NeuroRegen Scaffold™ Combined With Stem Cells for Chronic Spinal Cord Injury Repair

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02688049
• Date of registration: 06/02/2016
• Prospective Registration: No
• Primary sponsor: Chinese Academy of Sciences
• Public title: NeuroRegen Scaffold™ Combined With Stem Cells for Chronic Spinal Cord Injury Repair
• Scientific title: The Efficacy and Safety of NeuroRegen Scaffold™ Combined With Mesenchymal Stem Cells or Neural Stem Cells for Chronic Spinal Cord Injury Repair
• Date of first enrolment: January 2016
• Target sample size: 30
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT02688049
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

China

Contacts

• Name: Jianwu Dai, Ph.D
• Affiliation: Chinese Academy of Sciences

Key inclusion & exclusion 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 (?° 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Spinal Cord Injury

Intervention(s)

Biological: NeuroRegen scaffold/mesenchymal stem cells transplantation

Biological: NeuroRegen scaffold/neural stem cells transplantation

Primary Outcome(s)

Improvements in Motor Evoked Potentials (MEP) [Time Frame: 24 months]

Improvements in ASIA (American Spinal Injury Association) Impairment Scale [Time Frame: 24 months]

Improvements in Somatosensory Evoked Potentials (SSEP) [Time Frame: 24 months]

Secondary Outcome(s)

Improvements in Independence Measures [Time Frame: 1, 3, 6, 12, 18 and 24 months]

Safety and Tolerability assessed by Adverse Events [Time Frame: Up to 6 months]

Improvements in Urinary and Bowel Function [Time Frame: 1, 3, 6, 12, 18 and 24 months]

Changes at the transplantation site in spinal cord by Magnetic Resonance Imaging (MRI) [Time Frame: 1, 3, 6, 12, 18 and 24 months]

Secondary ID(s)

CAS-XDA-MNSCI/IGDB

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Affiliated Hospital of Logistics University of CAPF