Allogeneic Bone Marrow Mesenchymal Stem Cells for Patients With Interstitial Lung Disease (ILD) & Connective Tissue Disorders (CTD)
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ClinicalTrials.gov Identifier: NCT03929120 |
Recruitment Status :
Completed
First Posted : April 26, 2019
Last Update Posted : April 20, 2022
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Condition or disease | Intervention/treatment | Phase |
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Interstitial Lung Disease Connective Tissue Diseases | Biological: Allogeneic Bone Marrow Derived Mesenchymal Stem Cells (BMD-MSCs) | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Study to Evaluate the Safety of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for Interstitial Lung Disease in Patients With Connective Tissue Disorders |
Actual Study Start Date : | November 5, 2019 |
Actual Primary Completion Date : | July 27, 2021 |
Actual Study Completion Date : | February 17, 2022 |

Arm | Intervention/treatment |
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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)
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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. |
- Adverse Events [ Time Frame: 6 months ]Number of adverse events reported with infusion of each intravenous Mesenchymal Stem Cells (MSC) dose

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929120
United States, Florida | |
Mayo Clinic in Florida | |
Jacksonville, Florida, United States, 32224 |
Principal Investigator: | Andy Abril, MD | Mayo Clinic |
Responsible Party: | Andy Abril, M.D., Principal Investigator, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT03929120 |
Other Study ID Numbers: |
18-007216 |
First Posted: | April 26, 2019 Key Record Dates |
Last Update Posted: | April 20, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Lung Diseases Lung Diseases, Interstitial Connective Tissue Diseases Respiratory Tract Diseases |