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ENDOSC-CLAD
2023-509341-12-00Phase 2Authorised
- Sponsor
- Fundación de Investigación Biomédica Hospital Puerta de Hierro
- Start
- Feb 2023
- Modality
- Stem Cell Therapies → Cell Therapies
- Countries
- 1
01
Overview
Phase 2, randomised, open-label trial in chronic lung allograft dysfunction (CLAD), Bronchiolitis Obliterans Syndrome (BOS) and Lung allograft rejection (LAR) comparing PDH-MSC-TxP plus standard of care with Standard of care (2 arms). Primary endpoints: Incidence of early onset (24h) adverse events following MSCs administration and Incidence of adverse events of special interest. Planned start Feb 2023; status: authorised.
02
Drugs
PDH-MSC-TxP
03
Conditions
chronic lung allograft dysfunction (CLAD)Bronchiolitis Obliterans Syndrome (BOS)Lung allograft rejection (LAR)
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