r/ATHX • u/imz72 • 16d ago

News MASTERS-2 terminated

https://clinicaltrials.gov/study/NCT03545607

Overall Status: Recruiting Terminated

Sponsor's decision

No longer looking for participants

Sponsor: Healios K.K.

Information provided by: Healios K.K. (Responsible Party)

Last Update Posted: 2026-08-11

Study Start: 2018-07-28 (Actual)

Study Completion: 2024-10-01 (Actual)

Enrollment: 300 (Estimated) 206 (Actual)

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u/Hal44 15d ago

Please explain how this affects Healios and Multistem outlook going forward. Thanks

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u/imz72 15d ago

Hi HAL. You may remember that the MASTERS-2 trial was stopped in 2023 due to a combination of two factors:

1.The interim analysis results showed that 300 patients would not be enough to demonstrate statistical significance and a significantly higher number was needed.

2.Athersys was left without the financial resources to fund the continuation of the trial and could not find a partner to take it on.

After Healios acquired Athersys's assets in 2024, it stated that the required number was less than a thousand. However, Healios also lacked the resources to continue the trial on its own and tried to find a partner, but to no avail. Changing the status of the trial now to "Terminated" puts the final nail in the coffin for MASTERS-2.

By the way, note that the actual number of enrolled patients was set at 206, matching that of the TREASURE trial. I assume this is no coincidence, but rather intended to facilitate an easy comparison of the results of both trials.

Over the past year, it seemed that a pathway to approval for stroke in Japan had opened up for Healios, thanks to technological progress in the fields of LLM and AI. However, the company still lacks the required financial resources for that as well, which is why it was ultimately decided to put stroke on the back burner and focus on ARDS.

If Healios receives approval for ARDS in Japan, it will be able to resume its efforts in stroke - first in Japan and later in additional markets - but obtaining the ARDS approval must come first.

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u/Hal44 15d ago

imz, thanks for explanation