Human dental follicle stem cells for subacute spinal cord injury: a phase I clinical study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200064332

Enrollment

Unknown

Registered

2022-10-02

Start date

2022-10-01

Completion date

Unknown

Last updated

2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

Interventions

Control group:No intervening measure

Group 1:Subarachnoid injection of human DFSCs .Injection dose: 1× 10^6pcs/Kg/time, number of injections: 1 time

Group 2:Subarachnoid injection of human DFSCs .Injection dose: 5× 10^6pcs/Kg/time, number of injections: 1 time

Group 3:Subarachnoid injection of human DFSCs .Injection dose: 1× 10^7pcs/Kg/time, number of injections: 1 time

Group 4:Subarachnoid injection of human DFSCs .Injection dose: 5× 10^6pcs/Kg/time, number of injections: 2 times

Group 5:Subarachnoid injection of human DFSCs .Injection dose: 1× 10^7pcs/Kg/time, number of injections: 2 times

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 60 years old 2. Spinal cord injury caused by fallen, traffic accidents, crushing, et al.; 3. Already had spinal surgery; 4. ASIA impairment scale: Grade A, Grade B, and Grade C; 5. Single-site spinal cord injury; 6. Course of disease: between 2 weeks and 2 months; 7. No dural defect; 8. Willing to complete the follow-ups.

Exclusion criteria

Exclusion criteria: 1. Non-traumatic spinal cord injury; 2. Damage of endorhachis; 3. Multiple-site spinal cord injury; 4. CSF signal was disrupted on MRI; 5. On mechanical ventilation; 6. With cancer; 7. With other nervous system diesease(s); 8. With coagulation disorders; 9. With hypohepatia; 10. With renal dysfunction; 11. With active infection or uncontrolled infection; 12. HIV-positive; 13. HCV-positive; 14. HBV-positive; 15. TP-positive; 16. BMI>35; 17. Pregnancy; 18. With mental disorders; 19. Received previous stem cells treatment; 20. In the clinical study of other projects; 21. Could not complete the follow-up; 22. With other condition which may be not suitable for this study.

Design outcomes

Primary

Measure	Time frame
ASIA classification;ASIA score;IANR-SCIRFS score;	—

Secondary

Measure	Time frame
Neurophysiology monitoring;Ashworth muscle tone scale;MRI-DTI;Urodynamic study;	—

Countries

China

Contacts

Public ContactHao Liu

West China Hospital, Sichuan University

liuhao6304@163.com+86 18980601369

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026