Idiopathic Pulmonary Fibrosis (IPF)Phase 2IPF IINCT07131150
Menstrual Blood-Derived Mesenchymal Stem Cell Injection (SC01009) in the Treatment of Idiopathic Pulmonary Fibrosis
A Phase 2 study testing SC01009 injection in people with Idiopathic Pulmonary Fibrosis (IPF), run by Ruijin Hospital at 22 sites in China.
Trial summary
At present, the diagnosis of IPF is still difficult and it cannot be completely cured. Treatment is still aimed at improving symptoms and delaying the decline of lung function. The treatment measures for IPF mainly include drug therapy ( pirfenidone and nintedanib), non-drug therapy (such as oxygen therapy, pulmonary… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- SC01009 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 22 sitesChina
- Study dates
- 31 Aug 2025to 31 Jul 2028
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Voluntarily sign the written informed consent (ICF) and agree to complete the trial according to the protocol requirements;
- 2. ≥ 18 and ≤ 80 years old when signing the ICF , regardless of gender;
- 3. Diagnostic Confirmation of IPF;
- 4. ≥ 50% and ≤ 90% at screening ; DLCO% ≥ 30% and ≤ 90% (corrected for hemoglobin [Hb]);
- 5. received nintedanib or pirfenidone treatment for at least 8 weeks before screening and do not plan to start or restart anti-fibrotic treatment; or patients who have received stable nintedanib or pirfenidone treatment for at least 8 weeks before screening and do not receive combination therapy of nintedanib and pirfenidone ;
- 6. 2 ≥ 60 mmHg at screening ; able to complete the 6- minute walk test ( 6MWT ) and walk distance > 150 m;
- 7. are willing to use at least one effective contraceptive method for contraception during the study .
Who cannot join
- 1. Other lung diseases within 6 months before screening, including chronic obstructive pulmonary disease (forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) after using bronchodilator < 0.70), emphysema (emphysema occupies ≥ 50% of the entire HRCT according to the central review of HRCT, or the degree of emphysema is greater than the degree of fibrosis), pulmonary hypertension ≥ 50 mmHg indicated by echocardiography , active tuberculosis, pulmonary embolism, uncontrolled asthma, pneumothorax, pneumoconiosis, bronchiolitis obliterans or other active lung diseases;
- 2. In addition to IPF, there are other types of interstitial lung disease (ILD), including ILD with known causes (such as family or occupational environmental exposure, connective tissue disease and drug toxicity, etc.), granulomatous ILD (such as sarcoidosis), and other rare ILD (such as alveolar proteinosis, pulmonary amyloidosis, etc.); among them, for the exclusion of connective tissue disease-related interstitial lung disease ( CTD-ILD), relevant examinations within 12 months before screening were accepted;
- 3. Patients who are in the acute exacerbation stage of IPF at the time of screening, or who have AE-IPF within 3 months before screening (determined by the investigator); AE-IPF is defined as: IPF patients who have a significant acute deterioration of respiratory function in a short period of time, mainly characterized by the new appearance of diffuse ground-glass shadows and/or consolidation shadows in both lungs on the original UIP background on chest HRCT;
- 4. Patients with lung infection or other serious infection requiring intravenous antibiotic treatment within 4 weeks before screening;
- 5. Patients with a history or evidence of major cardiovascular disease within 6 months before screening, including but not limited to: myocardial infarction, coronary angioplasty or bypass surgery, heart valve repair, II or III degree atrioventricular block, malignant arrhythmia ( such as ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, atrial flutter, etc. ), unstable angina, transient ischemic attack, cerebrovascular accident, congestive heart failure with a heart function grade of III or IV of the New York Heart Association (NYHA) , etc.; or left ventricular ejection fraction (LVEF) <50% at screening;
- 6. Patients with a history of tumor (except for patients with cured basal cell carcinoma of the skin, squamous cell carcinoma in situ of the skin, or carcinoma in situ of the cervix), or patients whose tumor marker examinations are determined by the investigator to be clinically significant and may affect safety assessments;
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- 7. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × upper limit of normal (ULN), or total bilirubin (TBIL) >1.5 × ULN at screening;
- 8. Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m² at screening;
- 9. Patients who are positive for hepatitis B surface antigen (HBsAg) and hepatitis B virus deoxyribonucleic acid (HBV-DNA) ≥ the lower limit of the detection value during screening, or who are positive for hepatitis C virus (HCV) antibody and hepatitis C virus ribonucleic acid (HCV-RNA) ≥ the lower limit of the detection value, or who are positive for human immunodeficiency virus (HIV) antibody, or who are positive for Treponema pallidum antibody (Those who are positive for Treponema pallidum antibody need to undergo non-specific syphilis antibody test and the researchers will determine whether they can participate in the trial);
