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

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

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.

Study Overview

• Status: Unknown
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Biological: NeuroRegen scaffold with BMMCs or MSCs transplantation

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100037
    • First Hospitals affiliated to the China PLA General Hospital
  • Suzhou, China, 215006
    • The First Affiliated Hospital of Soochow University
  • Tianjin, China, 300162
    • Affiliated Hospital of Logistics Universtiy of CAPF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NeuroRegen Scaffold with BMMCs or MSCs transplantation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Chinese Academy of Sciences
• Collaborators: The First Affiliated Hospital of Soochow University; First Hospitals affiliated to the China PLA General Hospital; Affiliated Hospital of Logistics University of CAPF

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: January 20, 2015
• First Submitted That Met QC Criteria: January 30, 2015
• First Posted (Estimate): February 2, 2015

Study Record Updates

• Last Update Posted (Actual): December 23, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: CAS-XDA-SCI/IGDB