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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03929120
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Andy Abril, M.D., Mayo Clinic

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Interstitial Lung Disease Connective Tissue Diseases Biological: Allogeneic Bone Marrow Derived Mesenchymal Stem Cells (BMD-MSCs) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 6 months ]
    Number of adverse events reported with infusion of each intravenous Mesenchymal Stem Cells (MSC) dose


Eligibility Criteria
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Information from the National Library of Medicine

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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Laura Akhtar (904) 953-9648 Akhtar.laura@mayo.edu

Locations
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United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Laura Akhtar         
Principal Investigator: Andy Abril, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Andy Abril, MD Mayo Clinic
More Information
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Additional Information:

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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: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Connective Tissue Diseases
Respiratory Tract Diseases