- 10. Blood pressure is still not controlled after antihypertensive drug treatment within 3 months before screening, and blood pressure during the screening period is ≥ 160/100 mmHg;
- 11. Patients planning to receive lung transplantation or with a history of solid organ transplantation;
- 12. Those who have undergone lung resection; or those who have undergone major surgery (including lung surgery) or unhealed wounds (except for diagnostic surgery or when the investigator determines that the subject has fully recovered from the surgery) within 4 weeks before screening, or those who are planning to undergo major surgery;
- 13. 20 mg/ d (or other glucocorticoids of equivalent dose) within 28 days before screening ;
- 14. Use of cytotoxic drugs (such as chloramphenicol, azathioprine , cyclophosphamide, methotrexate ) or pulmonary hypertension drugs (such as endothelin receptor antagonists [such as bosentan, ambrisentan, macitentan], PDE5 inhibitors [such as sildenafil, tadalafil, vardenafil ]) within 4 weeks or 5 half -lives before screening (whichever is longer) ;
- 15. Use of drugs that may cause pulmonary fibrosis within 6 months before screening, such as amiodarone, bleomycin, etc.;
- 16. Patients who are known or suspected to be allergic to the active or inactive ingredients of the investigational drug (such as dimethyl sulfoxide [DMSO], human serum albumin [HSA], dextran, and compound electrolytes) ;
- 17. Those with a history of drug abuse or other serious mental illness, who may increase the risk of participating in the study or interfere with the study treatment and research results as determined by the researchers;
- 18. Participants who have participated in any other clinical trials within 3 months before screening (except patients who have not received trial drugs); or participated in mesenchymal stem cell clinical trials within 2 years before screening; or received other types of stem cells before screening;
- 19. Other situations that the researcher considers unsuitable for participation in this trial.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
China22 sites
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100005
Feng kai xu, Professor, 13701062854, xukf@pumch.cn
feng kai xu, Professor
Beijing Chaoyang Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100013
qiao ye, Professor, 13436520511, yeqiao_chaoyang@sina.com
qiao ye, Professor
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
ping hua DAI, Professor, 13901293597, chen.yang7@tigermedgrp.com
ping hua Dai, Professor
Beijing FriendBeijing Friendship Hospital, Capital Medical UniversityBeijing Friendship Hospital, Capital Medical Universityship Hospital, Capital Medical University
Beijing, Beijing Municipality
ting chun Tan, Professor, 13811516879, chuntingtan@126.com
ting chun Tan, Professor
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality
xin yuan, Professor, 15601089873, xinyuannatile@sina.com
xin yuan, Professor
The Second Hospital of Jilin University
Changchun, Jielin
jie Zhang, Professor, 13504326312, doctorzhangj@163.com
jie Zhang, Professor
The Second Xiangya Hospital of Central South University The Third Xiangya Hospital of Central South University
Changsha, Hunan
jie meng, Professor, 13607492399, mjie0101@163.com
jie meng, Professor
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
an zong Liang, Professor, 18980601259, liang.zongan@163.com
an zong Liang, Professor
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
lu guo, Professor, 18981838226, guolu189@163.com
lu Guo, Professor
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
qun Luo, Professor, 13710658121, luoqunx@163.com
qun Luo, Professor
The Second Hospital of Hebei Medical University
Hebei, Hebei, 230601
dong ya yuan, Professor, 15803210960, hebeiyyd@126.com
dong ya yuan, Professor
Drum Tower Hospital Affiliated to Nanjing University Medical School
Nanjing, Jiangsu, 210000
shu meng Cao, Professor, 13770838003, mengshucao@126.com
shu meng Cao, Professor
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200001
hui qin, Professor, 15000663758, drqinhui@126.com
dong han jiang, Professor
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Feng Li, Professor, 18017321517, lifeng741@aliyun.com
feng li, Professor
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
wu jiu bai, Professor
WU JIU BAI, Professor
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
yun ying Fu, Professor, 13602582239, yingyunf2013@163.com
yun ying FU, Professor
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
jie Cao, Professor, 13132088076, tjcaojie@sina.com
jie Cao, Professor
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
