Interstitial Lung DiseasePhase 1NCT06534528
Human Umbilical Cord Mesenchymal Stem Cell Injection for the Treatment of Interstitial Lung Disease
A Phase 1 study testing Human umbilical cord mesenchymal stem cell injection in people with Interstitial Lung Disease, run by Shanghai Life Science & Technology.
Trial summary
Main objective: To explore the safety and tolerability of human umbilical cord mesenchymal stem cell injection in the treatment of interstitial lung disease (ILD); Secondary objective: To explore the preliminary effectiveness of human umbilical cord mesenchymal stem cell therapy for interstitial lung disease (ILD) and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Human umbilical cord mesenchymal stem cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Oct 2027
- Phase
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gender not limited, age ≥ 18 years old (including threshold);
- Clinical diagnosis of interstitial lung disease;
- Blood biochemistry tests must meet the following criteria: alanine aminotransferase (ALT) ≤ 2.5 × ULN, aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin (TBIL) ≤ 2 × ULN, direct bilirubin (DBIL) ≤ 1.5 × ULN, or creatinine (Cr) ≤ 3 × ULN;
- The diffusion capacity of carbon monoxide (DLCO) (corrected by Hb) in lung function tests within the previous 3 months is 30% to 80% of the expected value (including 30% and 80%); Forced vital capacity (FVC) is 40% to 70% of the estimated value (including 40% and 70%)
Who cannot join
- Within the first 3 days of enrollment, use high-dose corticosteroids (equivalent to methylprednisolone>240 mg/day) or irregularly use systemic corticosteroids;
- For patients receiving immunosuppressive therapy, unstable background treatment with cyclophosphamide, mycophenolate mofetil/sodium, methotrexate, or other immunosuppressive monotherapy is not allowed (combination therapy is not allowed)
- Diagnose IPF patients who have previously taken drugs that may cause or worsen pulmonary fibrosis;
- Individuals with a history of mechanical ventilation or concurrent infectious pneumonia or asthma within the previous month prior to screening; Patients with airway obstruction disease (FEV1/FVC<0.7 before using bronchodilators); Patients with other clinically significant serious abnormalities in the lungs; Currently requiring oxygen therapy treatment (oxygen therapy time>15h/d);
- Pregnant and lactating women
- Screening for malignant tumors that have occurred within the past 5 years, excluding cervical carcinoma in situ, squamous cell carcinoma of the skin, or basal cell carcinoma that have been previously treated for curative purposes;
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- Individuals who have been hospitalized for 3 or more times due to acute exacerbation of ILD or other respiratory diseases within the past year prior to screening
- There is evidence that subjects currently have digestive system, urinary system, cardio cerebrovascular, blood system, nervous system, mental and metabolic diseases that may affect safety, such as type 2 diabetes with poor blood sugar control, hypertension with poor blood pressure control, etc
- have a history of abuse or drug use of psychotropic substances
- individuals allergic to human serum albumin, anesthetics, or their components
- Select participants who have participated in any other clinical trials within the previous 3 months;
- individuals who have previously received stem cell therapy
- Researchers have determined that the expected survival period may be less than 1 year;
- Subjects who cannot tolerate bronchoscopy examination (including but not limited to: active massive hemoptysis; severe hypertension and arrhythmia;
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: An Open Clinical Study Exploring the Safety, Tolerability, and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Interstitial Lung Disease (ILD)
Main objective: To explore the safety and tolerability of human umbilical cord mesenchymal stem cell injection in the treatment of interstitial lung disease (ILD); Secondary objective: To explore the preliminary effectiveness of human umbilical cord mesenchymal stem cell therapy for interstitial lung disease (ILD) and recommend appropriate cell therapy doses for subsequent clinical studies; Exploring the immunogenicity of human umbilical cord mesenchymal stem cell injection in the treatment of interstitial lung disease (ILD).
- Conditions
- Interstitial Lung Disease
- Being tested
- Human umbilical cord mesenchymal stem cell injection
- Keywords
- Interstitial Lung Disease, ILD
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human umbilical cord mesenchymal stem cell injectionDrug
Different doses of human umbilical cord mesenchymal stem cell injection were infused to the focus of patients with idiopathic pulmonary fibrosis through bronchoscope, and the tolerance of subjects to different doses of human umbilical cord mesenchymal stem cell injection was observed, and the curative effect was preliminarily observed.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | Four different doses were set, and three subjects in each dose plan received human umbilical cord mesenchymal stem cell injection successively. Each subject received a single dose of 6.0*10^6, 3.0*10^7,6.0*10^7, and 9.0*10^7 cells / person. Receives: Drug: Human umbilical cord mesenchymal stem cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose per dose (MTD)
The maximum tolerable dose (MTD) of a single administration depends on whether dose limiting toxicity (DLT) occurs within 4 weeks after the first administration, for example (1) Hematological toxicity of grade 3 and above caused by the treatment of human umbilical cord mesenchymal stem cell injection. There are grade 3 and above non hematological toxic reactions caused by the treatment of human umbilical cord mesenchymal stem cell injection, except for the following cases, (3) Any other toxicity related to cell therapy that is higher than the baseline level is judged as clinically significant and / or unacceptable by the investigator and the sponsor, (4) There are acute exacerbations and serious adverse events (SAE) of IPF related to the treatment of human umbilical cord mesenchymal stem cell injection (which may be related, likely to be related and definitely related)
Measured: From the first administration to 4 weeks after administration
Secondary outcomes (16)
Preliminary efficacy evaluation：lung function
Changes from baseline in lung function (forced vital capacity, diffusion capacity for carbon monoxide) in the treatment of Interstitial lung disease(ILD), and to recommend the appropriate dose of cell therapy for subsequent clinical studies.
Forced vital capacity(FVC) in litre(L); Diffusion capacity for carbon monoxide(DLCO) in ml/min/mmHg
Measured: The 4th, 12th, 24th week after administration
Preliminary efficacy evaluation: St. George's respiratory questionnaire(SGRQ)
Changes from baseline in score of St. George's respiratory questionnaire(SGRQ). To study the value of St George s respiratory questionnaire(SGRQ) in evaluating the life quality of patients with ILD, and to recommend the appropriate dose of cell therapy for subsequent clinical studies.
St. George's respiratory questionnaire(SGRQ) score: Range 0-100,The higher the score, the more severe the impact of the disease on symptoms, activities, and daily life.
Measured: The 4th, 12th, 24th week after administration
Preliminary efficacy evaluation: dyspnea score
Changes from baseline in value of dyspnea score. To study the value of dyspnea score(modified Medical Research Council, mMRC) in evaluating the life quality of patients with ILD, and to recommend the appropriate dose of cell therapy for subsequent clinical studies.
Dyspnea score(mMRC)：Range 0-4,mMRC levels 0-1 indicate few symptoms, mMRC levels 2-3 indicate multiple symptoms, and level 4 indicates difficulty breathing at the slightest level of activity.
Measured: The 4th, 12th, 24th week after administration
Preliminary efficacy evaluation: cough score
Changes from baseline in value of cough score. To study the value of cough score(Cough Evaluation Test, CET) in evaluating the life quality of patients with ILD, and to recommend the appropriate dose of cell therapy for subsequent clinical studies.
Cough score(Cough Evaluation Test, CET)：Range 5-25, the higher the score, the more severe the daytime cough, the greater the impact of nighttime cough on sleep, and the greater the impact of cough on daily life and psychology.
Measured: The 4th, 12th, 24th week after administration
Preliminary efficacy evaluation: 6-minute walk test
Changes from baseline in result of 6-minute walk test (grade and distance) in the treatment of Interstitial lung disease(ILD), and to recommend the appropriate dose of cell therapy for subsequent clinical studies.
Draw a straight distance of 30.5 meters (100 feet) on a flat surface, and place a chair at each end as a marker. The subjects walked back and forth between them, with the pace determined by their own physical abilities. The personnel monitoring on the side report the time every 2 minutes and record any discomfort such as shortness of breath or chest pain that the subject may experience.
