Functional Scaffold Transplantation Combined With Epidural Electrical Stimulation for Spinal Cord Injury Repair
NCT ID: NCT03966794
Last Updated: 2019-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
9 participants
INTERVENTIONAL
2019-08-01
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Epidural Electrical Stimulation
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.
Functional scaffold & Epidural Electrical Stimulation
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
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
18 Years
60 Years
ALL
No
Sponsors
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Affiliated Hospital of Logistics University of CAPF
OTHER
Chinese Academy of Sciences
OTHER_GOV
Responsible Party
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Jianwu Dai
Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS
Principal Investigators
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Jianwu Dai, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Sciences
Locations
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Affiliated Hospital of Logistics Universtiy of CAPF
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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Fengwu Tang
Role: primary
Other Identifiers
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CAS-XDA-EESCI/IGDB
Identifier Type: -
Identifier Source: org_study_id
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