Air Force Medical University Xijing Hospital
Xi’an, Shanxi, 710000
feng Zhao, Professor, 13991186167, 1821621087@qq.com
feng Zhao, Professor
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221004
bi XU, Professor, 15005207551, chenbi207@126.com
bi Xu, Professor
Ningxia Medical University General Hospital
Yinchuan, Ningxia, 750004
juan 750004 Chen, 13014292231, chenjuan7419@163.com
juan Chen, Professor
Henan Provincial People's Hospital
Zhengzhou, Henan
ju xiao zhang, Professor, 15837101166, clinical202404@163.com
ju xiao Zhang, Professor
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cell Injection (SC01009) in the Treatment of Idiopathic Pulmonary Fibrosis
At present, the diagnosis of IPF is still difficult and it cannot be completely cured. Treatment is still aimed at improving symptoms and delaying the decline of lung function. The treatment measures for IPF mainly include drug therapy ( pirfenidone and nintedanib), non-drug therapy (such as oxygen therapy, pulmonary rehabilitation), treatment of complications/comorbidities, symptomatic treatment and palliative treatment. However, IPF cannot be completely cured at present, so lung transplantation is a feasible option for the treatment of IPF. However, due to the scarcity of donor lungs, prevention of acute and chronic rejection reactions, post-transplant infection complications, and high costs, its clinical implementation is limited. Therefore, there is still a large unmet treatment need for IPF, and new therapeutic drugs are urgently needed.
In recent years, mesenchymal stem cells (MSCs) have been considered a new hope for the treatment of IPF. MSCs are a type of multipotent stem cells with the potential for self-proliferation and differentiation. They have the characteristics of self-renewal, multidirectional differentiation, low immunogenicity, and paracrine. They can automatically home to damaged areas, promote epithelial tissue repair, inhibit inflammation, and inhibit abnormal proliferation of fibroblasts . Many clinical trials at home and abroad are exploring the effectiveness and safety of MSC in the treatment of pulmonary fibrosis. An Australian study found that in patients with moderate to severe IPF, intravenous infusion of umbilical cord MSCs up to 2 × 106 cells/kg was safe, and no decrease in forced vital capacity (FVC), diffusing vital capacity for carbon monoxide (DLCO), 6-minute walk test distance (6MWD), and CT fibrosis score was observed during a 6-month follow-up . The results of the American AETHER study also showed that a single intravenous infusion of up to 2 × 10^ 8 cells of bone marrow MSCs was safe, with no serious treatment-related adverse events observed. Moreover, 60 weeks after infusion , FVC% decreased by 3.0% and DLCO% decreased by 5.4%, both of which were below the threshold for disease progression .
Read more
This study adopted a multicenter, randomized, double-blind, placebo-controlled, parallel design to evaluate the efficacy and safety of SC01009 injection in IPF subjects .
This study plans to enroll 66 subjects, who will be randomly stratified according to whether they have received oral pirfenidone/nintedanib treatment at screening , and randomly assigned to two trial groups and one placebo group in a 1:1:1 ratio.
This study includes a screening period of up to 4 weeks, a 24-week treatment follow-up period, and a 2-year long-term follow-up period. After screening, qualified subjects will be given medication according to the following dosing schedule according to their group:
Trial Group 1: received intravenous infusion of SC01009 injection in week 1, divided into 3 infusions every other day, each infusion of 3 × 10^ 7 cells, with a total dose of 9 × 10 ^7 cells; received intravenous infusion of placebo in week 13, with the same administration method as in week 1; Experimental group 2: received intravenous infusion of SC01009 injection at week 1 and week 13, respectively. Each administration was divided into 3 infusions every other day, with 3 × 10^7 cells in each infusion , and the total dose was 1.8 × 10^8 cells.
Placebo group: received intravenous infusion of placebo at week 1 and week 13, respectively, with the same administration method as the cell therapy group.
After completing 24 weeks of treatment follow-up, all subjects entered the long-term follow-up phase and were unblinded after the study database was locked . The subjects in the original placebo group could end the follow-up, while the subjects receiving cell therapy would continue to be followed up for up to 2 years.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- SC01009 injection, Placebo Group(Vehicle)
- 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.
SC01009 injectionBiological
Menstrual Blood-Derived Mesenchymal Stem Cell (Product Code: SC01009) Injection is a cell therapy product developed by Zhejiang Sinocord Precision Medicine Technology Co., Ltd. The active component consists of mesenchymal stem cells (MSCs) derived from menstrual blood.