Measured: The 4th, 12th, 24th week after administration
Preliminary efficacy evaluation: Frequency of acute exacerbation events
Changes from baseline in Frequency of acute exacerbation events in the treatment of Interstitial lung disease(ILD), and to recommend the appropriate dose of cell therapy for subsequent clinical studies
Measured: The 4th, 12th, 24th week after administration
Preliminary efficacy evaluation: High Resolution Computed Tomography scores(HRCT score)
Changes from baseline in chest High Resolution Computed Tomography scores(Warrick score) in the treatment of Interstitial lung disease(ILD), and to recommend the appropriate dose of cell therapy for subsequent clinical studies.
HRCT score(Warrick score): Range 0-30,the higher the score, the more severe the lesion type and the wider the lesion range.
Measured: The 4th, 12th, 24th week after administration
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]：Blood pressure
Blood pressure in millimeter of mercury(mmHg)
Measured: The 4th, 12th, 24th week after administration
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]：Pulse
Pulse in beats per minute
Measured: The 4th, 12th, 24th week after administration
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]：respiration rate
Respiration rate in times/minute
Measured: The 4th, 12th, 24th week after administration
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]：body temperature
Body temperature in centigrade(℃)
Measured: The 4th, 12th, 24th week after administration
Blood routine
White blood cell count (WBC) in 10^9/L; Neutrophil count (Neu) in 10^9/L; Lymphocyte count (Lym) in 10^9/L; Monocyte count (Mon) in 10^9/L; Eosinophil count (Eos) in 10^9/L; Basophil count(Bas) in 10^9/L; Red blood cell count (RBC) in 10^9/L; Platelets(PLT) in 10^9/L; Hemoglobin (HGB) in g/L; Mean corpuscular hemoglobin concentration (MCHC) in g/L; Hematocrit (HCT) in percentage(%); Mean corpuscular volume (MCV) in femtoliter(fL).
Measured: The 4th, 12th, 24th week after administration
Blood biochemistry
Total protein (TP) in g/L; Albumin (ALB) in g/L; Total bilirubin (TBIL) in umol/L, Direct bilirubin (DBIL) in umol/L, Total bile acid (TBA) in umol/L, Creatinine (Cr) in umol/L, Uric acid (UriC) in umol/L; Alanine aminotransferase (ALT) in U/L Aspartate aminotransferase (AST) in U/L; Alkaline phosphatase (ALP) in U/L; Gamma glutamyl transpeptidase (GGT) in U/L; Lactate dehydrogenase (LDH) in U/L; Fasting blood glucose (Glu) in mmol/L; Potassium ions (K+) in mmol/L; Sodium ions (Na+) in mmol/L; Chloride ions (Cl -) in mmol/L; Calcium ions (Ca2+) in mmol/L; Glycated hemoglobin (HbA1c) in percentage(%);
Measured: The 4th, 12th, 24th week after administration
Blood gas analysis
PH; Arterial partial pressure of oxygen (PaO2) in mmHg Arterial partial pressure of carbon dioxide (PaCO2) in mmHg
Measured: The 4th, 12th, 24th week after administration
Concentration of Lung tumor markers
Cytokeratin 19 fragment (CYFRA21-1) in ng/mL; Neuron specific enolase (NSE) in ng/mL; Squamous cell carcinoma antigen (SCC) in ng/mL; Carcinoembryonic antigen (CEA) in ng/mL; Carbohydrate antigen(CA125) in Unit/mL.
Measured: The 4th, 12th, 24th week after administration
Electrocardiogram
Heart rate in beats/minute; PR interval in millisecond(ms) QRS interval in millisecond(ms) QT interval (uncorrected) in millisecond(ms)
Measured: The 4th, 12th, 24th week after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Dose1 Group：6.0×10\^6 cells/person, single-dose Dose2 Group：3.0×10\^7 cells/person, single-dose Dose3 Group：6.0×10\^7 cells/person, single-dose Dose4 Group：9.0×10\^7 cells/person, single-dose
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Life Science & Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534528
- Sponsor's protocol ID
- SHLF-MSC-ILD-101
- Status last verified
- May 2026
- First submitted
- 12 Jul 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maher TM. Interstitial Lung Disease: A Review. JAMA. 2024 May 21;331(19):1655-1665. doi: 10.1001/jama.2024.3669.
