Related Experiment Video
Updated: Feb 13, 2026
11:28
3D Microtissues for Injectable Regenerative Therapy and High-throughput Drug Screening
Published on: October 4, 2017
10.8K
[Current status of development for regenerative cell therapy, SB623]
1SanBio Co., Ltd.
Nihon Yakurigaku Zasshi. Folia Pharmacologica Japonica
|March 13, 2018
Summary
SB623 cell transplantation shows promise for chronic ischemic stroke repair. This regenerative medicine approach demonstrated safety and significant clinical improvements in a Phase I/IIa study.
Area of Science:
- Regenerative Medicine
- Neuroscience
- Clinical Neurology
Background:
- Chronic ischemic stroke leads to significant brain damage.
- Current treatments for chronic stroke have limited efficacy.
- SB623 is an investigational regenerative medicine product.
Purpose of the Study:
- To evaluate the safety and clinical outcomes of SB623 cell transplantation in patients with chronic ischemic stroke.
- To assess the potential of SB623 to promote brain repair after stroke.
Main Methods:
- An open-label, single-arm Phase I/IIa clinical study was conducted.
- 18 patients with chronic ischemic stroke were enrolled in the United States.
- Surgical transplantation of SB623 was performed, followed by a one-year follow-up period.
Main Results:
- Significant improvements were observed in mean scores across the European Stroke Scale, National Institutes of Health Stroke Scale, and Fugl-Meyer Assessment.
- No side effects or serious treatment-emergent adverse events related to SB623 cell transplantation were reported.
- SB623 demonstrated a favorable safety profile and potential efficacy in improving functional outcomes.
Conclusions:
- SB623 cell transplantation is a safe and effective therapeutic option for chronic ischemic stroke.
- Regenerative medicine with SB623 holds potential for brain repair.
- Ongoing clinical studies in Japan and the US aim to accelerate development and patient access.
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