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

Spinal Cord Injury Clinical Trial

Official title:

Safety and Efficacy of NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells or Mesenchymal Stem Cells for Chronic Spinal Cord Injury Repair

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02352077
• Other study ID #: CAS-XDA-SCI/IGDB
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: January 2015
• Est. completion date: December 2021

Study information

• Verified date: October 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 safety and efficacy of NeuroRegen scaffold with bone marrow mononuclear cells (BMMCs) or mesenchymal stem cells (MSCs) in patients with chronic 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 with BMMCs or MSCs transplantation
Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) or mesenchymal stem cells (MSCs) transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.

Locations

Country	Name	City	State
China	First Hospitals affiliated to the China PLA General Hospital	Beijing
China	The First Affiliated Hospital of Soochow University	Suzhou
China	Affiliated Hospital of Logistics Universtiy of CAPF	Tianjin

Sponsors (4)

Lead Sponsor	Collaborator
Chinese Academy of Sciences	Affiliated Hospital of Logistics University of CAPF, First Hospitals affiliated to the China PLA General Hospital, The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Evaluation Number of patients with adverse events	Number of patients with adverse events is as a measure of safety and tolerability after collagen scaffold with MSCs transplantation.	6 months
Secondary	Improvements in Neurophysiological Measures omatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed	Somatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed before and after transplantation.	12 months
Secondary	Improvements in ASIA Impairment Scale	American Spinal Injury Assessment Scale of A, B, C, D or E will be assessed before and after transplantation.	12 months
Secondary	Improvements in Independence Measures and Quality of Life	Functional Independence Measure (FIM) and the Quality of Life Questionnaire (EQ 5D) will be assessed before and after transplantation.	12 months
Secondary	Improvements in Pain assessed based on Visual analog scale (VAS)	Pain intensity will be assessed based on Visual analog scale (VAS) before and after transplantation.	12 months
Secondary	Improvements in Urinary and Bowel Function assessed based on bladder pressure monitory before and after transplantation	The ability to feel and control urination and bowel will be assessed based on bladder pressure monitory before and after transplantation.	12 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.	12 months