Idiopathic Pulmonary FibrosisPhase 1NCT05468502
Phase I/IIa Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)
A Phase 1 study testing Human umbilical cord mesenchymal stem cell injection in people with Idiopathic Pulmonary Fibrosis, run by Shanghai Life Science & Technology at 1 site in China.
Trial summary
Main purpose -To explore the safety and tolerance of human umbilical cord mesenchymal stem cells in the treatment of idiopathic pulmonary fibrosis (IPF). Secondary purpose To explore the preliminary efficacy of human umbilical cord mesenchymal stem cells in the treatment of idiopathic pulmonary fibrosis (IPF), and to… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- 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
- 17 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2022to 1 Aug 2025
- Phase
- Phase 1
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-75 years (inclusive), regardless of gender;
- Diagnosed with idiopathic pulmonary fibrosis (IPF) according to the 2018 diagnostic guidelines jointly issued by the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Association (ALAT);
- Subjects with typical HRCT imaging manifestations of IPF (honeycombing, traction bronchiectasis or bronchiolectasis (mainly appearing in ground-glass opacities and fine reticular opacities)) within 12 months prior to screening;
- Subjects whose disease is assessed by the investigator as stable within 3 months prior to dosing, with diffusing capacity for carbon monoxide (DLCO) at 30%-79% of the predicted value (adjusted for Hb), and FVC/predicted value ≥50%;
- Blood biochemical tests must meet the following criteria: alanine aminotransferase (ALT) ≤1.5×ULN, aspartate aminotransferase (AST) ≤1.5×ULN, total bilirubin (TBIL) ≤1.5×ULN, direct bilirubin (DBIL) ≤1.5×ULN, serum creatinine (Cr) ≤1.5×ULN;
- Expected survival ≥12 months;
- Subjects with good compliance, who are able to understand and cooperate in performing pulmonary function tests, and are willing to receive medication as required by the protocol and undergo follow-up examinations on schedule;
- Subjects who voluntarily participate in the trial, understand, and sign the informed consent form.
Who cannot join
- Subjects, who have previously received stem cell therapy, are intolerant to cell therapy, or have taken drugs that may cause or exacerbate pulmonary fibrosis (such as amiodarone, bleomycin, or methotrexate, etc.);
- Subjects with interstitial lung disease (ILD) other than IPF, including but not limited to: any other type of interstitial pneumonia; lung diseases associated with exposure to fibrogenic agents or other environmental toxins or drugs; other types of occupational lung diseases; granulomatous lung diseases; pulmonary vascular diseases; systemic diseases, including vasculitis, infectious diseases (i.e., tuberculosis), and connective tissue diseases;
- Subjects currently requiring oxygen therapy (oxygen therapy time ≥15 hours/day);
- Subjects with a history of mechanical ventilation or concurrent infectious pneumonia or asthma within 1 month prior to screening;
- Subjects with a history of malignancy within 5 years prior to screening;
- Subjects who have been hospitalized three or more times due to acute exacerbation of IPF or other respiratory diseases within 1 year prior to screening;
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- Evidence of current digestive, urinary, cardiovascular, cerebrovascular, hematological, neurological, psychiatric, or metabolic diseases that may affect safety, such as poorly controlled type 2 diabetes (fasting blood glucose ≥10.0 mmol/L or HbA1c ≥8.5%) or poorly controlled hypertension (≥160/100 mmHg).
