Clinical trial NCT02510365: Functional Neural Regeneration Collagen Scaffold Transplantation in Acute Spinal Cord Injury Patients
Official title: Safety and Efficacy of Functional Neural Regeneration Collagen Scaffold Transplantation in Complete (AISA) Acute Spinal Cord Injury Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Acute Spinal Cord Injury
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: Affiliated Hospital of Logistics University of CAPF
name: The First Affiliated Hospital of Soochow University
name: First Hospitals affiliated to the China PLA General Hospital
name: General Hospital of Ningxia Medical University
name: Army Medical University, China
First posted: 2015-07-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is designed to assess the safety and efficacy of functional neural regeneration collagen scaffold transplanted into acute spinal cord injury patients.


Eligibility criteria: Inclusion Criteria:

1. Male or female, 18-65 years old.
2. Completely spinal cord injury at the cervical and thoracic level (C4-T12).
3. Classification ASIA A, occurring within past 21 days.
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.

Primary outcomes:
measure: Safety Evaluation Number of patients with adverse events
timeFrame: 6 months
Secondary outcomes:
measure: Improvements in ASIA Impairment Scale
timeFrame: 12 months
measure: Improvements in Electrophysiological monitoring
timeFrame: 12 months
measure: Improvements in Electrophysiological monitoring
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: First Hospitals affiliated to the China PLA General Hospital
city: Chongqing
country: China
facility: Xinqiao Hospital of Army Medical University
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
city: Tianjin
country: China
facility: Affiliated Hospital of Logistics Universtiy of CAPF
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
Study officials:
affiliation: Chinese Academy of Sciences
name: Jianwu Dai, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Hospital of Logistics Universtiy of CAPF
name: Sai Zhang, M.D
role: STUDY_CHAIR
affiliation: The First Affiliated Hospital of Soochow University
name: Huilin Yang, Ph.D
role: STUDY_CHAIR
affiliation: First Hospitals affiliated to the China PLA General Hospital
name: Shuxun Hou
role: STUDY_CHAIR
affiliation: General Hospital of Ningxia Medical University
name: Hechun Xia
role: STUDY_CHAIR
affiliation: Army Medical University, China
name: Tongwei Chu
role: STUDY_CHAIR
References:
citation: Chen W, Zhang Y, Yang S, Sun J, Qiu H, Hu X, Niu X, Xiao Z, Zhao Y, Zhou Y, Dai J, Chu T. NeuroRegen Scaffolds Combined with Autologous Bone Marrow Mononuclear Cells for the Repair of Acute Complete Spinal Cord Injury: A 3-Year Clinical Study. Cell Transplant. 2020 Jan-Dec;29:963689720950637. doi: 10.1177/0963689720950637.
citation: Xiao Z, Tang F, Zhao Y, Han G, Yin N, Li X, Chen B, Han S, Jiang X, Yun C, Zhao C, Cheng S, Zhang S, Dai J. Significant Improvement of Acute Complete Spinal Cord Injury Patients Diagnosed by a Combined Criteria Implanted with NeuroRegen Scaffolds and Mesenchymal Stem Cells. Cell Transplant. 2018 Jun;27(6):907-915. doi: 10.1177/0963689718766279. Epub 2018 Jun 5.