Exploratory Clinical Research with AT-06 for Chronic Spinal Cord Injury

Phase 2

Recruiting

• Conditions: Chronic Spinal Cord Injury

• Registration Number: JPRN-jRCTs032230232
• Lead Sponsor: Suda Kota

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-14
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Patients 16 years of age or older at the time of consent.
2. Patients who are at least 6 months post-injury.
3. Patients with a modified Frankel classification of A, B, or C.
4. Patients who have given written consent to participate in the study of their own free will (however, patients who have difficulty in writing may write on their own behalf, and for minors, the consent of the patient and his/her surrogate should be obtained).

Exclusion Criteria

1. Patients with impaired consciousness
2. Patients with neurological, cerebrovascular, or musculoskeletal disease that may affect the evaluation of neurological symptoms
3. Patients diagnosed with malignant tumor
4. Patients whose symptoms are expected to deteriorate rapidly during the treatment period
5. Patients with dementia or psychiatric disorders
6. Patients with multiple traumatic injuries or organ damage and unstable general condition
7. Patients with fractures of the extremities, spine, or other parts of the body that may affect the evaluation
8. Patients using life-supporting medical electrical equipment such as artificial heart lungs and pacemakers
9. Patients using medical electrical equipment such as electrocardiographs or other wearable medical devices
10. Patients with a history of substance abuse (e.g., alcohol)
11. Patients who are participating or have participated within 12 weeks prior to obtaining consent in clinical trials of other drugs or medical devices

Study & Design

• Study Type: Interventional
• Study Design: Not specified