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

NCT02688049 | Unknown Phase 1

• 1 other identifier: CAS-XDA-MNSCI/IGDB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (3)

• Improvements in ASIA (American Spinal Injury Association) Impairment Scale

  24 months

• Improvements in Somatosensory Evoked Potentials (SSEP)

  24 months

• Improvements in Motor Evoked Potentials (MEP)

  24 months

Secondary Outcomes (4)

• Improvements in Independence Measures

  1, 3, 6, 12, 18 and 24 months

• Changes at the transplantation site in spinal cord by Magnetic Resonance Imaging (MRI)

  1, 3, 6, 12, 18 and 24 months

• Improvements in Urinary and Bowel Function

  1, 3, 6, 12, 18 and 24 months

• Safety and Tolerability assessed by Adverse Events

  Up to 6 months

Study Arms (2)

NeuroRegen scaffold/mesenchymal stem cells transplantation

EXPERIMENTAL

Patients receive NeuroRegen scaffold with mesenchymal stem cells transplantation after spinal cord injury.

Biological: NeuroRegen scaffold/mesenchymal stem cells transplantation

NeuroRegen scaffold/neural stem cells transplantation

EXPERIMENTAL

Patients receive NeuroRegen scaffold with neural stem cells transplantation after spinal cord injury.

Biological: NeuroRegen scaffold/neural stem cells transplantation

Interventions

NeuroRegen scaffold/mesenchymal stem cells transplantation BIOLOGICAL

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/mesenchymal stem cells transplantation

NeuroRegen scaffold/neural stem cells transplantation BIOLOGICAL

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.

NeuroRegen scaffold/neural stem cells transplantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18-65 years old.
• Completely spinal cord injury at the cervical and thoracic level (C5-T12).
• Classification ASIA A with no significant further improvement.
• Patients signed informed consent.
• Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.

You may not qualify if:

• 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).
• Serious complications (e.g., hydronephrosis due to renal insufficiency, severe bedsores (Ⅲ° above), lower extremity venous thrombosis, severe myositis ossificans).
• History of life threatening allergic or immune-mediated reaction.
• Clinically significant abnormalities in routine laboratory examinations (hematology, electrolytes, biochemistry, liver and kidney function tests, urinanalysis).
• History of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders.
• 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.
• Lactating and pregnant woman.
• Alcohol drug abuse /dependence.
• Participated in any other clinical trials within 3 months before the enrollment.
• A drug or treatment known to cause effect on the central nervous system during the past four weeks.
• A drug or treatment known to cause major organ system toxicity during the past four weeks.
• Poor compliance, difficult to complete the study.
• Any other conditions that might increase the risk of subjects or interfere with the clinical trial.

Sponsors & Collaborators

• Chinese Academy of Sciences: lead
• Affiliated Hospital of Logistics University of CAPF: collaborator

Study Sites (1)

Affiliated Hospital of Logistics Universtiy of CAPF

Tianjin, 300162, China

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jianwu Dai, Ph.D

  Chinese Academy of Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS

Study Record Dates

• First Submitted: February 6, 2016
• First Posted: February 23, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 23, 2020

Record last verified: 2016-02

Locations

CN (1)