Placebo Group(Vehicle)Biological
The placebo consists of the SC01009 Injection formulation solution, containing all components identical to the active product except for the absence of mesenchymal stem cells.
| Study group | Role | What they receive |
|---|---|---|
| Trial Group 1 | Experimental | Not described Receives: Biological: SC01009 injection |
| Trial Group2 | Experimental | Not described Receives: Biological: SC01009 injection |
| Placebo Group | Placebo comparator | Not described Receives: Biological: Placebo Group(Vehicle) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in forced vital capacity (FVC) (ml)
Measured: Baseline, Week 24
Secondary outcomes (14)
Changes from baseline in the diffusing capacity for carbon monoxide as a percentage of predicted value (DLCO%)
Measured: baseline, week 24
a. FVC (ml) decreased by ≥ 10% or DLCO% decreased by ≥ 15% compared with baseline; b. Acute exacerbation of IPF (AE-IPF); c. All-cause mortality occurred;
Measured: Time to first clinical worsening event, including any of the following
Changes in FVC (ml) from baseline
Measured: weeks 4 and 12
Changes from baseline in forced vital capacity % predicted (FVC%)
Measured: weeks 4, 12, and 24 ;
Changes in DLCO% from baseline
Measured: weeks 4 and 12
arterial oxygen partial pressure (PaO 2 ) from baseline
Measured: weeks 4 , 12 , and 24
Changes from baseline in 6-minute walk test distance (6MWD)
Measured: weeks 4, 12, and 24;
Changes from baseline in the Instructions for Completing the Living with Pulmonary Fibrosis Impacts Questionnaire (L-PF Impacts) and Instructions for Completing the Living with Pulmonary Fibrosis Symptoms Questionnaire (L-PF Symptoms)
Score range: 0 to 92, higher scores mean a worse outcome
Measured: weeks 4, 12, and 24
The occurrence of adverse events (AEs)/serious adverse events (SAEs)
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0，Tumorigenicity assessment during the 2-year observation period following the main observation period
Measured: Baseline，Day 1 ，up to 24 weeks，2years
Number of Participants with Post-Treatment Abnormalities in Laboratory tests
Number of Participants with Post-Treatment Abnormalities in Laboratory tests (Complete Blood Count, Blood Biochemistry, Urinalysis, Coagulation Function, C-reactive Protein [CRP]) as Assessed by CTCAE v5.0
Measured: Baseline，Day 1， up to 24 weeks
Number of Participants with Post-Treatment Abnormalities in Vital Signs
Number of Participants with Post-Treatment Abnormalities in Vital Signs as Assessed by CTCAE v5.0
Measured: Baseline，Day 1 ，up to 24 weeks
Number of Participants with post-treatment normality/abnormality transitions
Number of Participants with post-treatment normality/abnormality transitions (Normal, Abnormal - Not Clinically Significant, Abnormal - Clinically Significant)
Measured: Baseline，Day 1 ，up to 24 weeks
12- lead electrocardiogram ( ECG ) examination
including heart rate (HR), PR interval , QT interval, RR interval, QTcF and QRS complex duration，Clinical assessment outcomes (Normal, Abnormal - Not Clinically Significant, Abnormal - Clinically Significant) with pre-/post-treatment normality/abnormality transitions
Measured: Baseline，Day 1， up to 24 weeks
Occurrence of Infusion Reactions
Measured: during administration and within 8 hours after completion of administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start31 Aug 2025 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jieming QU, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131150
- Sponsor's protocol ID
- IPM01-XY1010-2
- Acronym
- IPF II
- Status last verified
- Aug 2025
- First submitted
- 14 Jul 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cell Injection (SC01009) in the Treatment of Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT07131150
- Acronym / sponsor ID
- IPF II / IPM01-XY1010-2
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 31 Aug 2025 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 20 Aug 2025 (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.
At present, the diagnosis of IPF is still difficult and it cannot be completely cured. Treatment is still aimed at improving symptoms and delaying the decline of lung function. The treatment measures for IPF mainly include drug therapy ( pirfenidone and nintedanib), non-drug therapy (such as oxygen therapy, pulmonary rehabilitation), treatment of complications/comorbidities, symptomatic treatment and palliative treatment. However, IPF cannot be completely cured at present, so lung transplantation is a feasible option for the treatment of IPF. However, due to the scarcity of donor lungs, prevention of acute and chronic rejection reactions, post-transplant infection complications, and high costs, its clinical implementation is limited. Therefore, there is still a large unmet treatment need for IPF, and new therapeutic drugs are urgently needed.
