drugset / Trial / NCT05035862
Mechanisms of Interferon Gamma-primed Mesenchymal Stromal Cells (MSCs) for Moderate-to-severe Persistent Asthma
Phase 1
Terminated
1 enrolled
Emory University
Ossium Health, Inc. · collabThe Marcus Foundation · collab
NaSingle-groupOpen-labelBasic science
Summary
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.
Timeline
- Start
- 2022-03-16
- Primary completion
- 2022-12-16
- Completion
- 2022-12-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Interferon gamma (IFNγ)-primed human bone marrow-derived mesenchymal stromal cells | Cell therapy | 2e+06 cells/kg | Intravenous |
| Subject | Interferon gamma (IFNγ)-primed human bone marrow-derived mesenchymal stromal cells | Cell therapy | 5e+06 cells/kg | Intravenous |
| Background | Prednisone | Other / unclassified | 1 mg/kg | — |
| Background | Salbutamol | Unknown | 90 ug | Inhaled |