- History of psychotropic drug abuse or drug addiction;
- Known history of immune system diseases (e.g., thymic diseases, systemic lupus erythematosus);
- Subjects with positive serological virology tests (HBsAg, HCV antibody, HIV antibody, Treponema pallidum antibody); however, hepatitis B virus carriers, stable hepatitis B patients after drug treatment (DNA titer ≤500 IU/mL or copy number <1000 copies/mL), and cured hepatitis C patients (HCV RNA negative) may be enrolled after being deemed eligible by the investigator;
- Subjects allergic to human albumin, anesthetic drugs, or any of their components;
- Subjects who have participated in any other clinical trial within 3 months prior to screening;
- Subjects who cannot tolerate bronchoscopy (including but not limited to the following conditions: active massive hemoptysis; severe hypertension and arrhythmia; myocardial infarction within 4-6 weeks prior to screening or history of unstable angina; severe cardiopulmonary dysfunction; uncorrectable bleeding tendency (platelet count <60×109/L), such as severe coagulation disorders, uremia, and severe pulmonary hypertension; severe superior vena cava obstruction syndrome; suspected aortic aneurysm; multiple pulmonary bullae; extreme systemic exhaustion);
- Subjects deemed by the investigator to be at high risk for general/local anesthesia;
- Pregnant or lactating women, or those with a positive β-human chorionic gonadotropin (β-HCG) test during screening, or those unable or unwilling to adopt effective non-pharmacological contraceptive measures during the study and for 6 months after study completion;
- Other circumstances deemed by the investigator as unsuitable for participation in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
About this study
Official title: An Open Clinical Study to Explore the Safety, Tolerance and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)
Main purpose
-To explore the safety and tolerance of human umbilical cord mesenchymal stem cells in the treatment of idiopathic pulmonary fibrosis (IPF).
Secondary purpose
- To explore the preliminary efficacy of human umbilical cord mesenchymal stem cells in the treatment of idiopathic pulmonary fibrosis (IPF), and to recommend the appropriate dose of cell therapy for subsequent clinical studies.
- To explore the immunogenicity of human umbilical cord mesenchymal stem cell injection in the treatment of idiopathic pulmonary fibrosis (IPF).
This study adopts a clinical research design of multi center, single dose and increasing dose.
18 qualified IPF subjects will be included in this study.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Human umbilical cord mesenchymal stem cell injection
- Keywords
- Idiopathic pulmonary fibrosis, IPF
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
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 1.2*10^8 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.
Tolerance of patients with idiopathic fibrosis to human umbilical cord mesenchymal stem cell injection
Incidence and severity of adverse events according to CTCAE5.0
Measured: From the first administration to 4 weeks after administration
Dose exploration of patients with idiopathic fibrosis to human umbilical cord mesenchymal stem cell injection
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,
（2） 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 (2)
Preliminary efficacy evaluation
Changes from baseline in St. George's respiratory questionnaire SGRQ, dyspnea score, cough score and 6-minute walk test (grade and distance)in the treatment of idiopathic pulmonary fibrosis (IPF), and to recommend the appropriate dose of cell therapy for subsequent clinical studies
Measured: The 4th, 12th, 24th and 48th week after administration
Preliminary efficacy evaluation
Changes in lung function (FVC, DLCO sb) compared with baseline
Measured: The 4th, 12th, 24th and 48th 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 posted21 Jul 2022
- Study start10 Oct 2022
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
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
- NCT05468502
- Sponsor's protocol ID
- SHLF-MSC-101
- Status last verified
- Dec 2025
- First submitted
- 12 Jul 2022
- Last updated
- 26 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
Glassberg 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 27890713Tzouvelekis A, Paspaliaris V, Koliakos G, Ntolios P, Bouros E, Oikonomou A, Zissimopoulos A, Boussios N, Dardzinski B, Gritzalis D, Antoniadis A, Froudarakis M, Kolios G, Bouros D. A prospective, non-randomized, no placebo-controlled, phase Ib clinical trial to study the safety of the adipose derived stromal cells-stromal vascular fraction in idiopathic pulmonary fibrosis. J Transl Med. 2013 Jul 15;11:171. doi: 10.1186/1479-5876-11-171.
PubMed 23855653Chambers 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 25039426Moodley 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 19497992Hass 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 21569606Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.
PubMed 21471066
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Clinical Study to Explore the Safety, Tolerance and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)
- ClinicalTrials.gov ID
- NCT05468502
- Acronym / sponsor ID
- SHLF-MSC-101
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Idiopathic pulmonary fibrosis, IPF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Shanghai Life Science & TechnologyIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 21 Jul 2022 (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 purpose
-To explore the safety and tolerance of human umbilical cord mesenchymal stem cells in the treatment of idiopathic pulmonary fibrosis (IPF).