PubMed 38648021Rosas IO, Dellaripa PF, Lederer DJ, Khanna D, Young LR, Martinez FJ. Interstitial lung disease: NHLBI Workshop on the Primary Prevention of Chronic Lung Diseases. Ann Am Thorac Soc. 2014 Apr;11 Suppl 3(Suppl 3):S169-77. doi: 10.1513/AnnalsATS.201312-429LD.
PubMed 24754826Gille T, Laveneziana P. Cardiopulmonary exercise testing in interstitial lung diseases and the value of ventilatory efficiency. Eur Respir Rev. 2021 Nov 30;30(162):200355. doi: 10.1183/16000617.0355-2020. Print 2021 Dec 31.
PubMed 34853093Hass R, Kasper C, Bohm S, Jacobs R. Different populations and sources of human mesenchymal stem cells (MSC): A comparison of adult and neonatal tissue-derived MSC. Cell Commun Signal. 2011 May 14;9:12. doi: 10.1186/1478-811X-9-12.
PubMed 21569606Moodley Y, Atienza D, Manuelpillai U, Samuel CS, Tchongue J, Ilancheran S, Boyd R, Trounson A. Human umbilical cord mesenchymal stem cells reduce fibrosis of bleomycin-induced lung injury. Am J Pathol. 2009 Jul;175(1):303-13. doi: 10.2353/ajpath.2009.080629. Epub 2009 Jun 4.
PubMed 19497992Averyanov A, Koroleva I, Konoplyannikov M, Revkova V, Lesnyak V, Kalsin V, Danilevskaya O, Nikitin A, Sotnikova A, Kotova S, Baklaushev V. First-in-human high-cumulative-dose stem cell therapy in idiopathic pulmonary fibrosis with rapid lung function decline. Stem Cells Transl Med. 2020 Jan;9(1):6-16. doi: 10.1002/sctm.19-0037. Epub 2019 Oct 15.
PubMed 31613055Chambers DC, Enever D, Ilic N, Sparks L, Whitelaw K, Ayres J, Yerkovich ST, Khalil D, Atkinson KM, Hopkins PM. A phase 1b study of placenta-derived mesenchymal stromal cells in patients with idiopathic pulmonary fibrosis. Respirology. 2014 Oct;19(7):1013-8. doi: 10.1111/resp.12343. Epub 2014 Jul 9.
PubMed 25039426Glassberg MK, Minkiewicz J, Toonkel RL, Simonet ES, Rubio GA, DiFede D, Shafazand S, Khan A, Pujol MV, LaRussa VF, Lancaster LH, Rosen GD, Fishman J, Mageto YN, Mendizabal A, Hare JM. Allogeneic Human Mesenchymal Stem Cells in Patients With Idiopathic Pulmonary Fibrosis via Intravenous Delivery (AETHER): A Phase I Safety Clinical Trial. Chest. 2017 May;151(5):971-981. doi: 10.1016/j.chest.2016.10.061. Epub 2016 Nov 24.
PubMed 27890713
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Clinical Study Exploring the Safety, Tolerability, and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Interstitial Lung Disease (ILD)
- ClinicalTrials.gov ID
- NCT06534528
- Acronym / sponsor ID
- SHLF-MSC-ILD-101
- Conditions
- Interstitial Lung Disease
- Keywords
- Interstitial Lung Disease, ILD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shanghai Life Science & TechnologyIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 2 Aug 2024 (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.
