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

Interstitial Lung Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03929120
• Other study ID #: 18-007216
• Status: Completed
• Phase: Phase 1
• Start date: November 5, 2019
• Est. completion date: February 2, 2022

Study information

• Verified date: April 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2, 2022
• Est. primary completion date: July 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Connective Tissue Diseases
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Number of adverse events reported with infusion of each intravenous Mesenchymal Stem Cells (MSC) dose	6 months

External Links

•   Mayo Clinic Clinical Trials