Allogeneic Bone Marrow Mesenchymal Stem Cells for Patients With Interstitial Lung Disease (ILD) &… (NCT03929120) | Clinical Trial Compass
CompletedPhase 1
Allogeneic Bone Marrow Mesenchymal Stem Cells for Patients With Interstitial Lung Disease (ILD) & Connective Tissue Disorders (CTD)
United States10 participantsStarted 2019-11-05
Plain-language summary
Researchers are trying to find out more about the safety of a new treatment, Allogeneic (coming from a healthy donor) Bone Marrow Derived Mesenchymal Stem Cells (BMD-MSCs) which is still experimental, for Interstitial Lung Disease (ILD) associated with Connective Tissue Disorder (CTD).
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Adults over 18 years of age and less than 80 years of age
* Both female and male
* Patients with new diagnosis of interstitial lung disease associated with connective tissue disorders, Antineutrophil cytoplasmic antibodies (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 (SO2 \< 88% at rest)
* Clinical assessment that indicates active chronic infections such as osteomyelitis or active tuberculosis (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 BMD-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 human immunodeficienc…