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

NCT03929120 | Completed Phase 1 FDA Drug

• 1 other identifier: 18-007216
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Interstitial Lung Disease; Connective Tissue Diseases

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Number of adverse events reported with infusion of each intravenous Mesenchymal Stem Cells (MSC) dose

  6 months

Study Arms (1)

Interstitial Lung Disease with Connective Tissue Disorder

EXPERIMENTAL

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)

Interventions

Allogeneic Bone Marrow Derived Mesenchymal Stem Cells (BMD-MSCs) BIOLOGICAL

Subjects will be treated with regular standard of care plus 0.5-1 million MSC/Kg intravenously.

Interstitial Lung Disease with Connective Tissue Disorder

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Lung Diseases, Interstitial; Connective Tissue Diseases

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Skin and Connective Tissue Diseases

Study Officials

• Andy Abril, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 26, 2019
• Study Start: November 5, 2019
• Primary Completion: July 27, 2021
• Study Completion: February 2, 2022
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)