Functional Neural Regeneration Collagen Scaffold Transplantation in Acute Spinal Cord Injury Patients
|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: NCT02510365|
Recruitment Status : Recruiting
First Posted : July 29, 2015
Last Update Posted : January 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Spinal Cord Injury||Biological: Functional collagen scaffold||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Functional Neural Regeneration Collagen Scaffold Transplantation in Complete (AISA) Acute Spinal Cord Injury Patients|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Functional collagen scaffold
Functional neural regeneration collagen scaffold transplantation.
Biological: Functional collagen scaffold
Patients will receive functional neural regeneration collagen scaffold and patients will undergo a comprehensive rehabilitation and psychological measures after surgery.
- 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 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 Electrophysiological monitoring [ Time Frame: 12 months ]Somatosensory Evoked Potentials (SSEP) monitoring will be assessed before and after transplantation.
- Improvements in Electrophysiological monitoring [ Time Frame: 12 months ]Motor Evoked Potentials (MEP) monitoring will be assessed before and after transplantation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02510365
|Contact: Zhifeng Xiao, Ph.Demail@example.com|
|Contact: Sufang Han, Ph.Dfirstname.lastname@example.org|
|First Hospitals affiliated to the China PLA General Hospital||Recruiting|
|Beijing, China, 100037|
|Contact: Shuxun Hou 86-10-66867350 email@example.com|
|Contact: Jiaguang Tang, Ph.D 86-10-6684837 firstname.lastname@example.org|
|The First Affiliated Hospital of Soochow University||Recruiting|
|Suzhou, China, 215006|
|Contact: Huilin Yang, Ph.D|
|Contact: Qin Shi, Ph.D 86-512-67781169 email@example.com|
|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 firstname.lastname@example.org|
|General Hospital of Ningxia Medical University||Recruiting|
|Yinchuan, China, 750004|
|Contact: Hechun Xia|
|Contact: Xueyun Liang email@example.com|
|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|
|Study Chair:||Hechun Xia||General Hospital of Ningxia Medical University|