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出境医 / 临床实验 / Allogeneic Bone Marrow Mesenchymal Stem Cells for Patients With Interstitial Lung Disease (ILD) & Connective Tissue Disorders (CTD)

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

Study Description
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 : October 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
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
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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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

Contacts
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Contact: Veronica Munet-Diaz (904) 953-3375 Munet-Diaz.Veronica@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
Tracking Information
First Submitted Date  ICMJE April 24, 2019
First Posted Date  ICMJE April 26, 2019
Last Update Posted Date June 7, 2021
Actual Study Start Date  ICMJE November 5, 2019
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2019) 		Adverse Events [ Time Frame: 6 months ]
Number of adverse events reported with infusion of each intravenous Mesenchymal Stem Cells (MSC) dose
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Allogeneic Bone Marrow Mesenchymal Stem Cells for Patients With Interstitial Lung Disease (ILD) & Connective Tissue Disorders (CTD)
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Interstitial Lung Disease
  • Connective Tissue Diseases
Intervention  ICMJE 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.
Study Arms  ICMJE 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)
Intervention: Biological: Allogeneic Bone Marrow Derived Mesenchymal Stem Cells (BMD-MSCs)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 24, 2019) 		10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Veronica Munet-Diaz (904) 953-3375 Munet-Diaz.Veronica@mayo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03929120
Other Study ID Numbers  ICMJE 18-007216
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Andy Abril, M.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andy Abril, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP