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

PHASE1TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

March 16, 2022

Primary Completion Date

December 16, 2022

Study Completion Date

December 16, 2022

Conditions
Asthma
Interventions
DRUG

Albuterol Sulfate

Participants who experience symptoms of cough, dyspnea, chest tightness or wheezing will initiate use of albuterol (2 inhalations, 90 mcg/actuation) by metered dose inhaler (MDI) every 20 minutes for up to 1 hour and then every 4 hours if necessary.

DRUG

Interferon gamma-primed mesenchymal stromal cells (MSCs)

IFNγ-primed bone marrow MSCs at a dose level of 2x106 cells/kg and a dose level of 5x106 cells/kg

DRUG

Prednisone

Prednisone is recommended if the participant uses more than 12 inhalations of albuterol in 24 hours (excluding preventive use before exercise), or if the patient has ongoing symptoms for 48 hours or longer. The recommended prednisone dose for acute exacerbations is 2 mg/kg/day (maximum 60 mg) as a single dose for two days followed by 1 mg/kg/day (maximum 30 mg) as a single dose for two days. All administered doses will be rounded down to the nearest 10 mg.

Trial Locations (1)

30322

Children's Healthcare of Atlanta, Atlanta

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

The Marcus Foundation

OTHER

collaborator

Ossium Health, Inc.

INDUSTRY

lead

Emory University

OTHER

NCT05035862 - Mechanisms of Interferon Gamma-primed Mesenchymal Stromal Cells (MSCs) for Moderate-to-severe Persistent Asthma | Biotech Hunter | Biotech Hunter