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

Spinal Cord Injury Clinical Trial

Official title:

The Efficacy and Safety of NeuroRegen Scaffold™ Combined With Mesenchymal Stem Cells or Neural Stem Cells for Chronic Spinal Cord Injury Repair

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02688049
• Other study ID #: CAS-XDA-MNSCI/IGDB
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• Start date: January 2016
• Est. completion date: December 2021

Study information

• Verified date: February 2016
• Source: Chinese Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Biological:
• NeuroRegen scaffold/mesenchymal stem cells transplantation
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.
• NeuroRegen scaffold/neural stem cells transplantation
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.

Locations

Country	Name	City	State
China	Affiliated Hospital of Logistics Universtiy of CAPF	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Sciences	Affiliated Hospital of Logistics University of CAPF

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvements in ASIA (American Spinal Injury Association) Impairment Scale		24 months
Primary	Improvements in Somatosensory Evoked Potentials (SSEP)		24 months
Primary	Improvements in Motor Evoked Potentials (MEP)		24 months
Secondary	Improvements in Independence Measures	Functional Independence Measure (FIM) will be assessed before and after surgery.	1, 3, 6, 12, 18 and 24 months
Secondary	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.	1, 3, 6, 12, 18 and 24 months
Secondary	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.	1, 3, 6, 12, 18 and 24 months
Secondary	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.	Up to 6 months