NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells Transplantation vs. Intradural Decompression and Adhesiolysis in SCI
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02688062|
Recruitment Status : Recruiting
First Posted : February 23, 2016
Last Update Posted : January 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Biological: NeuroRegen Scaffold with BMMCs transplantation Procedure: Surgical intradural decompression and adhesiolysis||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells Transplantation vs. Intradural Decompression and Adhesiolysis in Patients With Chronic Spinal Cord Injury|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
|Experimental: NeuroRegen Scaffold with BMMCs transplantation||
Biological: NeuroRegen Scaffold with BMMCs transplantation
Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
|Experimental: Surgical intradural decompression and adhesiolysis||
Procedure: Surgical intradural decompression and adhesiolysis
Patients with chronic SCI (ASIA grade A) will receive intradural decompression and adhesiolysis surgery and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
- Improvements in ASIA (American Spinal Injury Association) Impairment Scale [ Time Frame: 24 months ]
- Improvements in Somatosensory Evoked Potentials (SSEP) [ Time Frame: 24 months ]
- Improvements in Motor Evoked Potentials (MEP) [ Time Frame: 24 months ]
- 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.
- Magnetic Resonance Imaging (MRI) [ Time Frame: 1, 3, 6, 12, 18 and 24 months ]The change of treated spinal cord injury will be assessed by Magnetic Resonance Imaging (MRI) before and after surgery.
- 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.
- 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.
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): NCT02688062
|Contact: Zhifeng Xiao, Ph.D.||firstname.lastname@example.org|
|Contact: Sufang Han, Ph.D.||email@example.com|
|First Affiliated Hospital of PLA General Hospital||Recruiting|
|Beijing, China, 100101|
|Contact: Jiaguang Tang, M.D. 86-10-66848872 firstname.lastname@example.org|
|Contact: Xiaoxiong Yang 86-10-66848873 email@example.com|
|Principal Investigator:||Jianwu Dai, Ph.D.||Chinese Academy of Sciences|