Safety and Preliminary Efficacy of NXL-001 in Patients with Ischemic Stroke
NCT06761183 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2025-01-07
Summary
This is a single-arm, open-label, single center, dose-escalation exploratory clinical study to evaluate the safety and tolerability of a single intracerebral injection of NXL-001, a NeuroD1 base gene therapy, in patients with chronic neuronal deficits from ischemic stroke.
Conditions
Interventions
- GENETIC
-
intracerebral stereotactic injection of NXL-001
intracerebral stereotactic injection of NXL-001: with 3 subjects in each group to receive a single stereo-tactically intracerebral injection of NXL-001 at escalating doses.
Sponsors & Collaborators
-
Beijing Tiantan Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 40 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-31
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- China
Study Locations
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