Functional Scaffold Transplantation Combined With Epidural Electrical Stimulation for Spinal Cord Injury Repair
Safety and Efficacy of Functional Neural Regeneration Collagen Scaffold Transplantation Combined With Epidural Electrical Stimulation for Spinal Cord Injury Repair
1 other identifier
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2019
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2019
CompletedFirst Posted
Study publicly available on registry
May 29, 2019
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedNovember 1, 2019
May 1, 2019
2.3 years
May 23, 2019
October 31, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (7)
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 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
- +2 more secondary outcomes
Study Arms (2)
Epidural Electrical Stimulation
EXPERIMENTALFunctional scaffold & Epidural Electrical Stimulation
EXPERIMENTALInterventions
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.
Participants with acute complete SCI or chronic complete SCI will receive functional neural regeneration scaffold transplantation and epidural electrical stimulation of the spinal cord.
Eligibility Criteria
You may qualify if:
- The enrolled participants are divided into three categories:
- Participants had complete functional scaffold transplantation in previous study and had motor functional recovery
- 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
- 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
- Men or non-pregnant women, 18-60 years old
- Ability and willingness to regular visit to hospital and follow up during the protocol Procedures
- Accompanied by a family member
- Signed informed consent
You may not qualify if:
- Obvious muscle atrophy or fibrosis
- Decline in peripheral nerve function
- 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)
- 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)
- Pregnancy or lactation
- History of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders
- No family member accompany or can not get in touch with family members
- Poor compliance, difficult to complete the study
- Any other conditions that might increase the risk of participants or interfere with the clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Affiliated Hospital of Logistics Universtiy of CAPF
Tianjin, 300162, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianwu Dai, Ph.D
Chinese Academy of Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS
Study Record Dates
First Submitted
May 23, 2019
First Posted
May 29, 2019
Study Start
August 1, 2019
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
November 1, 2019
Record last verified: 2019-05