The Safety,Tolerability, Efficacy of XS411 Cell Injection for the Treatment of Primary Parkinson's Disease

StatusActive, Not Recruiting
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later Apr 30, 2026 → Jul 2027
Primary endpoint added 1 → 2 primary endpoints
See other at-risk trials from XellSmart Therapeutics (Shanghai) Co., Ltd.

Record History

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  1. Primary completion pushed from Apr 30, 2026 to Jul 2027 Show 12 more changesShow less
    • Primary endpoint(s) modified
    • Phase changed: Phase 1 → Phase 1/2
    • Sponsor changed: XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd. to XellSmart Therapeutics (Shanghai) Co., Ltd.
    • Enrollment closed, study ongoing
    • Final enrollment: 39 participants (planned 12)
    • Study completion moved earlier from Aug 30, 2029 to Jul 2028
    • Interventions modified
    • Trial arms changed: 3 → 4
    • Eligibility criteria expanded, about 48 words
    • Secondary endpoints expanded, about 8 words
    • Site details revised
    • Study title expanded, about 1 word
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 25, 2025 to Aug 5, 2025
    • Site details revised
    • Collaborators expanded, about 3 words
    v2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
This Phase I clinical trial is designed to evaluate the safety, tolerability of a single dose of XS411 (derived dopaminergic neural progenitor cell injection) in patients with primary Parkinson's disease. This Phase II clinical trial is designed to evaluate the safety, tolerability and Efficacy of XS411 (derived dopaminergic neural progenitor cell injection) in patients with Parkinson's disease.
Trial Details
NCT Number NCT07080775
Lead Sponsor XellSmart Therapeutics (Shanghai) Co., Ltd.
Collaborators: Beijing Tiantan Hospital
Conditions
(from sponsor)		 Parkinson's Disease
Related terms Parkinson Disease
Enrollment 39 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov