Efficacy and Safety Study of HLCM051(MultiStem®) for Pneumonic Acute Respiratory Distress Syndrome

Summary

The primary object of this clinical study is to investigate the efficacy of HLCM051 in patients with ARDS caused by pneumonitis.

Timeline

Start

2019-01-01

Primary completion

2021-12-14

Completion

2021-12-14

Outcome

Missed primary endpoint

paper LS mean difference [95% CI], 5.4 [- 1.9 to 12.8]; p = 0.1397 PMID 37608287 ↗

Publications

• Ichikado K, Kotani T, Kondoh Y, Imanaka H, Johkoh T, Fujimoto K, Nunomiya S, Kawayama T, Sawada M, Jenkins E, Tasaka S, Hashimoto S. Clinical efficacy and safety of multipotent adult progenitor cells (invimestrocel) for acute respiratory distress syndrome (ARDS) caused by pneumonia: a randomized, open-label, standard therapy-controlled, phase 2 multicenter study (ONE-BRIDGE). Stem Cell Res Ther. 2023 Aug 22;14(1):217. doi: 10.1186/s13287-023-03451-z.

Drugs

Indications