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NOT YET RECRUITING
NCT07476352
EARLY_PHASE1

Expansion Study of ALT001 in Patients With Multiple System Atrophy

Sponsor: yilong Wang

View on ClinicalTrials.gov

Summary

This is an open-label, single-center, prospective, single-arm clinical study. The primary objective of this study is to evaluate the safety, tolerability, and preliminary efficacy of ALT001 in the treatment of patients with multiple system atrophy (MSA) in a real-world setting.

Key Details

Gender

All

Age Range

30 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-05-06

Completion Date

2027-10-30

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

DRUG

ALT001

"ALT001" is a nerve repair protein developed by Darwin Start (Hubei) 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 ALT001 via intrathecal injection or intravenous injection. Intravenous administration of ALT001 was given to each MSA patient in the intervention group, with intravenous administration on days 1 to 14, 31 to 44±3 and 61 to 74±5, and treatment was given once a day. Intravenous administration: ALT001 (130 μg/branch) was dissolved in 100 ml sodium chloride injection, which was completed in about 30-40 minutes.

Locations (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China