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Tests treatment safety and results for Anti-MDA5 Positive Dermatomyositis-Associated RP-ILD
Official title Nebulized MSC-Exos for Anti-MDA5+ RP-ILD: Safety and Efficacy Trial
ClinicalTrials.gov ID: NCT06919380
What this study is testing
What is MSC-exos Nebulization Therapy?
MSC-exos Nebulization Therapy is an investigational medicine, given as an once-daily inhaled treatment, being studied as a potential treatment for anti-mda5 positive dermatomyositis-associated rp-ild.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Objective: To assess the safety, tolerability, and efficacy of nebulized MSC-exos-P1 in patients with anti-MDA5 positive dermatomyositis-associated rapidly progressive interstitial lung disease (RP-ILD). Design: Prospective interventional trial with 10 eligible patients aged 18-75, meeting criteria for RP-ILD and anti-MDA5 positivity.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients are eligible for inclusion if they meet all of the following criteria:
- Positive for anti-MDA5 antibody dermatomyositis (according to the "Chinese Expert Consensus on the Diagnosis and Treatment of Anti-MDA5 Positive...
- Pulmonary lesions meet the diagnostic criteria for RP-ILD.
You likely can't join if
- Patients who meet any of the following criteria will be excluded from this study:
- Pregnant or breastfeeding women, or women planning pregnancy during the study, or men unwilling to use contraceptive measures throughout the trial...
- History of severe allergies or allergies to the main active ingredients of the trial medication;
- Currently suffering from severe pulmonary infections, pneumothorax, or large pleural effusions;
- Currently diagnosed with pulmonary embolism;
- Currently undergoing mechanical ventilation through tracheal intubation;
See the full eligibility criteria
- Patients are eligible for inclusion if they meet all of the following criteria:
- Positive for anti-MDA5 antibody dermatomyositis (according to the "Chinese Expert Consensus on the Diagnosis and Treatment of Anti-MDA5 Positive Dermatomyositis (2023 Edition)");
- Pulmonary lesions meet the diagnostic criteria for RP-ILD.
- Patients who meet any of the following criteria will be excluded from this study:
- Pregnant or breastfeeding women, or women planning pregnancy during the study, or men unwilling to use contraceptive measures throughout the trial period;
- History of severe allergies or allergies to the main active ingredients of the trial medication;
- Currently suffering from severe pulmonary infections, pneumothorax, or large pleural effusions;
- Currently diagnosed with pulmonary embolism;
- Currently undergoing mechanical ventilation through tracheal intubation;
- Currently undergoing extracorporeal life support treatments such as ECMO, CRRT, PMX-DHP, or plasma exchange;
- Currently suffering from severe heart failure, liver, or kidney insufficiency;
- Expected to undergo lung transplantation in the near future;
- Currently suffering from lung cancer or pulmonary nodules suspected to be early-stage lung cancer;
- Suffering from primary immunodeficiency diseases;
- Currently suffering from active infectious diseases, including but not limited to HIV positivity, active tuberculosis, etc., and deemed unsuitable for this trial by the researcher;
- Use of other trial medications within 28 days before starting treatment, which the researcher judges may interfere with the safety and how well it works assessment of this trial medication;
- Other situations deemed not in the best interest of the subject or unsuitable for participation in this study by the researcher, such as poor compliance.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.