NCT06514378 Safety of Endobronchial Mesenchymal Stromal Cells in the Treatment of Chronic Lung Allograft Dysfunction
| NCT ID | NCT06514378 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Instituto De Investigación Sanitaria Puerta De Hierro-Segovia De Arana |
| Condition | Chronic Lung Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2023-09-19 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2023-09-19 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Lung transplantation is the only therapeutic alternative for more and more patients with respiratory diseases in their most advanced stages. The most limiting factor to achieve long term survival si chronic lung allograft dysfunction, a multifactorial disease without an effective treatment. The immunomodulatory capacity of mesenchymal stem cells enables them to be a potential therapeutic agent for this condition. The objective of this study is to assess the safety of endobronchial administration of allogeneic MSCs in patients with chroniclung allograft dysfunction.
Eligibility Criteria
Inclusion Criteria: Patients should have signed written informed consent. Adult patients ≥18 years of age at the time of enrolment Patients recipients of a uni or bipulmonary transplant An established diagnosis of BOS ≧ 0p (FEV1≤90% and / or FEF 25-75% ≤ of the baseline value with no other justifying cause) in the last 6 months. Exclusion Criteria: * History of lobar transplantation History of heart-lung transplantation Active infection at the time of inclusion. Active Acute Rejection not treated at the time of inclusion. Oncological history (except cutaneous basal cell or carcinoma in situ) Systemic autoimmune diseases. Active HIV / HBV / HCV infection (confirmed by serology or PCR) Proximal airway stenosis Pregnancy Performance status 3 or 4 (confined to bed or chair for more than 50% of waking hours, able only to perform some self-care activities) Estimated survival less than 3 months. Known hypersensitivity to components used in the production of allogeneic MSCs. Any circumstance that, in the opinion of the investigator, compromises the patient's ability to participate in the clinical trial.
Frequently Asked Questions
Who can join the NCT06514378 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Lung Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06514378 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06514378 currently recruiting?
Yes, NCT06514378 is actively recruiting participants. Visit ClinicalTrials.gov or contact Instituto De Investigación Sanitaria Puerta De Hierro-Segovia De Arana to inquire about joining.
Where is the NCT06514378 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT06514378 clinical trial?
NCT06514378 is sponsored by Instituto De Investigación Sanitaria Puerta De Hierro-Segovia De Arana. The trial plans to enroll 12 participants.