Secondary purpose
- To explore the preliminary efficacy of human umbilical cord mesenchymal stem cells in the treatment of idiopathic pulmonary fibrosis (IPF), and to recommend the appropriate dose of cell therapy for subsequent clinical studies.
- To explore the immunogenicity of human umbilical cord mesenchymal stem cell injection in the treatment of idiopathic pulmonary fibrosis (IPF).
This study adopts a clinical research design of multi center, single dose and increasing dose.
18 qualified IPF subjects will be included in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| 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 1.2*10^8 cells / person. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 40-75 years (inclusive), regardless of gender;
- Diagnosed with idiopathic pulmonary fibrosis (IPF) according to the 2018 diagnostic guidelines jointly issued by the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Association (ALAT);
- Subjects with typical HRCT imaging manifestations of IPF (honeycombing, traction bronchiectasis or bronchiolectasis (mainly appearing in ground-glass opacities and fine reticular opacities)) within 12 months prior to screening;
- Subjects whose disease is assessed by the investigator as stable within 3 months prior to dosing, with diffusing capacity for carbon monoxide (DLCO) at 30%-79% of the predicted value (adjusted for Hb), and FVC/predicted value ≥50%;
- Blood biochemical tests must meet the following criteria: alanine aminotransferase (ALT) ≤1.5×ULN, aspartate aminotransferase (AST) ≤1.5×ULN, total bilirubin (TBIL) ≤1.5×ULN, direct bilirubin (DBIL) ≤1.5×ULN, serum creatinine (Cr) ≤1.5×ULN;
Key exclusion criteria (16 listed)
- Subjects, who have previously received stem cell therapy, are intolerant to cell therapy, or have taken drugs that may cause or exacerbate pulmonary fibrosis (such as amiodarone, bleomycin, or methotrexate, etc.);
- Subjects with interstitial lung disease (ILD) other than IPF, including but not limited to: any other type of interstitial pneumonia; lung diseases associated with exposure to fibrogenic agents or other environmental toxins or drugs; other types of occupational lung diseases; granulomatous lung diseases; pulmonary vascular diseases; systemic diseases, including vasculitis, infectious diseases (i.e., tuberculosis), and connective tissue diseases;
- Subjects currently requiring oxygen therapy (oxygen therapy time ≥15 hours/day);
- Subjects with a history of mechanical ventilation or concurrent infectious pneumonia or asthma within 1 month prior to screening;
- Subjects with a history of malignancy within 5 years prior to screening;
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
Tolerance of patients with idiopathic fibrosis to human umbilical cord mesenchymal stem cell injection
Time frame: From the first administration to 4 weeks after administration
Incidence and severity of adverse events according to CTCAE5.0
Dose exploration of patients with idiopathic fibrosis to human umbilical cord mesenchymal stem cell injection
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, （2） 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)
2 secondary outcomes
Preliminary efficacy evaluation
Time frame: The 4th, 12th, 24th and 48th week after administration
Preliminary efficacy evaluation
Time frame: The 4th, 12th, 24th and 48th week after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- 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.
- Background: PubMed 23855653Tzouvelekis A, Paspaliaris V, Koliakos G, Ntolios P, Bouros E, Oikonomou A, Zissimopoulos A, Boussios N, Dardzinski B, Gritzalis D, Antoniadis A, Froudarakis M, Kolios G, Bouros D. A prospective, non-randomized, no placebo-controlled, phase Ib clinical trial to study the safety of the adipose derived stromal cells-stromal vascular fraction in idiopathic pulmonary fibrosis. J Transl Med. 2013 Jul 15;11:171. doi: 10.1186/1479-5876-11-171.
- 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 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 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 21471066Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.
- Individual participant dataSharing planned: Undecided. Undecided: It is not yet known if there will be a plan to make IPD available.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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 Idiopathic Pulmonary Fibrosis, run by Shanghai Life Science & Technology 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 8 inclusion and 16 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: finished, as of the sponsor's last update on 26 Dec 2025. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance of patients with idiopathic fibrosis to human umbilical cord mesenchymal stem cell injection (time frame: From the first administration to 4 weeks after administration). The study lists 2 primary outcomes in all. 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 NCT05468502, which also lists 6 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 26 Dec 2025.