In recent years, mesenchymal stem cells (MSCs) have been considered a new hope for the treatment of IPF. MSCs are a type of multipotent stem cells with the potential for self-proliferation and differentiation. They have the characteristics of self-renewal, multidirectional differentiation, low immunogenicity, and paracrine. They can automatically home to damaged areas, promote epithelial tissue repair, inhibit inflammation, and inhibit abnormal proliferation of fibroblasts . Many clinical trials at home and abroad are exploring the effectiveness and safety of MSC in the treatment of pulmonary fibrosis. An Australian study found that in patients with moderate to severe IPF, intravenous infusion of umbilical cord MSCs up to 2 × 106 cells/kg was safe, and no decrease in forced vital capacity (FVC), diffusing vital capacity for carbon monoxide (DLCO), 6-minute walk test distance (6MWD), and CT fibrosis score was observed during a 6-month follow-up . The results of the American AETHER study also showed that a single intravenous infusion of up to 2 × 10^ 8 cells of bone marrow MSCs was safe, with no serious treatment-related adverse events observed. Moreover, 60 weeks after infusion , FVC% decreased by 3.0% and DLCO% decreased by 5.4%, both of which were below the threshold for disease progression .
This study adopted a multicenter, randomized, double-blind, placebo-controlled, parallel design to evaluate the efficacy and safety of SC01009 injection in IPF subjects .
This study plans to enroll 66 subjects, who will be randomly stratified according to whether they have received oral pirfenidone/nintedanib treatment at screening , and randomly assigned to two trial groups and one placebo group in a 1:1:1 ratio.
This study includes a screening period of up to 4 weeks, a 24-week treatment follow-up period, and a 2-year long-term follow-up period. After screening, qualified subjects will be given medication according to the following dosing schedule according to their group:
Trial Group 1: received intravenous infusion of SC01009 injection in week 1, divided into 3 infusions every other day, each infusion of 3 × 10^ 7 cells, with a total dose of 9 × 10 ^7 cells; received intravenous infusion of placebo in week 13, with the same administration method as in week 1; Experimental group 2: received intravenous infusion of SC01009 injection at week 1 and week 13, respectively. Each administration was divided into 3 infusions every other day, with 3 × 10^7 cells in each infusion , and the total dose was 1.8 × 10^8 cells.
Placebo group: received intravenous infusion of placebo at week 1 and week 13, respectively, with the same administration method as the cell therapy group.
After completing 24 weeks of treatment follow-up, all subjects entered the long-term follow-up phase and were unblinded after the study database was locked . The subjects in the original placebo group could end the follow-up, while the subjects receiving cell therapy would continue to be followed up for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trial Group 1 | Experimental | Biological: SC01009 injection |
| Trial Group2 | Experimental | Biological: SC01009 injection |
| Placebo Group | Placebo comparator | Biological: Placebo Group(Vehicle) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Voluntarily sign the written informed consent (ICF) and agree to complete the trial according to the protocol requirements;
- 2. ≥ 18 and ≤ 80 years old when signing the ICF , regardless of gender;
- 3. Diagnostic Confirmation of IPF;
- 4. ≥ 50% and ≤ 90% at screening ; DLCO% ≥ 30% and ≤ 90% (corrected for hemoglobin [Hb]);
- 5. received nintedanib or pirfenidone treatment for at least 8 weeks before screening and do not plan to start or restart anti-fibrotic treatment; or patients who have received stable nintedanib or pirfenidone treatment for at least 8 weeks before screening and do not receive combination therapy of nintedanib and pirfenidone ;
Key exclusion criteria (19 listed)
- 1. Other lung diseases within 6 months before screening, including chronic obstructive pulmonary disease (forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) after using bronchodilator < 0.70), emphysema (emphysema occupies ≥ 50% of the entire HRCT according to the central review of HRCT, or the degree of emphysema is greater than the degree of fibrosis), pulmonary hypertension ≥ 50 mmHg indicated by echocardiography , active tuberculosis, pulmonary embolism, uncontrolled asthma, pneumothorax, pneumoconiosis, bronchiolitis obliterans or other active lung diseases;
- 2. In addition to IPF, there are other types of interstitial lung disease (ILD), including ILD with known causes (such as family or occupational environmental exposure, connective tissue disease and drug toxicity, etc.), granulomatous ILD (such as sarcoidosis), and other rare ILD (such as alveolar proteinosis, pulmonary amyloidosis, etc.); among them, for the exclusion of connective tissue disease-related interstitial lung disease ( CTD-ILD), relevant examinations within 12 months before screening were accepted;
