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A Phase I/III Clinical Study to Evaluate NouvNeu001 Injection for Multiple System Atrophy

NCT07289477 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-04-14

No results posted yet for this study

Summary

This clinical trial is designed to evaluate the safety, tolerability and preliminary efficacy of a single injection of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in patients with Multiple System Atrophy.

Conditions

  • Multiple System Atrophy - Parkinsonian Subtype (MSA-P)

Interventions

BIOLOGICAL

Human Dopaminergic Progenitor Cells

Single injection of Human Dopaminergic Progenitor Cells into the putamen/striatum region of brain.

Sponsors & Collaborators

  • iRegene Therapeutics Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-05
Primary Completion
2027-10-31
Completion
2031-07-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07289477 on ClinicalTrials.gov