Actively Recruiting
Safety of Endobronchial Administration of Allogeneic Mesenchymal Stromal Cells in Patients With Chronic Lung Allograft Dysfunction: A Randomized Controlled Trial
Led by Instituto De Investigación Sanitaria Puerta De Hierro-Segovia De Arana · Updated on 2024-07-26
12
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
I
Instituto De Investigación Sanitaria Puerta De Hierro-Segovia De Arana
Lead Sponsor
M
Ministerio de Ciencia e Innovación, Spain
Collaborating Sponsor
AI-Summary
What this Trial Is About
Lung transplantation is increasingly used for patients with advanced respiratory diseases, but long-term survival is limited by chronic lung allograft dysfunction, a complex condition without effective treatment. Researchers are assessing the safety of using mesenchymal stem cells, which have immunomodulatory properties, as a potential treatment for this condition. This is a Phase 1, open-label, randomized clinical trial sponsored by Instituto De Investigaci f3n Sanitaria Puerta De Hierro-Segovia De Arana. Participants will be randomly assigned to receive either endobronchial administration of allogeneic mesenchymal stem cells or no intervention. The treatment involves delivering 10 sup MSCs per kilogram into each transplanted lung, with doses given 4 weeks apart. The study includes a control group and is designed to evaluate safety over time. During the study, participants will be monitored for early adverse events within 24 hours and any adverse events occurring up to one year after randomization. Researchers will collect data on safety and tolerability through clinical assessments and follow-up visits. The total study duration spans at least one year, allowing for thorough observation of treatment effects and participant health.
CONDITIONS
Brief Title
Safety of Endobronchial Mesenchymal Stromal Cells in the Treatment of Chronic Lung Allograft Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must provide signed informed consent.
- Adults 18 years of age or older at enrollment.
- Recipients of a single or double lung transplant.
- Diagnosed with bronchiolitis obliterans syndrome stage 0p or higher within the last 6 months, defined by specific lung function criteria.
You will not qualify if you...
- History of lobar or heart-lung transplantation.
- Presence of active infection at the time of inclusion.
- Untreated active acute rejection.
- History of cancer except certain skin cancers.
- Systemic autoimmune diseases.
- Active HIV, hepatitis B or C infection.
- Proximal airway stenosis.
- Pregnancy.
- Poor performance status (confined to bed or chair more than half the day).
- Estimated survival less than 3 months.
- Known allergy to components used in the stem cell production.
- Any condition that may compromise participation as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 weeks
Participants receive endobronchial administration of mesenchymal stromal cells, with doses given 4 weeks apart.
2 visits (in-person) 4 weeks apart
Duration - Up to 1 year since randomization
Participants are monitored for adverse events and safety outcomes for up to one year after treatment.
Regular follow-up visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Spain
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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