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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

Safety, Tolerability and Efficacy of VUM02 Injection in Treatment of Idiopathic Pulmonary Fibrosis (IPF)

A Phase I Open Label, Dose Escalation Study to Characterize the Safety, Tolerability, and Efficacy of VUM02 Injection in Subjects With Idiopathic Pulmonary Fibrosis

Safety, Tolerability and Efficacy of VUM02 Injection in Treatment of Idiopathic Pulmonary Fibrosis (IPF) (NCT06230822) is a Phase 1 interventional studying Idiopathic Pulmonary Fibrosis, sponsored by Wuhan Optics Valley Vcanbiopharma Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study is a single-arm, multiple-dose, dose-escalation, open-label multicenter clinical trial, aiming to evaluate the safety, tolerability, and preliminary efficacy of VUM02 Injection for treatment of idiopathic pulmonary fibrosis (IPF). VUM02 Injection (Human Umbilical Cord Tissue-derived Mesenchymal Stem Cells Injection, hUCT-MSC) is an allogeneic cell therapy product comprising culture-expanded Mesenchymal Stem Cells derived from the human umbilical cord tissue. The product is cryopreserved with the amount of 5 x 10\^7 cells per 10 mL per bag (5 x 10\^6 cells/mL). This study is a multiple-dose tolerability study following the "3+3" dose escalation principle and progressing from the low-dose group to the high-dose group sequentially. Three to six patients will be enrolled in each dose group and administered every 3 days for a total of 3 doses.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Idiopathic Pulmonary Fibrosis, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 9 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: Patients must meet all of the following criteria to be eligible for this trial: 1. Gender unrestricted, aged between 40 and 75 years old (inclusive); 2. Diagnosed with IPF according to the 2022 Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline. 3. In the 3 months prior to administration, determined by the investigator to have stable disease, with diffusing capacity of the lung for carbon monoxide (DLCO) between 30% and 79% of the predicted value (adjusted for Hb), FVC/predicted ≥50%, and forced expiratory volume in one second (FEV1)/FVC ≥0.70; 4. Allowed to enroll are the patients who have been treated according to the current standard treatment plan for IPF and have maintained the treatment for at least 3 months; 5. Good compliance, able to understand and cooperate with pulmonary function test procedures, willing to participate voluntarily in the trial according to the protocol requirements, and understand and sign the willing to sign a consent form form voluntarily. Who Should NOT Join This Trial: Patients meeting any of the following criteria are not eligible for this trial: 1. Allergic to any ingredient of the product; 2. Suffering from interstitial lung diseases (ILD) other than IPF, including but not limited to: any other type of interstitial pneumonia; lung diseases related to exposure to fibrogenic agents or other environmental toxins or drugs (such as amiodarone, bleomycin, or methotrexate); other types of occupational lung diseases; granulomatous lung diseases; systemic diseases including vasculitis, infectious diseases (i.e., tuberculosis), and connective tissue diseases, or a history of prior pulmonary resection; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: Patients must meet all of the following criteria to be eligible for this trial: 1. Gender unrestricted, aged between 40 and 75 years old (inclusive); 2. Diagnosed with IPF according to the 2022 Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline. 3. In the 3 months prior to administration, determined by the investigator to have stable disease, with diffusing capacity of the lung for carbon monoxide (DLCO) between 30% and 79% of the predicted value (adjusted for Hb), FVC/predicted ≥50%, and forced expiratory volume in one second (FEV1)/FVC ≥0.70; 4. Allowed to enroll are the patients who have been treated according to the current standard treatment plan for IPF and have maintained the treatment for at least 3 months; 5. Good compliance, able to understand and cooperate with pulmonary function test procedures, willing to participate voluntarily in the trial according to the protocol requirements, and understand and sign the informed consent form voluntarily. Exclusion Criteria: Patients meeting any of the following criteria are not eligible for this trial: 1. Allergic to any ingredient of the product; 2. Suffering from interstitial lung diseases (ILD) other than IPF, including but not limited to: any other type of interstitial pneumonia; lung diseases related to exposure to fibrogenic agents or other environmental toxins or drugs (such as amiodarone, bleomycin, or methotrexate); other types of occupational lung diseases; granulomatous lung diseases; systemic diseases including vasculitis, infectious diseases (i.e., tuberculosis), and connective tissue diseases, or a history of prior pulmonary resection; 3. During the screening period, having any of the following pulmonary diseases: asthma, pulmonary embolism, pneumothorax; lung