Actively Recruiting
Safety, Tolerability and Efficacy of VUM02 Injection in Treatment of Idiopathic Pulmonary Fibrosis (IPF)
Led by Wuhan Optics Valley Vcanbiopharma Co., Ltd. · Updated on 2024-02-20
9
Participants Needed
4
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety, Tolerability and Efficacy of VUM02 Injection in Treatment of Idiopathic Pulmonary Fibrosis (IPF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 40 to 75 years old (inclusive), any gender
- Diagnosed with idiopathic pulmonary fibrosis (IPF) according to official clinical guidelines
- Stable disease in the past 3 months with lung function: DLCO 30%-79% predicted, FVC ≥50%, FEV1/FVC ≥0.70
- Treated with current standard IPF therapy and maintained treatment for at least 3 months
- Good compliance, able to understand and cooperate with tests, willing to participate and sign consent
You will not qualify if you...
- Allergy to any ingredient of the study product
- Other interstitial lung diseases or lung diseases related to toxins, drugs, or systemic diseases
- Active lung diseases during screening such as asthma, pulmonary embolism, pneumothorax, lung cancer, or obstructive bronchitis
- Emphysema area greater than fibrosis area on chest HRCT
- Previous stem cell therapy or intolerance to cell therapy
- Unstable standard care for IPF within 3 months prior to screening
- Use of immunosuppressive or cell proliferation-inhibiting drugs within specified periods prior to screening
- Recent participation in other interventional clinical studies
- Frequent hospitalizations for acute IPF exacerbation
- Recent lung infection, history of mechanical ventilation, or needing oxygen therapy over 15 hours per day
- Smoking within past 3 months or inability to quit during the trial
- Expected survival less than 1 year
- Abnormal laboratory test results as specified
- Presence of severe diseases in digestive, urinary, cardiovascular, hematological, nervous, psychiatric, or metabolic systems
- History or presence of malignant tumors
- Severe arrhythmias or significant heart conduction abnormalities
- Positive serological tests for certain infections except stable or cured hepatitis
- Pregnant or lactating women and those unable or unwilling to use effective contraception
- Any other conditions deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Peking University Third Hospital
Beijing, China
Actively Recruiting
2
West China Hospital of Sichuan University
Chengdu, China
Actively Recruiting
3
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Actively Recruiting
4
The First People's Hospital of Kashi Prefecture, Xinjiang
Kashgar, China
Actively Recruiting
Research Team
Y
Yuan Peng, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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