Using stem cells to treat chronic lung transplant dysfunction
An Open Label, Randomised, Controlled Clinical Trial to Asses the Safety of Endobronchial Administration of Allogneic Mesenchymal Stromal Cells in Patients With Lung Trasplant Chronic Rejection: Endosclad Study.
This study tests whether giving stem cells through the lungs can help adults with chronic lung transplant problems feel better and improve their health.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto De Investigación Sanitaria Puerta De Hierro-Segovia De Arana Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT06514378 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety of administering allogeneic mesenchymal stem cells (MSCs) through the endobronchial route to patients suffering from chronic lung allograft dysfunction, a condition that significantly limits long-term survival after lung transplantation. The trial focuses on adult patients who have received a lung transplant and have been diagnosed with bronchiolitis obliterans syndrome (BOS). By evaluating the safety of this innovative treatment approach, the study aims to provide insights into the potential of MSCs as a therapeutic option for this challenging condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adult lung transplant recipients diagnosed with bronchiolitis obliterans syndrome.
Not a fit: Patients with active infections, recent acute rejection episodes, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve the management of chronic lung allograft dysfunction and enhance the survival rates of lung transplant recipients.
How similar studies have performed: While the use of mesenchymal stem cells in various conditions has shown promise, this specific approach for chronic lung allograft dysfunction is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Madrid
- Hospital Universitario Puerta de Hierro Majadahonda — Madrid, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.