation pneumonitis.

Condition or Disease Intervention/Treatment Phase
  • Biological: Death mesenchymal stem cell
 Phase 1/Phase 2

Detailed Description

As a single-center, single-arm, prospective clinical trial, this study aims to explore the safety and efficacy of hDMSCs in the treatment of radiation pneumonia. This study will include patients who have received chest radiation therapy and are diagnosed with radiation lung injury based on clinical manifestations and changes in chest CT imaging. The degree of lung injury is graded according to CTCAE v5.0 criteria, and the corresponding standard treatment is received according to its grade. Using the 3+3 design for dose climbing, according to the order of patient inclusion, the first 3 patients (cohort 1) are treated with a standard treatment regimen combined with a pre-specified starting dose of dead mesenchymal stem cells (this study does not set up a live MSC group as a control). There are currently no relevant research results of previous human trials. The starting dose is obtained by our preclinical research. The mouse dose is 1×105/pc/30g, that is, the effective dose of mice is 3.3×106/kg. The dose of mice is 10 times that of humans, and the effective dose of humans is 3.3×105/kg. Therefore, the clinical effective dose of 60kg patients is 2.0×107, infusion every 3 days, continuous infusion 4 times, treatment duration of 4~6 weeks. During the dose-limited toxicity (DLT) observation period (30 days), observe the number of cases of DLT in 3 patients to determine whether to maintain the current dose group or adjust the dose group. If the dose of dead mesenchymal stem cells needs to be increased, the dose is ramped up by 3 times the starting dose (i.e., the second gradient dose is 6.0×10^7) until the number of patients in either dose group reaches 6 or the dose group adjustment is not possible. To determine the optimal therapeutic dose for the treatment of radiation lung injury using death mesenchymal stem cells in combination with standard therapy. A total of 15 patients were planned to be included in this study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
one-arm studyone-arm study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Dead Mesenchymal Stem Cells for the Treatment of Radiation Lung Injury
Anticipated Study Start Date :
Sep 10, 2023
Anticipated Primary Completion Date :
Sep 10, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Death mesenchymal stem cell therapy plus standard treatment for radiation pneumonia

Subjects (n=3) received a standard treatment regimen combined with a pre-specified starting dose of dead mesenchymal stem cells (2.0×10^7 for 60kg patient), infusion every 3 days, continuous infusion 4 times, treatment duration is 4~6 weeks. . If dose-limiting toxicity (DLT) does not occur within 30 days of the first administration, the dose is escalated by three times.

Biological: Death mesenchymal stem cell
A standard treatment regimen combined with a pre-specified starting dose of dead mesenchymal stem cells (2.0×10^7 for 60kg patient), infusion every 3 days, continuous infusion 4 times, treatment duration is 4~6 weeks.

Outcome Measures

Primary Outcome Measures

  1. The number of adverse events [up to 1 year]

    The number of adverse events occurring within a given time frame will be reported according to CTCAE v5.0 to assess overall safety.

Secondary Outcome Measures

  1. Chest contrast-enhanced CT will be used to assess changes in lung injury after treatment [up to 1 year]

    Chest contrast-enhanced CT will be performed at 1, 2, 3, 6, and 12 months after completion of dead mesenchymal stem cell injection, and the change in the proportion of total lesions to total lung volume will be calculated, i.e., (proportion of total lesions to total lung volume - proportion of total lesions to total lung volume at baseline) / proportion of total lesions to total lung volume at baseline.

  2. Blood gas analysis will be performed after 1 month of dead mesenchymal stem cell injection. [up to 1 year]

    At 1 month after completion of the injection of dead mesenchymal stem cells, changes in blood gas analysis will be observed to assess lung function.

  3. Pulmonary function test will be performed after 1, 2, 3, 6, 12month of dead mesenchymal stem cell injection. [up to 1 year]

    At after 1, 2, 3, 6, 12month completion of the injection of dead mesenchymal stem cells, pulmonary function test will be performed to assess recovery of lung function.

  4. 6-minute walking tests will be performed after 1, 2, 3, 6, 12month of dead mesenchymal stem cell injection. [up to 1 year]

    At 1, 2, 3, 6 and 12 months after the completion of dead mesenchymal stem cell therapy, 6-minute walking tests will be performed to evaluate the recovery of the subjects' cardiopulmonary condition.

  5. St. George's Respiratory Questionnaire will be completed to estimate the quality of life after 1, 2, 3, 6, 12month of dead mesenchymal stem cell injection. [up to 1 year]

    At 1, 2, 3, 6 and 12 months after the completion of dead mesenchymal stem cell therapy, St. George's Respiratory Questionnaire will be completed to evaluate the subjects' quality of life.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 109 / L, PLT ≥ 80 x 109 / 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 West China Hospital Chengdu Sichuan China 610000

Sponsors and Collaborators

  • Sichuan University

Investigators

  • Principal Investigator: Zhen-Yu Ding, Prof, Sichuan University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Zhen-Yu Ding, Professor, Sichuan University
ClinicalTrials.gov Identifier:
NCT06021067
Other Study ID Numbers:
  • RLI2023
First Posted:
Sep 1, 2023
Last Update Posted:
Sep 1, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zhen-Yu Ding, Professor, Sichuan University
Dead Mesenchymal Stem Cells
Radiation Lung Injury
Treatment
Additional relevant MeSH terms:
Lung Injury
Wounds and Injuries

Study Results

No Results Posted as of Sep 1, 2023