- 3. Patients who are in the acute exacerbation stage of IPF at the time of screening, or who have AE-IPF within 3 months before screening (determined by the investigator); AE-IPF is defined as: IPF patients who have a significant acute deterioration of respiratory function in a short period of time, mainly characterized by the new appearance of diffuse ground-glass shadows and/or consolidation shadows in both lungs on the original UIP background on chest HRCT;
- 4. Patients with lung infection or other serious infection requiring intravenous antibiotic treatment within 4 weeks before screening;
- 5. Patients with a history or evidence of major cardiovascular disease within 6 months before screening, including but not limited to: myocardial infarction, coronary angioplasty or bypass surgery, heart valve repair, II or III degree atrioventricular block, malignant arrhythmia ( such as ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, atrial flutter, etc. ), unstable angina, transient ischemic attack, cerebrovascular accident, congestive heart failure with a heart function grade of III or IV of the New York Heart Association (NYHA) , etc.; or left ventricular ejection fraction (LVEF) <50% at 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 |
|---|---|---|
| SC01009 injectionMenstrual Blood-Derived Mesenchymal Stem Cell (Product Code: SC01009) Injection is a cell therapy product developed by Zhejiang Sinocord Precision Medicine Technology Co., Ltd. The active component consists of mesenchymal stem cells (MSCs) derived from menstrual blood. | Biological | Trial Group 1, Trial Group2 |
| Placebo Group(Vehicle)The placebo consists of the SC01009 Injection formulation solution, containing all components identical to the active product except for the absence of mesenchymal stem cells. | Biological | Placebo Group |
Primary outcome
Change from baseline in forced vital capacity (FVC) (ml)
Time frame: Baseline, Week 24
14 secondary outcomes
Changes from baseline in the diffusing capacity for carbon monoxide as a percentage of predicted value (DLCO%)
Time frame: baseline, week 24
a. FVC (ml) decreased by ≥ 10% or DLCO% decreased by ≥ 15% compared with baseline; b. Acute exacerbation of IPF (AE-IPF); c. All-cause mortality occurred;
Time frame: Time to first clinical worsening event, including any of the following
Changes in FVC (ml) from baseline
Time frame: weeks 4 and 12
Changes from baseline in forced vital capacity % predicted (FVC%)
Time frame: weeks 4, 12, and 24 ;
Changes in DLCO% from baseline
Time frame: weeks 4 and 12
arterial oxygen partial pressure (PaO 2 ) from baseline
Time frame: weeks 4 , 12 , and 24
Changes from baseline in 6-minute walk test distance (6MWD)
Time frame: weeks 4, 12, and 24;
Changes from baseline in the Instructions for Completing the Living with Pulmonary Fibrosis Impacts Questionnaire (L-PF Impacts) and Instructions for Completing the Living with Pulmonary Fibrosis Symptoms Questionnaire (L-PF Symptoms)
Time frame: weeks 4, 12, and 24
The occurrence of adverse events (AEs)/serious adverse events (SAEs)
Time frame: Baseline，Day 1 ，up to 24 weeks，2years
Number of Participants with Post-Treatment Abnormalities in Laboratory tests
Time frame: Baseline，Day 1， up to 24 weeks
Number of Participants with Post-Treatment Abnormalities in Vital Signs
Time frame: Baseline，Day 1 ，up to 24 weeks
Number of Participants with post-treatment normality/abnormality transitions
Time frame: Baseline，Day 1 ，up to 24 weeks
12- lead electrocardiogram ( ECG ) examination
Time frame: Baseline，Day 1， up to 24 weeks
Occurrence of Infusion Reactions
Time frame: during administration and within 8 hours after completion of 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 20 Aug 2025.
- 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.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SC01009 injection in people with Idiopathic Pulmonary Fibrosis (IPF), run by Ruijin Hospital at 22 sites 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 19 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 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites 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. Some participants in this study may receive a placebo. 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 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?
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 Jieming Qu (86-18901661180, jmqu0906@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in forced vital capacity (FVC) (ml) (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2025.