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

Spinal Cord Injury Clinical Trial

Official title:

Safety and Efficacy of Functional Neural Regeneration Collagen Scaffold Transplantation Combined With Epidural Electrical Stimulation for Spinal Cord Injury Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03966794
• Other study ID #: CAS-XDA-EESCI/IGDB
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 1, 2019
• Est. completion date: December 2021

Study information

• Verified date: May 2019
• Source: Chinese Academy of Sciences
• Contact: Guang Han
• Phone: 86-22-60577133
• Email: hanguang2006[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Device:
• Epidural Electrical Stimulation
Participants had finished the previous clinical trial with functional neural regeneration collagen scaffold transplantation, and will receive epidural electrical stimulation of the spinal cord in this group.

Combination Product:
• Functional scaffold & Epidural Electrical Stimulation
Participants with acute complete SCI or chronic complete SCI will receive functional neural regeneration scaffold transplantation and epidural electrical stimulation of the spinal cord.

Locations

Country	Name	City	State
China	Affiliated Hospital of Logistics Universtiy of CAPF	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Sciences	Affiliated Hospital of Logistics University of CAPF

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability assessed by Adverse Events	Proportion of patients with postoperative infections and serious adverse events (SAEs) will be assessed by long term follow-up	Up to 6 months
Primary	Change in ASIA Impairment Scale	American Spinal Injury Association Impairment Scale of A, B, C, D or E will be assessed before and after transplantation.	Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Secondary	Change in ASIA motor score		Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Secondary	Change in Functional Independence Measure (FIM)		Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Secondary	Change in Somatosensory Evoked Potentials (SSEP) monitoring		Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Secondary	Change in Motor Evoked Potentials (MEP) monitoring		Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Secondary	Changes at the Transplantation Site in Spinal Cord by Magnetic Resonance Imaging (MRI)		Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Secondary	Change in Walking Speed		Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Secondary	Change in Stride length		Baseline, 1, 3 , 6, 12 and 24 months post-treatment