Study of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke

Summary

Controlled study of stereotactic, intracranial injection of SB623 cells in patients with fixed motor deficits from ischemic stroke

Timeline

Start

2016-03-08

Primary completion

2018-12-05

Completion

2018-12-05

Outcome

Missed primary endpoint

registry analysis (superiority test); SB623 Implant (2.5M) vs SB623 Implant (5.0M) vs Sham Control; p = 0.6743 NCT02448641 ↗

release “The SB623 treatment groups did not demonstrate a statistically significant improvement compared to the control group, and did not meet its primary endpoint.” sumitomo-pharma.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SB623	Cell therapy	2.5 cells	Other
Subject	SB623	Cell therapy	5 cells	Other

Indications