Clinical trial NCT02352077: NeuroRegen Scaffold™ With Stem Cells for Chronic Spinal Cord Injury Repair
Official title: Safety and Efficacy of NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells or Mesenchymal Stem Cells for Chronic Spinal Cord Injury Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Spinal Cord Injury
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: Affiliated Hospital of Logistics University of CAPF
name: The First Affiliated Hospital of Soochow University
name: First Hospitals affiliated to the China PLA General Hospital
First posted: 2015-02-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of NeuroRegen scaffold with bone marrow mononuclear cells (BMMCs) or mesenchymal stem cells (MSCs) in patients with chronic 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: Safety Evaluation Number of patients with adverse events
timeFrame: 6 months
Secondary outcomes:
measure: Improvements in Neurophysiological Measures omatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed
timeFrame: 12 months
measure: Improvements in ASIA Impairment Scale
timeFrame: 12 months
measure: Improvements in Independence Measures and Quality of Life
timeFrame: 12 months
measure: Improvements in Pain assessed based on Visual analog scale (VAS)
timeFrame: 12 months
measure: Improvements in Urinary and Bowel Function assessed based on bladder pressure monitory before and after transplantation
timeFrame: 12 months
measure: Changes at the Transplantation Site in Spinal Cord by Magnetic Resonance Imaging (MRI)
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: First Hospitals affiliated to the China PLA General Hospital
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
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
affiliation: Affiliated Hospital of Logistics Universtiy of CAPF
name: Sai Zhang, M.D
role: STUDY_CHAIR
affiliation: The First Affiliated Hospital of Soochow University
name: Huilin Yang, Ph.D
role: STUDY_CHAIR
affiliation: First Hospitals affiliated to the China PLA General Hospital
name: Shuxun Hou
role: STUDY_CHAIR
References: