- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03929120
Recruitment Status Recruiting
First Posted April 26, 2019
Last update posted August 25, 2020
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).
|Experimental: Interstitial Lung Disease with Connective Tissue Disorder
Subjects with Interstitial Lung Disease (ILD) associated with Connective Tissue Disorder (CTD) will receive a new treatment called Allogeneic (coming from a healthy donor) Bone Marrow Derived Mesenchymal Stem Cells (BMD-MSCs)
Biological: Allogeneic Bone Marrow Derived Mesenchymal Stem Cells (BMD-MSCs)
Subjects will be treated with regular standard of care plus 0.5-1 million MSC/Kg intravenously.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- 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
- 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 immunodeficiency virus (HIV), Hepatitis B or C - Abnormal complete blood count (CBC), creatinine, Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) at screening - Pregnant or breast feeding - Unwilling to agree to use acceptable contraception methods during participation in the trial - Inability to provide informed consent
Contact: Laura Akhtar (904) 953-9648 Akhtar.email@example.com
United States, Florida
Mayo Clinic in Florida
Principal Investigator: Andy Abril, MD Mayo Clinic