drugset / Trial / NCT05027815
Tregs for the Treatment of Acute Respiratory Distress Syndrome (ARDS) Associated With COVID-19 (regARDS)
Phase 1
Terminated
7 enrolled
Jeffrey Bluestone
Immune Tolerance Network (ITN) · collabNational Institute of Allergy and Infectious Diseases (NIAID) · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
In patients with Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19 inflammatory syndrome, the administration of Treg cells is a novel treatment complementary to other pharmacologic interventions that potentially can reduce lung inflammation, promote lung tissue repair, and significantly improve clinical outcomes. This trial is to evaluate the impact of a single IV dose of cePolyTregs given to ARDS patients with COVID-19 inflammatory syndrome.
Timeline
- Start
- 2021-09-23
- Primary completion
- 2022-03-02
- Completion
- 2022-03-02
Outcome
Outcome not reported
Stopped (Enrollment): “Decrease in COVID-19 cases made further enrollment infeasible.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cryopreserved Ex Vivo Expanded Polyclonal CD4+CD127lo/-CD25+ T Regulatory Cells | Cell therapy | 1e+08 cells | Intravenous |
| Subject | Cryopreserved Ex Vivo Expanded Polyclonal CD4+CD127lo/-CD25+ T Regulatory Cells | Cell therapy | 2e+08 cells | Intravenous |
| Subject | Cryopreserved Ex Vivo Expanded Polyclonal CD4+CD127lo/-CD25+ T Regulatory Cells | Cell therapy | 4e+08 cells | Intravenous |