Status:
RECRUITING
Safety of Endobronchial Mesenchymal Stromal Cells in the Treatment of Chronic Lung Allograft Dysfunction
Lead Sponsor:
Instituto De Investigación Sanitaria Puerta De Hierro-Segovia De Arana
Collaborating Sponsors:
Ministerio de Ciencia, Innovación y Universidades
Conditions:
Chronic Lung Disease
Lung Transplant Rejection
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06514378
Start Date
September 19 2023
End Date
March 31 2026
Last Update
July 26 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Spain