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RECRUITING
NCT06765733
EARLY_PHASE1

The Study of Safety and Preliminary Efficacy of Aleeto in Patients With MultIple System Atrophy

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

Summary

This is a single-center, prospective, randomized, open-label, blinded outcome assessment (PROBE) study. At the end of the PROBE study, patients who have completed the study may opt to enter the open-label extension (OLE) study. The objective of the study is to evaluate the safety, tolerability and potential preliminary efficacy of Aleeto in the treatment of patients with multiple system atrophy (MSA).

Key Details

Gender

All

Age Range

30 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-05-31

Completion Date

2026-12-31

Last Updated

2025-09-03

Healthy Volunteers

No

Interventions

DRUG

Aleeto

"Aleeto" is a nerve repair protein developed by Darwin Start (Beijing) Biopharmaceutical Co., Ltd. It is a group of specific microenvironmental protein polymers secreted under the emergency conditions of stem cells. It has the advantages of selective assembly, targeted delivery, efficient repair of damaged tissues, high safety, chemical stability, easy storage, etc., and has a powerful neural repair function. According to the groups, patients would be treated with Aleeto via intrathecal injection or intravenous injection.

Locations (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China