Back to resultsNeuroRegen Scaffold™ Combined With Stem Cells for Chronic Spinal Cord Injury Repair
Primary Purpose
Spinal Cord Injury
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
NeuroRegen scaffold/mesenchymal stem cells transplantation
NeuroRegen scaffold/neural stem cells transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury
Eligibility Criteria
Inclusion Criteria:
- Male or female, 18-65 years old.
- Completely spinal cord injury at the cervical and thoracic level (C5-T12).
- Classification ASIA A with no significant further improvement.
- Patients signed informed consent.
- Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.
Exclusion Criteria:
- A current diagnosis of any primary diseases affecting limb functions (e.g., trauma, infection, tumors, congenital malformations, peripheral muscular dystrophy, Huntington's disease, Parkinson's disease).
- Serious complications (e.g., hydronephrosis due to renal insufficiency, severe bedsores (Ⅲ° above), lower extremity venous thrombosis, severe myositis ossificans).
- History of life threatening allergic or immune-mediated reaction.
- Clinically significant abnormalities in routine laboratory examinations (hematology, electrolytes, biochemistry, liver and kidney function tests, urinanalysis).
- History of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders.
- Severe arrhythmias (e.g., ventricular tachycardia, frequent superventricular tachycardia, atrial fibrillation, and atrial flutter) or cardiac degree II or above conduction abnormalities displayed via 12-lead ECG.
- Lactating and pregnant woman.
- Alcohol drug abuse /dependence.
- Participated in any other clinical trials within 3 months before the enrollment.
- A drug or treatment known to cause effect on the central nervous system during the past four weeks.
- A drug or treatment known to cause major organ system toxicity during the past four weeks.
- Poor compliance, difficult to complete the study.
- Any other conditions that might increase the risk of subjects or interfere with the clinical trial.
Sites / Locations
- Affiliated Hospital of Logistics Universtiy of CAPF
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
NeuroRegen scaffold/mesenchymal stem cells transplantation
NeuroRegen scaffold/neural stem cells transplantation
Arm Description
Patients receive NeuroRegen scaffold with mesenchymal stem cells transplantation after spinal cord injury.
Patients receive NeuroRegen scaffold with neural stem cells transplantation after spinal cord injury.
Outcomes
Primary Outcome Measures
Improvements in ASIA (American Spinal Injury Association) Impairment Scale
Improvements in Somatosensory Evoked Potentials (SSEP)
Improvements in Motor Evoked Potentials (MEP)
Secondary Outcome Measures
Improvements in Independence Measures
Functional Independence Measure (FIM) will be assessed before and after surgery.
Changes at the transplantation site in spinal cord by Magnetic Resonance Imaging (MRI)
The MRI at the transplantation site will be assessed before and after transplantation.
Improvements in Urinary and Bowel Function
The ability to feel and control urination and bowel will be assessed based on bladder pressure monitory before and after surgery.
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.
Full Information
NCT ID
NCT02688049
First Posted
February 6, 2016
Last Updated
December 21, 2020
Sponsor
Chinese Academy of Sciences
Collaborators
Affiliated Hospital of Logistics University of CAPF
1. Study Identification
Unique Protocol Identification Number
NCT02688049
Brief Title
NeuroRegen Scaffold™ Combined With Stem Cells for Chronic Spinal Cord Injury Repair
Official Title
The Efficacy and Safety of NeuroRegen Scaffold™ Combined With Mesenchymal Stem Cells or Neural Stem Cells for Chronic Spinal Cord Injury Repair
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy and safety of mesenchymal stem cells or neural stem cells combined with NeuroRegen scaffold transplantation in patients with spinal cord injury.
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NeuroRegen scaffold/mesenchymal stem cells transplantation
Arm Type
Experimental
Arm Description
Patients receive NeuroRegen scaffold with mesenchymal stem cells transplantation after spinal cord injury.
Arm Title
NeuroRegen scaffold/neural stem cells transplantation
Arm Type
Experimental
Arm Description
Patients receive NeuroRegen scaffold with neural stem cells transplantation after spinal cord injury.
Intervention Type
Biological
Intervention Name(s)
NeuroRegen scaffold/mesenchymal stem cells transplantation
Intervention Description
Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with 10 million mesenchymal stem cells transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
Intervention Type
Biological
Intervention Name(s)
NeuroRegen scaffold/neural stem cells transplantation
Intervention Description
Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with 10 million neural stem cells transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
Primary Outcome Measure Information:
Title
Improvements in ASIA (American Spinal Injury Association) Impairment Scale
Time Frame
24 months
Title
Improvements in Somatosensory Evoked Potentials (SSEP)
Time Frame
24 months
Title
Improvements in Motor Evoked Potentials (MEP)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Improvements in Independence Measures
Description
Functional Independence Measure (FIM) will be assessed before and after surgery.
Time Frame
1, 3, 6, 12, 18 and 24 months
Title
Changes at the transplantation site in spinal cord by Magnetic Resonance Imaging (MRI)
Description
The MRI at the transplantation site will be assessed before and after transplantation.
Time Frame
1, 3, 6, 12, 18 and 24 months
Title
Improvements in Urinary and Bowel Function
Description
The ability to feel and control urination and bowel will be assessed based on bladder pressure monitory before and after surgery.
Time Frame
1, 3, 6, 12, 18 and 24 months
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, 18-65 years old.
Completely spinal cord injury at the cervical and thoracic level (C5-T12).
Classification ASIA A with no significant further improvement.
Patients signed informed consent.
Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.
Exclusion Criteria:
A current diagnosis of any primary diseases affecting limb functions (e.g., trauma, infection, tumors, congenital malformations, peripheral muscular dystrophy, Huntington's disease, Parkinson's disease).
Serious complications (e.g., hydronephrosis due to renal insufficiency, severe bedsores (Ⅲ° above), lower extremity venous thrombosis, severe myositis ossificans).
History of life threatening allergic or immune-mediated reaction.
Clinically significant abnormalities in routine laboratory examinations (hematology, electrolytes, biochemistry, liver and kidney function tests, urinanalysis).
History of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders.
Severe arrhythmias (e.g., ventricular tachycardia, frequent superventricular tachycardia, atrial fibrillation, and atrial flutter) or cardiac degree II or above conduction abnormalities displayed via 12-lead ECG.
Lactating and pregnant woman.
Alcohol drug abuse /dependence.
Participated in any other clinical trials within 3 months before the enrollment.
A drug or treatment known to cause effect on the central nervous system during the past four weeks.
A drug or treatment known to cause major organ system toxicity during the past four weeks.
Poor compliance, difficult to complete the study.
Any other conditions that might increase the risk of subjects or interfere with the clinical trial.
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
12. IPD Sharing Statement
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NeuroRegen Scaffold™ Combined With Stem Cells for Chronic Spinal Cord Injury Repair
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