Functional Scaffold Transplantation Combined With Epidural Electrical Stimulation for Spinal Cord Injury Repair

Phase 1

• Conditions: Spinal Cord Injury
• Interventions: Device: Epidural Electrical Stimulation; Combination Product: Functional scaffold & Epidural Electrical Stimulation

• Registration Number: NCT03966794
• Lead Sponsor: Chinese Academy of Sciences

Brief Summary

The study is designed to assess the role of functional neural regeneration collagen scaffold transplantation combined with epidural electrical stimulation in spinal cord injury patients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-05-28
• Study First Posted: 2019-05-29
• Study Start: 2019-08-01
• Last Update Submitted: 2019-10-31
• Last Update Posted: 2019-11-01
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

The enrolled participants are divided into three categories:

1. Participants had complete functional scaffold transplantation in previous study and had motor functional recovery
2. Participants With Acute Complete SCI: (1) Classification ASIA A, occurring within past 14 days; (2) Completely spinal cord injury at neurological level C4- T12/L1; (3) No serious complications
3. Participants With Chronic Complete SCI: (1) Classification ASIA A, greater than 6 months post injury and no significant further improvement within past 3 months; (2) Completely spinal cord injury at neurological level C4- T12/L1; (3) Peripheral nervous system in good condition; (4) No serious complications

Inclusion Criteria For All The Participants

1. Men or non-pregnant women, 18-60 years old
2. Ability and willingness to regular visit to hospital and follow up during the protocol Procedures
3. Accompanied by a family member
4. Signed informed consent

Exclusion Criteria

1. Obvious muscle atrophy or fibrosis
2. Decline in peripheral nerve function
3. A current diagnosis of diseases affecting spinal cord injury recovery or rehabilitation training (e.g., brain injury, cerebral hemorrhage, cognitive impairment, other central nervous system diseases)
4. Having serious health problems, (e.g., cardiovascular disease, diabetes, autoimmune diseases, tumors or severe hypertension) or serious complications (e.g. severe bedsores, pulmonary infection, respiratory disorders)
5. Pregnancy or lactation
6. History of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders
7. No family member accompany or can not get in touch with family members
8. Poor compliance, difficult to complete the study
9. Any other conditions that might increase the risk of participants or interfere with the clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural Electrical Stimulation	Epidural Electrical Stimulation	-
Functional scaffold & Epidural Electrical Stimulation	Functional scaffold & Epidural Electrical Stimulation	-

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability assessed by Adverse Events	Up to 6 months	Proportion of patients with postoperative infections and serious adverse events (SAEs) will be assessed by long term follow-up
Change in ASIA Impairment Scale	Baseline, 1, 3 , 6, 12 and 24 months post-treatment	American Spinal Injury Association Impairment Scale of A, B, C, D or E will be assessed before and after transplantation.

Secondary Outcome Measures

Name	Time	Method
Change in ASIA motor score	Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Change in Functional Independence Measure (FIM)	Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Change in Walking Speed	Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Change in Somatosensory Evoked Potentials (SSEP) monitoring	Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Change in Motor Evoked Potentials (MEP) monitoring	Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Changes at the Transplantation Site in Spinal Cord by Magnetic Resonance Imaging (MRI)	Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Change in Stride length	Baseline, 1, 3 , 6, 12 and 24 months post-treatment

Trial Locations

Locations (1)

Affiliated Hospital of Logistics Universtiy of CAPF; 🇨🇳 Tianjin, China