Main objective: To explore the safety and tolerability of human umbilical cord mesenchymal stem cell injection in the treatment of interstitial lung disease (ILD); Secondary objective: To explore the preliminary effectiveness of human umbilical cord mesenchymal stem cell therapy for interstitial lung disease (ILD) and recommend appropriate cell therapy doses for subsequent clinical studies; Exploring the immunogenicity of human umbilical cord mesenchymal stem cell injection in the treatment of interstitial lung disease (ILD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose1 Group：6.0×10^6 cells/person, single-dose Dose2 Group：3.0×10^7 cells/person, single-dose Dose3 Group：6.0×10^7 cells/person, single-dose Dose4 Group：9.0×10^7 cells/person, single-dose
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: Human umbilical cord mesenchymal stem cell injectionFour different doses were set, and three subjects in each dose plan received human umbilical cord mesenchymal stem cell injection successively. Each subject received a single dose of 6.0*10^6, 3.0*10^7,6.0*10^7, and 9.0*10^7 cells / person. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Gender not limited, age ≥ 18 years old (including threshold);
- Clinical diagnosis of interstitial lung disease;
- Blood biochemistry tests must meet the following criteria: alanine aminotransferase (ALT) ≤ 2.5 × ULN, aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin (TBIL) ≤ 2 × ULN, direct bilirubin (DBIL) ≤ 1.5 × ULN, or creatinine (Cr) ≤ 3 × ULN;
- The diffusion capacity of carbon monoxide (DLCO) (corrected by Hb) in lung function tests within the previous 3 months is 30% to 80% of the expected value (including 30% and 80%); Forced vital capacity (FVC) is 40% to 70% of the estimated value (including 40% and 70%)
Key exclusion criteria (14 listed)
- Within the first 3 days of enrollment, use high-dose corticosteroids (equivalent to methylprednisolone>240 mg/day) or irregularly use systemic corticosteroids;
- For patients receiving immunosuppressive therapy, unstable background treatment with cyclophosphamide, mycophenolate mofetil/sodium, methotrexate, or other immunosuppressive monotherapy is not allowed (combination therapy is not allowed)
- Diagnose IPF patients who have previously taken drugs that may cause or worsen pulmonary fibrosis;
- Individuals with a history of mechanical ventilation or concurrent infectious pneumonia or asthma within the previous month prior to screening; Patients with airway obstruction disease (FEV1/FVC<0.7 before using bronchodilators); Patients with other clinically significant serious abnormalities in the lungs; Currently requiring oxygen therapy treatment (oxygen therapy time>15h/d);
- Pregnant and lactating women
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 |
|---|---|---|
| Human umbilical cord mesenchymal stem cell injectionDifferent doses of human umbilical cord mesenchymal stem cell injection were infused to the focus of patients with idiopathic pulmonary fibrosis through bronchoscope, and the tolerance of subjects to different doses of human umbilical cord mesenchymal stem cell injection was observed, and the curative effect was preliminarily observed. | Drug | Dose escalation |
Primary outcome
Maximum tolerated dose per dose (MTD)
Time frame: From the first administration to 4 weeks after administration
The maximum tolerable dose (MTD) of a single administration depends on whether dose limiting toxicity (DLT) occurs within 4 weeks after the first administration, for example (1) Hematological toxicity of grade 3 and above caused by the treatment of human umbilical cord mesenchymal stem cell injection. There are grade 3 and above non hematological toxic reactions caused by the treatment of human umbilical cord mesenchymal stem cell injection, except for the following cases, (3) Any other toxicity related to cell therapy that is higher than the baseline level is judged as clinically significant and / or unacceptable by the investigator and the sponsor, (4) There are acute exacerbations and serious adverse events (SAE) of IPF related to the treatment of human umbilical cord mesenchymal stem cell injection (which may be related, likely to be related and definitely related)
16 secondary outcomes
Preliminary efficacy evaluation：lung function
Time frame: The 4th, 12th, 24th week after administration
Preliminary efficacy evaluation: St. George's respiratory questionnaire(SGRQ)
Time frame: The 4th, 12th, 24th week after administration
Preliminary efficacy evaluation: dyspnea score
Time frame: The 4th, 12th, 24th week after administration
Preliminary efficacy evaluation: cough score
Time frame: The 4th, 12th, 24th week after administration
Preliminary efficacy evaluation: 6-minute walk test
Time frame: The 4th, 12th, 24th week after administration
Preliminary efficacy evaluation: Frequency of acute exacerbation events
Time frame: The 4th, 12th, 24th week after administration
Preliminary efficacy evaluation: High Resolution Computed Tomography scores(HRCT score)
Time frame: The 4th, 12th, 24th week after administration
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]：Blood pressure
Time frame: The 4th, 12th, 24th week after administration
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]：Pulse
Time frame: The 4th, 12th, 24th week after administration
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]：respiration rate
Time frame: The 4th, 12th, 24th week after administration
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]：body temperature
Time frame: The 4th, 12th, 24th week after administration
Blood routine
Time frame: The 4th, 12th, 24th week after administration
Blood biochemistry
Time frame: The 4th, 12th, 24th week after administration
Blood gas analysis
Time frame: The 4th, 12th, 24th week after administration
Concentration of Lung tumor markers
Time frame: The 4th, 12th, 24th week after administration
Electrocardiogram
Time frame: The 4th, 12th, 24th week after administration
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 11 May 2026.
