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Trial record 1 of 1 for:    NCT02688049
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NeuroRegen Scaffold™ Combined With Stem Cells for Chronic Spinal Cord Injury Repair

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ClinicalTrials.gov Identifier: NCT02688049
Recruitment Status : Recruiting
First Posted : February 23, 2016
Last Update Posted : July 16, 2018
Sponsor:
Collaborator:
Affiliated Hospital of Logistics University of CAPF
Information provided by (Responsible Party):
Jianwu Dai, Chinese Academy of Sciences

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Biological: NeuroRegen scaffold/mesenchymal stem cells transplantation Biological: NeuroRegen scaffold/neural stem cells transplantation Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of NeuroRegen Scaffold™ Combined With Mesenchymal Stem Cells or Neural Stem Cells for Chronic Spinal Cord Injury Repair
Study Start Date : January 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Improvements in ASIA (American Spinal Injury Association) Impairment Scale [ Time Frame: 24 months ]
  2. Improvements in Somatosensory Evoked Potentials (SSEP) [ Time Frame: 24 months ]
  3. Improvements in Motor Evoked Potentials (MEP) [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688049


Contacts
Contact: Zhifeng Xiao, Ph.D 86-10-82614420 zfxiao@genetics.ac.cn
Contact: Sufang Han, Ph.D 86-10-82614420 sufanghan22@genetics.ac.cn

Locations
China
Affiliated Hospital of Logistics Universtiy of CAPF Recruiting
Tianjin, China, 300162
Contact: Sai Zhang, M.D.    86-22-60577101      
Contact: Shixiang Cheng    86-22-60577171    shixiangcheng@vip.126.com   
Sponsors and Collaborators
Chinese Academy of Sciences
Affiliated Hospital of Logistics University of CAPF
Investigators
Principal Investigator: Jianwu Dai, Ph.D Chinese Academy of Sciences

Responsible Party: Jianwu Dai, Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT02688049     History of Changes
Other Study ID Numbers: CAS-XDA-MNSCI/IGDB
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: February 2016

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System