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| Name | Class |
|---|---|
| Ministerio de Ciencia e Innovación, Spain | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal stem cells | Biological | Endobronchial administration of 10⁶ MSCs/kg in each transplanted lung, 4 weeks apart. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early onset adverse events | Incidence of early onset (24h) adverse events following MSCs administration: desaturation, hypotension, radiological infiltrates, fever or changes in oxygen therapy requirements. | 24 hours |
| Adverse events | 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). | One year since randomization |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Puerta de Hierro Majadahonda | Recruiting | Madrid | Spain |
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