Development of a regenerative medicine product (CL2020) using Muse cells

At the management policy briefing session held on December 1, 2021, we explained future development policy for a regenerative medicine product using Muse cells^* (CL2020). We would like to further inform the details as follows.
 

1. Since 2018, we have been conducting a double-blind exploratory clinical trial of cerebral infarction under prior consultation with the Pharmaceuticals and Medical Devices Agency (PMDA), with the aim of filing a conditional and time-limited application for approval of CL2020 for cerebral infarction in Japan during fiscal 2021. In this clinical trial, we were able to confirm the safety of CL2020, and the results showed promising efficacy for motor dysfunction as well.

 

2. We have re-examined the approval process with a view to obtaining approval for CL2020 earlier in Japan and overseas. As a result, we have decided to directly aim for “full approval”, rather than a conditional and time-limited approval, after conducting a validation clinical study, which is larger in scale than the exploratory study. The PMDA shares the same perspective, and we will continue to consult with them as appropriate in order to proceed with the approval process.

 

3. Due to the timeline required for the necessary clinical trials, we do not expect significant bottom-line (profit) contribution before fiscal 2030. However, we will work diligently to deliver CL2020 to patients as soon as possible.

 
* Muse cells (Multilineage-differentiating Stress-Enduring cells)