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

Primary Purpose

Spinal Cord Injury

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Epidural Electrical Stimulation
Functional scaffold & Epidural Electrical Stimulation
Sponsored by
Chinese Academy of Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Affiliated Hospital of Logistics Universtiy of CAPFRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Epidural Electrical Stimulation

Functional scaffold & Epidural Electrical Stimulation

Arm Description

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Change in ASIA motor score
Change in Functional Independence Measure (FIM)
Change in Somatosensory Evoked Potentials (SSEP) monitoring
Change in Motor Evoked Potentials (MEP) monitoring
Changes at the Transplantation Site in Spinal Cord by Magnetic Resonance Imaging (MRI)
Change in Walking Speed
Change in Stride length

Full Information

First Posted
May 23, 2019
Last Updated
October 31, 2019
Sponsor
Chinese Academy of Sciences
Collaborators
Affiliated Hospital of Logistics University of CAPF
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1. Study Identification

Unique Protocol Identification Number
NCT03966794
Brief Title
Functional Scaffold Transplantation Combined With Epidural Electrical Stimulation for Spinal Cord Injury Repair
Official Title
Safety and Efficacy of Functional Neural Regeneration Collagen Scaffold Transplantation Combined With Epidural Electrical Stimulation for Spinal Cord Injury Repair
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Sciences
Collaborators
Affiliated Hospital of Logistics University of CAPF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epidural Electrical Stimulation
Arm Type
Experimental
Arm Title
Functional scaffold & Epidural Electrical Stimulation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Epidural Electrical Stimulation
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Functional scaffold & Epidural Electrical Stimulation
Intervention Description
Participants with acute complete SCI or chronic complete SCI will receive functional neural regeneration scaffold transplantation and epidural electrical stimulation of the spinal cord.
Primary Outcome Measure Information:
Title
Safety and Tolerability assessed by Adverse Events
Description
Proportion of patients with postoperative infections and serious adverse events (SAEs) will be assessed by long term follow-up
Time Frame
Up to 6 months
Title
Change in ASIA Impairment Scale
Description
American Spinal Injury Association Impairment Scale of A, B, C, D or E will be assessed before and after transplantation.
Time Frame
Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Secondary Outcome Measure Information:
Title
Change in ASIA motor score
Time Frame
Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Title
Change in Functional Independence Measure (FIM)
Time Frame
Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Title
Change in Somatosensory Evoked Potentials (SSEP) monitoring
Time Frame
Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Title
Change in Motor Evoked Potentials (MEP) monitoring
Time Frame
Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Title
Changes at the Transplantation Site in Spinal Cord by Magnetic Resonance Imaging (MRI)
Time Frame
Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Title
Change in Walking Speed
Time Frame
Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Title
Change in Stride length
Time Frame
Baseline, 1, 3 , 6, 12 and 24 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Inclusion Criteria For All The Participants 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guang Han
Phone
86-22-60577133
Email
hanguang2006@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianwu Dai, Ph.D
Organizational Affiliation
Chinese Academy of Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital of Logistics Universtiy of CAPF
City
Tianjin
ZIP/Postal Code
300162
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fengwu Tang
First Name & Middle Initial & Last Name & Degree
Shixiang Cheng
Email
shixiangcheng@vip.126.com

12. IPD Sharing Statement

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

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