RecruitingSpinal Cord InjuryChronic Spinal Cord Injury

First-in-Human Clinical Trial of STUP-001, an In Vivo Direct Cell Conversion Gene Therapy for AIS-A/B Chronic Spinal Cord Injury

Eligible age

19–60 yrs

Accepts

All genders

Locations

0 states

Healthy volunteers

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This study aim to investigate the safety and exploratory efficacy of STUP-001 which is AAV-based spinal cord injury investigational product.

Sponsor: Yonsei University

✓ Male and female adults aged 19 to 60 years at the time of obtaining informed consent.
✓ Patients diagnosed with traumatic spinal cord injury classified as ASIA Impairment Scale (AIS) grade A or B:
✓ 1. AIS-A: Complete loss of sensory and motor function.
✓ 2. AIS-B: Partial preservation of sensory function with complete motor paralysis
✓ Patients who have been diagnosed with traumatic spinal cord injury for at least 6 months at the time of screening.
✓ At the time of screening, women must provide evidence of non-fertile status by meeting at least one of the following criteria:
✓ (a) Postmenopausal women: Defined as women over the age of 50 who have been amenorrheic for at least 12 consecutive months after discontinuing all exogenous hormonal treatments.
✓ (b) Women with irreversible surgical infertility, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. (Tubal ligation is not accepted.) (c) Women 50 years or younger who have been amenorrheic for at least 12 consecutive months after discontinuing all exogenous hormonal treatments and have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels within the postmenopausal range defined by the study site.

✕ Patients diagnosed with traumatic spinal cord injury (SCI) classified as AIS-C or D at the time of screening.
✕ Patients with the following cardiovascular conditions at the time of screening:
✕ 1. Myocardial infarction or unstable angina within the past 6 months.
✕ 2. QTc interval ≥ 450 msec or clinically significant electrocardiographic (ECG) abnormalities.
✕ 3. Congestive heart failure (CHF) classified as New York Heart Association (NYHA) Class II or higher.
✕ 4. Stroke or transient ischemic attack (TIA) within the past 6 months.
✕ Patients with uncontrolled diabetes mellitus (e.g., HbA1c \> 8% at screening).
✕ Patients with uncontrolled hypertension (e.g., systolic BP \> 180 mmHg or diastolic BP \> 100 mmHg).

Source: ClinicalTrials.gov · NCT06922890 · last updated 2025-07-16