cancer, obstructive bronchitis, or other active lung diseases; a known history of immune system diseases (such as thymic diseases, systemic lupus erythematosus); acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 4. Chest HRCT during the screening period shows emphysema area \> fibrosis area; 5. Previously received stem cell therapy or intolerant to cell therapy; 6. Received unstable standard of care for IPF within the 3 months prior to screening; 7. Used non-biological drugs with cell proliferation inhibition or immunosuppressive/immunomodulatory effects during the 3 months prior to screening, such as Mycophenolate Mofetil, cyclophosphamide, tacrolimus, and JAK inhibitors, as well as other Chinese herbal medicines with immunomodulatory effects; 8. Used biologics such as rituximab, TNF-α monoclonal antibodies, and IFN-γ monoclonal antibodies within the 6 months prior to screening; 9. Used anticoagulant drugs, sildenafil, bosentan, macitentan, imatinib, and other drugs for treating IPF within the 4 weeks prior to screening; 10. Participated in interventional clinical studies within the 3 months or within the half-life of 5 drugs (whichever is longer) before screening; 11. Hospitalized 2 or more times in the past year due to acute exacerbation of IPF; 12. Had a lung infection within the past month; 13. Had a history of invasive or non-invasive mechanical ventilation, or currently require oxygen therapy (oxygen therapy time \>15 h/d); 14. Smoked within the past 3 months or cannot quit smoking during the trial; 15. The expected survival period may be less than 1 year judged by investigator; 16. Laboratory tests meet any of the following criteria: white blood cell count less than 3.5×109/L or neutrophils less than 1.5×109/L for any reason; hemoglobin (HGB) ≤90 g/L; fibrinogen (FIB) ≤0.5×LLN; alanine aminotransferase (ALT) \>2×ULN, aspartate aminotransferase (AST) \>2×ULN, total bilirubin (TBIL) \>1.5×ULN, direct bilirubin (DBIL) \>1.5×ULN, blood creatinine (Cr) \>1.5×ULN; 17. Evidence suggests that the subject currently has digestive system, urinary system, cardiovascular system, hematological system, nervous system, psychiatric, or metabolic diseases that may affect safety, such as severe kidney disease requiring blood dialysis or peritoneal dialysis; advanced hepatitis or cirrhosis; severe heart failure (NYHA Grade III and IV); poorly controlled hypertension (≥180/100 mmHg); severe pulmonary heart disease or pulmonary arterial hypertension considered by the investigators to affect the evaluation of the trial results; 18. Have various malignant tumors or a history of malignant tumors; 19. 12-lead electrocardiogram shows severe arrhythmias (such as ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, and atrial flutter) or degree II and above atrioventricular block; 20. Positive results in serological tests (HBsAg, HCV antibodies, HIV antibodies, syphilis spirochete antibodies), among which carriers of hepatitis B virus, stable patients with hepatitis B (DNA titer ≤2000 IU/mL or copy number \<1000 copies/mL) after drug treatment, and cured patients with hepatitis C (negative HCV RNA) can be enrolled after being judged eligible by the investigator; 21. Pregnant or lactating women, or those with a positive result in the screening period for beta-human chorionic gonadotropin (β-HCG) testing; or male subjects of childbearing potential and female subjects of childbearing age who are unable and unwilling to take effective non-drug contraceptive measures during the study and 6 months after the end of the study; 22. Subjects deemed inappropriate for entry into this study by the investigator.

Treatments Being Tested

DRUG

VUM02 Injection

VUM02 Injection will be administered intravenously every 3 days for a total of 3 doses.

Locations (4)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Peking University Third Hospital
Beijing, China
West China Hospital of Sichuan University
Chengdu, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
The First People's Hospital of Kashi Prefecture, Xinjiang
Kashgar, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06230822), the sponsor (Wuhan Optics Valley Vcanbiopharma Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06230822 clinical trial studying?

This study is a single-arm, multiple-dose, dose-escalation, open-label multicenter clinical trial, aiming to evaluate the safety, tolerability, and preliminary efficacy of VUM02 Injection for treatment of idiopathic pulmonary fibrosis (IPF). VUM02 Injection (Human Umbilical Cord Tissue-derived Mesenchymal Stem Cells Injection, hUCT-MSC) is an allogeneic cell therapy product comprising culture-expanded Mesenchymal Stem Cells derived from the human umbilical cord tissue. The product is cryopreserved with the amount of 5 x 10\^7 cells per 10 mL per bag (5 x 10\^6 cells/mL). This study is a multip… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06230822?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06230822?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06230822. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06230822. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.