Allogeneic Bone Marrow Mesenchymal Stem Cells for Patients With Interstitial Lung Disease (ILD) & Connective Tissue Disorders (CTD)

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Interstitial Lung Disease, Connective Tissue Diseases

Intervention / Treatment
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* Biological: Allogeneic Bone Marrow Derived Mesenchymal Stem Cells (BMD-MSCs)


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interstitial Lung Disease with Connective Tissue Disorder<br>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)<br>* Subjects will be treated with regular standard of care plus 0.5-1 million MSC/Kg intravenously.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of adverse events reported with infusion of each intravenous Mesenchymal Stem Cells (MSC) dose | 6 months |