NeuroRegen Scaffold™ With Stem Cells for Chronic Spinal Cord Injury Repair
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02352077|
Recruitment Status : Enrolling by invitation
First Posted : February 2, 2015
Last Update Posted : January 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Biological: NeuroRegen scaffold with BMMCs or MSCs transplantation||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells or Mesenchymal Stem Cells for Chronic Spinal Cord Injury Repair|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
|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.
- Safety Evaluation Number of patients with adverse events [ Time Frame: 6 months ]Number of patients with adverse events is as a measure of safety and tolerability after collagen scaffold with MSCs transplantation.
- Improvements in Neurophysiological Measures omatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed [ Time Frame: 12 months ]Somatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed before and after transplantation.
- Improvements in ASIA Impairment Scale [ Time Frame: 12 months ]American Spinal Injury Assessment Scale of A, B, C, D or E will be assessed before and after transplantation.
- Improvements in Independence Measures and Quality of Life [ Time Frame: 12 months ]Functional Independence Measure (FIM) and the Quality of Life Questionnaire (EQ 5D) will be assessed before and after transplantation.
- Improvements in Pain assessed based on Visual analog scale (VAS) [ Time Frame: 12 months ]Pain intensity will be assessed based on Visual analog scale (VAS) before and after transplantation.
- Improvements in Urinary and Bowel Function assessed based on bladder pressure monitory before and after transplantation [ Time Frame: 12 months ]The ability to feel and control urination and bowel will be assessed based on bladder pressure monitory before and after transplantation.
- Changes at the Transplantation Site in Spinal Cord by Magnetic Resonance Imaging (MRI) [ Time Frame: 12 months ]The MRI at the transplantation site will be assessed before and after transplantation.
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): NCT02352077
|First Hospitals affiliated to the China PLA General Hospital|
|Beijing, China, 100037|
|The First Affiliated Hospital of Soochow University|
|Soochow, China, 215006|
|Affiliated Hospital of Logistics Universtiy of CAPF|
|Tianjin, China, 300162|
|Principal Investigator:||Jianwu Dai, Ph.D||Chinese Academy of Sciences|
|Study Chair:||Sai Zhang, M.D||Affiliated Hospital of Logistics Universtiy of CAPF|
|Study Chair:||Huilin Yang, Ph.D||The First Affiliated Hospital of Soochow University|
|Study Chair:||Shuxun Hou||First Hospitals affiliated to the China PLA General Hospital|