Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03966794
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
Affiliated Hospital of Logistics University of CAPF
Information provided by (Responsible Party):
Jianwu Dai, Chinese Academy of Sciences

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

Layout table for study information
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
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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.




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03966794


Contacts
Layout table for location contacts
Contact: Guang Han 86-22-60577133 hanguang2006@126.com

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Jianwu Dai, Ph.D Chinese Academy of Sciences

Layout table for additonal information
Responsible Party: Jianwu Dai, Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT03966794     History of Changes
Other Study ID Numbers: CAS-XDA-EESCI/IGDB
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System