Mesenchymal Stem Cell Therapy for Lung Rejection

Overview

Información sobre este estudio

To assess the safety and feasibility of mesenchymal stem cells therapy in patients with transplant related bronchiolitis obliteran syndrome (BOS).

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria

  • Age range: 18 - 75 years
  • Gender: Male of female
  • Target disease or condition: Lung transplant recipients with treatment refractory moderate to severe o-CLAD. Patient must have diagnosis of treatment refractory o-CLAD Subject must have failed a standard immunosuppression regimen for lung transplant recipients and authorization for use of and disclosure of PHI.

Exclusion Criteria

  • Patients with clinically significant illness with manifestations of significant organ dysfunction which in the judgment of the PI or co-investigator would render the study subject unlikely to tolerate the MSC infusion or complete the study.
  • Patient should not have cancer not deemed to be in remission (superficial skin cancer shall not be deemed an exclusion criteria).
  • Evidence or history of autoimmune disorders independent of o-CLAD.
  • Pregnant or breast-feeding.
  • Positive screening for HIV Hepatitis B and Hepatitis C.
  • Evidence of liver dysfunction; Liver profile showing alkaline phosphatase higher than 345 u/L, total bilirubin greater than 1.65 mg/dL, ALT greater than 275 units/L and AST great than 240 units/L.
  • Evidence of significant cardiac dysfunction.
  • Septicemia with high fever and hemodynamic instability.
  • History of CMV pneumonitis.
  • Patients who received any experimental therapy (drug or biologic) for any indication within 12 months of the study enrollment.

More information

Publicaciones

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CLS-20119367

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