A Study to Evaluate the Safety of Bone Marrow-Derived Stem Cells for Interstitial Lung Disease in Patients with Connective Tissue Disorders

Overview

About this study

The purpose of this study is to assess the safety of mesenchymal stem cells in patients with Interstitial Lung Disease (ILD) associated with Connective Tissue Disorders (CTD).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria:

  • Adults over 18 years of age and less than 80 years old.
  • Both female and male.
  • Patients with new diagnosis of interstitial lung disease associated with connective tissue disorders, 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 (SO^2 < 88% at rest).
  • Clinical assessment that indicates active chronic infections such as osteomyelitis or active 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 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:
    • HIV;
    • Hepatitis B or C.
  • Clinically significant abnormal CBC, creatinine or AST/ALT at screening per investigators clinical discretion.
  • Pregnant or breast feeding.
  • Unwilling to agree to use acceptable contraception methods during participation in the trial.
  • Inability to provide informed consent.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Andy Abril, M.D.

Open for enrollment

Contact information:

Laura Akhtar CCRP

127or7839648

Akhtar.Laura@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20461631

Mayo Clinic Footer