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出境医 / 临床实验 / Functional Scaffold Transplantation Combined With Epidural Electrical Stimulation for Spinal Cord Injury Repair

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

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: Epidural Electrical Stimulation Combination Product: Functional scaffold & Epidural Electrical Stimulation Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Functional Neural Regeneration Collagen Scaffold Transplantation Combined With Epidural Electrical Stimulation for Spinal Cord Injury Repair
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Epidural Electrical Stimulation 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.
Experimental: Functional scaffold & Epidural Electrical Stimulation 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.
Outcome Measures
Primary Outcome Measures :
  1. Safety and Tolerability assessed by Adverse Events [ Time Frame: Up to 6 months ]
    Proportion of patients with postoperative infections and serious adverse events (SAEs) will be assessed by long term follow-up

  2. Change in ASIA Impairment Scale [ Time Frame: 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 :
  1. Change in ASIA motor score [ Time Frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment ]
  2. Change in Functional Independence Measure (FIM) [ Time Frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment ]
  3. Change in Somatosensory Evoked Potentials (SSEP) monitoring [ Time Frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment ]
  4. Change in Motor Evoked Potentials (MEP) monitoring [ Time Frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment ]
  5. 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 ]
  6. Change in Walking Speed [ Time Frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment ]
  7. Change in Stride length [ Time Frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
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Contact: Guang Han 86-22-60577133 hanguang2006@126.com

Locations
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China
Affiliated Hospital of Logistics Universtiy of CAPF Recruiting
Tianjin, China, 300162
Contact: Fengwu Tang         
Contact: Shixiang Cheng       shixiangcheng@vip.126.com   
Sponsors and Collaborators
Chinese Academy of Sciences
Affiliated Hospital of Logistics University of CAPF
Investigators
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Principal Investigator: Jianwu Dai, Ph.D Chinese Academy of Sciences
Tracking Information
First Submitted Date  ICMJE May 23, 2019
First Posted Date  ICMJE May 29, 2019
Last Update Posted Date November 1, 2019
Actual Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
  • Safety and Tolerability assessed by Adverse Events [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
  • Change in ASIA motor score [ Time Frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment ]
  • Change in Functional Independence Measure (FIM) [ Time Frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment ]
  • Change in Somatosensory Evoked Potentials (SSEP) monitoring [ Time Frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment ]
  • Change in Motor Evoked Potentials (MEP) monitoring [ Time Frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment ]
  • 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 ]
  • Change in Walking Speed [ Time Frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment ]
  • Change in Stride length [ Time Frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Functional Scaffold Transplantation Combined With Epidural Electrical Stimulation for Spinal Cord Injury Repair
Official Title  ICMJE Safety and Efficacy of Functional Neural Regeneration Collagen Scaffold Transplantation Combined With Epidural Electrical Stimulation for Spinal Cord Injury Repair
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Epidural Electrical Stimulation
    Intervention: Device: Epidural Electrical Stimulation
  • Experimental: Functional scaffold & Epidural Electrical Stimulation
    Intervention: Combination Product: Functional scaffold & Epidural Electrical Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 28, 2019) 		9
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Guang Han 86-22-60577133 hanguang2006@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03966794
Other Study ID Numbers  ICMJE CAS-XDA-EESCI/IGDB
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jianwu Dai, Chinese Academy of Sciences
Study Sponsor  ICMJE Chinese Academy of Sciences
Collaborators  ICMJE Affiliated Hospital of Logistics University of CAPF
Investigators  ICMJE
Principal Investigator: Jianwu Dai, Ph.D Chinese Academy of Sciences
PRS Account Chinese Academy of Sciences
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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