drugset / Trial / NCT04961658
Advanced Mesenchymal Enhanced Cell THerapY for SepTic Patients
Non-randomizedSequentialOpen-labelTreatment
Summary
Bacterial sepsis occurs in patients with severe infections. The condition is caused by toxic substances (toxins) released from bacteria and the patient's elevated inflammatory response to those toxins. In preclinical studies, human mesenchymal stromal cells (MSCs) have been proven to modulate host inflammation in infections, including sepsis. The purpose of the Phase I, open label, dose escalation safety trial is to determine whether escalating doses of enhanced MSCs (GEM00220) are safe and well tolerated in patients with septic shock.
Timeline
- Start
- 2021-08-11
- Primary completion
- 2023-08-10
- Completion
- 2024-01-08
Outcome
Outcome not reported
Stopped (Business): “Funding Decision”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GEM00220 | Unknown | 15 cells | Intravenous |
| Subject | GEM00220 | Unknown | 60 cells | Intravenous |
| Subject | GEM00220 | Unknown | 150 cells | Intravenous |