- Background: PubMed 38648021Maher TM. Interstitial Lung Disease: A Review. JAMA. 2024 May 21;331(19):1655-1665. doi: 10.1001/jama.2024.3669.
- Background: PubMed 24754826Rosas IO, Dellaripa PF, Lederer DJ, Khanna D, Young LR, Martinez FJ. Interstitial lung disease: NHLBI Workshop on the Primary Prevention of Chronic Lung Diseases. Ann Am Thorac Soc. 2014 Apr;11 Suppl 3(Suppl 3):S169-77. doi: 10.1513/AnnalsATS.201312-429LD.
- Background: PubMed 34853093Gille T, Laveneziana P. Cardiopulmonary exercise testing in interstitial lung diseases and the value of ventilatory efficiency. Eur Respir Rev. 2021 Nov 30;30(162):200355. doi: 10.1183/16000617.0355-2020. Print 2021 Dec 31.
- Background: PubMed 21569606Hass R, Kasper C, Bohm S, Jacobs R. Different populations and sources of human mesenchymal stem cells (MSC): A comparison of adult and neonatal tissue-derived MSC. Cell Commun Signal. 2011 May 14;9:12. doi: 10.1186/1478-811X-9-12.
- Background: PubMed 19497992Moodley Y, Atienza D, Manuelpillai U, Samuel CS, Tchongue J, Ilancheran S, Boyd R, Trounson A. Human umbilical cord mesenchymal stem cells reduce fibrosis of bleomycin-induced lung injury. Am J Pathol. 2009 Jul;175(1):303-13. doi: 10.2353/ajpath.2009.080629. Epub 2009 Jun 4.
- Background: PubMed 31613055Averyanov A, Koroleva I, Konoplyannikov M, Revkova V, Lesnyak V, Kalsin V, Danilevskaya O, Nikitin A, Sotnikova A, Kotova S, Baklaushev V. First-in-human high-cumulative-dose stem cell therapy in idiopathic pulmonary fibrosis with rapid lung function decline. Stem Cells Transl Med. 2020 Jan;9(1):6-16. doi: 10.1002/sctm.19-0037. Epub 2019 Oct 15.
- Background: PubMed 25039426Chambers DC, Enever D, Ilic N, Sparks L, Whitelaw K, Ayres J, Yerkovich ST, Khalil D, Atkinson KM, Hopkins PM. A phase 1b study of placenta-derived mesenchymal stromal cells in patients with idiopathic pulmonary fibrosis. Respirology. 2014 Oct;19(7):1013-8. doi: 10.1111/resp.12343. Epub 2014 Jul 9.
- Background: PubMed 27890713Glassberg MK, Minkiewicz J, Toonkel RL, Simonet ES, Rubio GA, DiFede D, Shafazand S, Khan A, Pujol MV, LaRussa VF, Lancaster LH, Rosen GD, Fishman J, Mageto YN, Mendizabal A, Hare JM. Allogeneic Human Mesenchymal Stem Cells in Patients With Idiopathic Pulmonary Fibrosis via Intravenous Delivery (AETHER): A Phase I Safety Clinical Trial. Chest. 2017 May;151(5):971-981. doi: 10.1016/j.chest.2016.10.061. Epub 2016 Nov 24.
- 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 Phase 1 study testing Human umbilical cord mesenchymal stem cell injection in people with Interstitial Lung Disease, run by Shanghai Life Science & Technology.
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 4 inclusion and 14 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 11 May 2026. 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?
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.
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 Lu Gang, Vice President (086-13701662450, glu@shlifestemcell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose per dose (MTD) (time frame: From the first administration to 4 weeks after administration). 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 NCT06534528, which also lists 8 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 11 May 2026.