NCT06514378RecruitingPhase 1
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.
Instituto De Investigación Sanitaria Puerta De Hierro-Segovia De Arana1 site in 1 country12 target enrollmentStarted: September 19, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Early onset adverse events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control
No Intervention
Treatment group
Experimental
Intervention: Mesenchymal stem cells (Biological)
Outcomes
Primary Outcomes
Early onset adverse events
Time Frame: 24 hours
Incidence of early onset (24h) adverse events following MSCs administration: desaturation, hypotension, radiological infiltrates, fever or changes in oxygen therapy requirements.
Adverse events
Time Frame: One year since randomization
Incidence of adverse events of special interest since randomization: lower respiratory tract infections, acute rejection (as defined by the presence of A1-A4 o B1R, B2R in biopsy), BO worsening (as measured by \>10% decline in FEV1 from baseline).
Secondary Outcomes
No secondary outcomes reported
Investigators
David Gomez de Antonio
Head of Research Group
Instituto De Investigación Sanitaria Puerta De Hierro-Segovia De Arana
Study Sites (1)
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