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

December 21, 2020 updated by: Jianwu Dai, Chinese Academy of Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Tianjin, China, 300162
        • Affiliated Hospital of Logistics Universtiy of CAPF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NeuroRegen scaffold/mesenchymal stem cells transplantation
Patients receive NeuroRegen scaffold with mesenchymal stem cells transplantation after spinal cord injury.
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.
Experimental: NeuroRegen scaffold/neural stem cells transplantation
Patients receive NeuroRegen scaffold with neural stem cells transplantation after spinal cord injury.
Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvements in ASIA (American Spinal Injury Association) Impairment Scale
Time Frame: 24 months
24 months
Improvements in Somatosensory Evoked Potentials (SSEP)
Time Frame: 24 months
24 months
Improvements in Motor Evoked Potentials (MEP)
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvements in Independence Measures
Time Frame: 1, 3, 6, 12, 18 and 24 months
Functional Independence Measure (FIM) will be assessed before and after surgery.
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
The MRI at the transplantation site will be assessed before and after transplantation.
1, 3, 6, 12, 18 and 24 months
Improvements in Urinary and Bowel Function
Time Frame: 1, 3, 6, 12, 18 and 24 months
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
Safety and Tolerability assessed by Adverse Events
Time Frame: Up to 6 months
Proportion of patients with postoperative infections and serious adverse events (SAEs) will be assessed by long term follow-up.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Sciences

Collaborators

Affiliated Hospital of Logistics University of CAPF

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

February 6, 2016

First Submitted That Met QC Criteria

February 17, 2016

First Posted (Estimate)

February 23, 2016

Study Record Updates

Last Update Posted (Actual)

December 23, 2020

Last Update Submitted That Met QC Criteria

December 21, 2020

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAS-XDA-MNSCI/IGDB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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