A Study to Evaluate the Safety of Bone Marrow-Derived Stem Cells for Interstitial Lung Disease in Patients with Connective Tissue Disorders

Overview

Información sobre este estudio

The purpose of this study is to assess the safety of mesenchymal stem cells in patients with Interstitial Lung Disease (ILD) associated with Connective Tissue Disorders (CTD).

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:

  • Adults over 18 years of age and less than 80 years old.
  • Both female and male.
  • Patients with new diagnosis of interstitial lung disease associated with connective tissue disorders, ANCA associated vasculitis or idiopathic pneumonia with autoimmune features (IPAF) or established diagnosis of ILD associated with CTD under conventional therapy for at least 6 months but less than 24 months, with no evidence of improvement.
  • Competent and able to provide written informed consent, and ability to comply with protocol.

Exclusion Criteria:

  • Patients with interstitial lung disease without evidence of a concomitant rheumatologic autoimmune disorder.
  • Exposure to rituximab or cyclophosphamide on the previous 2 months.
  • Severe interstitial lung disease defined by the presence of severe hypoxemia at rest (SO^2 < 88% at rest).
  • Clinical assessment that indicates active chronic infections such as osteomyelitis or active TB, or acute infections such as pneumonia, active bronchitis, cellulitis, etc. or active solid tumors or hematologic malignancies.
  • Previous treatment with mesenchymal stem cells.
  • Clinically significant medical conditions within the six months before administration of MSCs; e.g., myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
  • Medical history of:
    • HIV;
    • Hepatitis B or C.
  • Clinically significant abnormal CBC, creatinine or AST/ALT at screening per investigators clinical discretion.
  • Pregnant or breast feeding.
  • Unwilling to agree to use acceptable contraception methods during participation in the trial.
  • Inability to provide informed consent.

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Andy Abril, M.D.

Cerrado para la inscripción

Contact information:

Veronica Munet Diaz CCRP

Munet-Diaz.Veronica@mayo.edu

More information

Publicaciones

Publications are currently not available
.
CLS-20461631

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