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Radiation Lung InjuryPhase 1/2NCT06021067

Dead Mesenchymal Stem Cells for Radiation Lung Injury

A Phase 1/2 study testing Death mesenchymal stem cell in people with Radiation Lung Injury, run by Sichuan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Radiation Lung Injury
What is being tested?
Death mesenchymal stem cell
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
10 Sep 2023to 30 Sep 2024
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Zhen-Yu Ding, Prof contact

86-028-85423609

dingzhenyu@scu.edu.cn

China1 site, 1 recruiting

  • West China Hospital

    Chengdu, Sichuan, 610000

    Zhen-Yu Ding, Prof, 0086288542357, dignzhenyu@scu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Dead Mesenchymal Stem Cells for the Treatment of Radiation Lung Injury

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.

Read the 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 1×10^5/pc/30g, that is, the effective dose of mice is 3.3×10^6/kg. The dose of mice is 10 times that of humans, and the effective dose of humans is 3.3×10^5/kg. Therefore, the clinical effective dose of 60kg patients is 2.0×10^7, 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.

Being tested
Death mesenchymal stem cell
Keywords
Dead Mesenchymal Stem Cells, Radiation Lung Injury, Treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Death mesenchymal stem cellBiological

    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.

Study groups in NCT06021067
Study groupRoleWhat they receive
Death mesenchymal stem cell therapy plus standard treatment for radiation pneumoniaExperimentalSubjects (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.
Receives: Biological: Death mesenchymal stem cell

What is being measured

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

  1. The number of adverse events

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

    Measured: up to 1 year

Secondary outcomes (5)

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

    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.

    Measured: up to 1 year

  2. Blood gas analysis will be performed after 1 month of dead mesenchymal stem cell injection.

    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.

    Measured: up to 1 year

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

    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.

    Measured: up to 1 year

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

    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.

    Measured: up to 1 year

  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.

    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.

    Measured: up to 1 year

Timeline

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

  1. First posted1 Sep 2023
  2. Study start10 Sep 2023 (estimated)
  3. Primary completion10 Sep 2024 (estimated)
  4. Study completion30 Sep 2024 (estimated)

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
Model description
one-arm study
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06021067
Sponsor's protocol ID
RLI2023
Status last verified
Aug 2023
First submitted
24 Jun 2023
Last updated
1 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alfouzan AF. Radiation therapy in head and neck cancer. Saudi Med J. 2021 Mar;42(3):247-254. doi: 10.15537/smj.2021.42.3.20210660.

    PubMed 33632902

  • Bracci S, Valeriani M, Agolli L, De Sanctis V, Maurizi Enrici R, Osti MF. Renin-Angiotensin System Inhibitors Might Help to Reduce the Development of Symptomatic Radiation Pneumonitis After Stereotactic Body Radiotherapy for Lung Cancer. Clin Lung Cancer. 2016 May;17(3):189-97. doi: 10.1016/j.cllc.2015.08.007. Epub 2015 Aug 29.

    PubMed 26427647

  • Giuranno L, Ient J, De Ruysscher D, Vooijs MA. Radiation-Induced Lung Injury (RILI). Front Oncol. 2019 Sep 6;9:877. doi: 10.3389/fonc.2019.00877. eCollection 2019.

    PubMed 31555602

  • Chun SG, Hu C, Choy H, Komaki RU, Timmerman RD, Schild SE, Bogart JA, Dobelbower MC, Bosch W, Galvin JM, Kavadi VS, Narayan S, Iyengar P, Robinson CG, Wynn RB, Raben A, Augspurger ME, MacRae RM, Paulus R, Bradley JD. Impact of Intensity-Modulated Radiation Therapy Technique for Locally Advanced Non-Small-Cell Lung Cancer: A Secondary Analysis of the NRG Oncology RTOG 0617 Randomized Clinical Trial. J Clin Oncol. 2017 Jan;35(1):56-62. doi: 10.1200/JCO.2016.69.1378. Epub 2016 Oct 31.

    PubMed 28034064

  • Madan R, Benson R, Sharma DN, Julka PK, Rath GK. Radiation induced heart disease: Pathogenesis, management and review literature. J Egypt Natl Canc Inst. 2015 Dec;27(4):187-93. doi: 10.1016/j.jnci.2015.07.005. Epub 2015 Aug 18.

