TERMINATED

Mechanisms of Interferon Gamma-primed Mesenchymal Stromal Cells (MSCs) for Moderate-to-severe Persistent Asthma

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Conditions

Asthma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is a two strata, dose escalation Phase I clinical trial designed to assess the safety and determine the maximal tolerated dose (MTD) of allogenic cord tissue derived MSCs (cMSCs, stratum 1) and allogeneic, interferon-γ primed bone marrow MSCs (γMSCs, stratum 2). Each stratum is designed to independently accrue 3 children at a dose level 1 of 2x106 cells/kg and 6 children at dose level 2 of 10x106 cells/kg, resulting in 9 children in each stratum. The primary objectives are to determine the safety and toxicity of allogeneic cord tissue derived MSCs and allogeneic interferon-γ primed bone marrow derived MSCs.

Official Title

A Phase 1 Study to Evaluate Safety, Toxicity, and Potential Mechanisms of Interferon Gamma-primed Mesenchymal Stromal Cells (MSCs) for Moderate-to-severe Persistent Asthma

Quick Facts

Study Start:2022-03-16
Study Completion:2022-12-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05035862

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 30 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 through 30 years at the screening visit
  2. * Physician diagnosis of asthma
  3. * Onset of asthma during childhood
  4. * Evidence of atopy, evidenced by allergic rhinitis, aeroallergen sensitization, elevated total immunoglobulin E (IgE) level based on age-dependent reference values, or blood eosinophil counts \> or = 150 cells/microliter
  5. * Moderate-to-severe persistent asthma as defined by the National Asthma Education and Prevention Program Expert Panel Report-4
  6. * A Panel Reactive Antibodies (PRA) test is positive for human leukocyte antigens (HLA) antibodies against the γMSC product
  7. * Oral or injectable corticosteroid use within the two-week period prior to the screening visit.\* Nasal corticosteroids may be used at any time during this trial at the discretion of the study's Medical Principal Investigator.
  8. * Use of medications known to significantly interact with corticosteroid disposition within the two-week period prior to the screening visit, including but not limited to carbamazepine, erythromycin or other macrolide antibiotics, phenobarbital, phenytoin, rifampin, and ketoconazole\*
  9. * Presence of chronic or active lung disease other than asthma, including disorders of the airways or chest wall
  10. * Current smoking or vaping
  11. * History of premature birth before 35 weeks gestation
  12. * Significant medical illness other than asthma, including thyroid disease, diabetes mellitus, sickle cell disease, Cushing's disease, Addison's disease, hepatic disease, immune deficiency, or concurrent medical problems that could require oral corticosteroids during the study or that would place the subject at increased risk of participating in the study
  13. * A history of cataracts, glaucoma, or any other medical disorder associated with an adverse effect to corticosteroids
  14. * History of adverse reactions to corticosteroids or short-acting bronchodilators or any of their ingredients
  15. * Receiving allergen immunotherapy other than an established maintenance regimen (continuous regimen for ≥ 3 months)\*
  16. * Pregnancy or lactation
  17. * If the participant is a female, failure to practice abstinence or use of an acceptable birth control method
  18. * Inability to perform study procedures
  19. * Current participation in another investigational drug trial
  20. * Evidence that the participant may be unreliable or nonadherent, or may move from the clinical center area before trial completion
  21. * Clinically significant deterioration in the level of asthma control, evidenced by:
  22. * Decrease in post-bronchodilator forced expiratory volume in one second (FEV1) of 15% (absolute change) compared to the post-bronchodilator FEV1 value obtained at the baseline visit, or
  23. * An asthma exacerbation
  24. * Clinically significant thrombocytopenia, anemia, neutropenia or elevations in the white blood cell count, assessed at the screening visit
  25. * Positive pregnancy test
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Edwin Horwitz, MD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
United States

Collaborators and Investigators

Sponsor: Emory University

  • Edwin Horwitz, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-16
Study Completion Date2022-12-16

Study Record Updates

Study Start Date2022-03-16
Study Completion Date2022-12-16

Terms related to this study

Keywords Provided by Researchers

  • Asthma

Additional Relevant MeSH Terms

  • Asthma