Safety of Endobronchial Mesenchymal Stromal Cells in the Treatment of Chronic Lung Allograft Dysfunction

Launched by INSTITUTO DE INVESTIGACIÓN SANITARIA PUERTA DE HIERRO-SEGOVIA DE ARANA · Jul 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a new treatment for patients who have chronic lung allograft dysfunction, a condition that can occur after lung transplantation and severely affects lung function. The researchers are looking at a type of cell called mesenchymal stem cells, which have the potential to help the immune system and improve lung health. The goal is to see if these cells can be safely given to patients through a method called endobronchial administration, which involves delivering the cells directly into the lungs.

To participate in this trial, patients need to be adults aged 18 or older who have received a lung transplant and have been diagnosed with a specific type of lung dysfunction known as Bronchiolitis Obliterans Syndrome (BOS). However, there are some important exclusions, including those with recent infections, certain types of previous transplants, or serious health issues. If eligible, participants can expect to receive the treatment and be closely monitored for any side effects. This trial is currently recruiting participants, and the findings could lead to new ways to help lung transplant patients with chronic dysfunction.

Gender

ALL

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.