    PubMed 26296945

  • Palma DA, Olson R, Harrow S, Gaede S, Louie AV, Haasbeek C, Mulroy L, Lock M, Rodrigues GB, Yaremko BP, Schellenberg D, Ahmad B, Senthi S, Swaminath A, Kopek N, Liu M, Moore K, Currie S, Schlijper R, Bauman GS, Laba J, Qu XM, Warner A, Senan S. Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastatic Cancers: Long-Term Results of the SABR-COMET Phase II Randomized Trial. J Clin Oncol. 2020 Sep 1;38(25):2830-2838. doi: 10.1200/JCO.20.00818. Epub 2020 Jun 2.

    PubMed 32484754

  • Jain V, Berman AT. Radiation Pneumonitis: Old Problem, New Tricks. Cancers (Basel). 2018 Jul 3;10(7):222. doi: 10.3390/cancers10070222.

    PubMed 29970850

  • Maria OM, Maria AM, Ybarra N, Jeyaseelan K, Lee S, Perez J, Shalaby MY, Lehnert S, Faria S, Serban M, Seuntjens J, El Naqa I. Mesenchymal Stem Cells Adopt Lung Cell Phenotype in Normal and Radiation-induced Lung Injury Conditions. Appl Immunohistochem Mol Morphol. 2016 Apr;24(4):283-95. doi: 10.1097/PAI.0000000000000180.

    PubMed 26200842

  • Perez JR, Ybarra N, Chagnon F, Serban M, Lee S, Seuntjens J, Lesur O, El Naqa I. Tracking of Mesenchymal Stem Cells with Fluorescence Endomicroscopy Imaging in Radiotherapy-Induced Lung Injury. Sci Rep. 2017 Jan 19;7:40748. doi: 10.1038/srep40748.

    PubMed 28102237

  • Lee KC, Lin HC, Huang YH, Hung SC. Allo-transplantation of mesenchymal stem cells attenuates hepatic injury through IL1Ra dependent macrophage switch in a mouse model of liver disease. J Hepatol. 2015 Dec;63(6):1405-12. doi: 10.1016/j.jhep.2015.07.035. Epub 2015 Aug 11.

    PubMed 26276675

  • Islam D, Huang Y, Fanelli V, Delsedime L, Wu S, Khang J, Han B, Grassi A, Li M, Xu Y, Luo A, Wu J, Liu X, McKillop M, Medin J, Qiu H, Zhong N, Liu M, Laffey J, Li Y, Zhang H. Identification and Modulation of Microenvironment Is Crucial for Effective Mesenchymal Stromal Cell Therapy in Acute Lung Injury. Am J Respir Crit Care Med. 2019 May 15;199(10):1214-1224. doi: 10.1164/rccm.201802-0356OC.

    PubMed 30521764

  • Duan X, Lu L, Wang Y, Zhang F, Mao J, Cao M, Lin B, Zhang X, Shuai X, Shen J. The long-term fate of mesenchymal stem cells labeled with magnetic resonance imaging-visible polymersomes in cerebral ischemia. Int J Nanomedicine. 2017 Sep 8;12:6705-6719. doi: 10.2147/IJN.S146742. eCollection 2017.

    PubMed 28932115

  • Bruder SP, Jaiswal N, Ricalton NS, Mosca JD, Kraus KH, Kadiyala S. Mesenchymal stem cells in osteobiology and applied bone regeneration. Clin Orthop Relat Res. 1998 Oct;(355 Suppl):S247-56. doi: 10.1097/00003086-199810001-00025.

    PubMed 9917644

  • Zhou Y, Yamamoto Y, Xiao Z, Ochiya T. The Immunomodulatory Functions of Mesenchymal Stromal/Stem Cells Mediated via Paracrine Activity. J Clin Med. 2019 Jul 12;8(7):1025. doi: 10.3390/jcm8071025.

    PubMed 31336889

  • Song N, Scholtemeijer M, Shah K. Mesenchymal Stem Cell Immunomodulation: Mechanisms and Therapeutic Potential. Trends Pharmacol Sci. 2020 Sep;41(9):653-664. doi: 10.1016/j.tips.2020.06.009. Epub 2020 Jul 22.

    PubMed 32709406

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Death mesenchymal stem cell in people with Radiation Lung Injury, run by Sichuan University 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 7 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 1 Sep 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhen-Yu Ding, Prof (86-028-85423609, dingzhenyu@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of adverse events (time frame: up to 1 year). 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 NCT06021067, which also lists 25 linked publications.

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 1 Sep 2023.

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