Clinical trial NCT02688049: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Spinal Cord Injury
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: Affiliated Hospital of Logistics University of CAPF
First posted: 2016-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Male or female, 18-65 years old.
2. Completely spinal cord injury at the cervical and thoracic level (C5-T12).
3. Classification ASIA A with no significant further improvement.
4. Patients signed informed consent.
5. Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.

Exclusion Criteria:

1. 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).
2. Serious complications (e.g., hydronephrosis due to renal insufficiency, severe bedsores (Ⅲ° above), lower extremity venous thrombosis, severe myositis ossificans).
3. History of life threatening allergic or immune-mediated reaction.
4. Clinically significant abnormalities in routine laboratory examinations (hematology, electrolytes, biochemistry, liver and kidney function tests, urinanalysis).
5. History of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders.
6. 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.
7. Lactating and pregnant woman.
8. Alcohol drug abuse /dependence.
9. Participated in any other clinical trials within 3 months before the enrollment.
10. A drug or treatment known to cause effect on the central nervous system during the past four weeks.
11. A drug or treatment known to cause major organ system toxicity during the past four weeks.
12. Poor compliance, difficult to complete the study.
13. Any other conditions that might increase the risk of subjects or interfere with the clinical trial.

Primary outcomes:
measure: Improvements in ASIA (American Spinal Injury Association) Impairment Scale
timeFrame: 24 months
measure: Improvements in Somatosensory Evoked Potentials (SSEP)
timeFrame: 24 months
measure: Improvements in Motor Evoked Potentials (MEP)
timeFrame: 24 months
Secondary outcomes:
measure: Improvements in Independence Measures
timeFrame: 1, 3, 6, 12, 18 and 24 months
measure: Changes at the transplantation site in spinal cord by Magnetic Resonance Imaging (MRI)
timeFrame: 1, 3, 6, 12, 18 and 24 months
measure: Improvements in Urinary and Bowel Function
timeFrame: 1, 3, 6, 12, 18 and 24 months
measure: Safety and Tolerability assessed by Adverse Events
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Affiliated Hospital of Logistics Universtiy of CAPF
Study officials:
affiliation: Chinese Academy of Sciences
name: Jianwu Dai, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: