Functional Neural Regeneration Collagen Scaffold Transplantation in Acute Spinal Cord Injury Patients

NCT02510365 | Unknown Phase 1

• 1 other identifier: CAS-XDA-ACSCI/IGDB
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

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.

Conditions

Acute Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• Safety Evaluation Number of patients with adverse events

  Number of patients with adverse events is as a measure of safety and tolerability after collagen scaffold transplantation.

  6 months

Secondary Outcomes (3)

• Improvements in ASIA Impairment Scale

  12 months

• Improvements in Electrophysiological monitoring

  12 months

• Improvements in Electrophysiological monitoring

  12 months

Study Arms (1)

Functional collagen scaffold

EXPERIMENTAL

Functional neural regeneration collagen scaffold transplantation.

Biological: Functional collagen scaffold

Interventions

Functional collagen scaffold BIOLOGICAL

Patients will receive functional neural regeneration collagen scaffold and patients will undergo a comprehensive rehabilitation and psychological measures after surgery.

Functional collagen scaffold

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18-65 years old.
• Completely spinal cord injury at the cervical and thoracic level (C4-T12).
• Classification ASIA A, occurring within past 21 days.
• Patients signed informed consent.
• Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.

You may not qualify if:

• 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).
• Serious complications (e.g., hydronephrosis due to renal insufficiency, severe bedsores (Ⅲ° above), lower extremity venous thrombosis, severe myositis ossificans).
• History of life threatening allergic or immune-mediated reaction.
• Clinically significant abnormalities in routine laboratory examinations (hematology, electrolytes, biochemistry, liver and kidney function tests, urinanalysis).
• History of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders.
• 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.
• Lactating and pregnant woman.
• Alcohol drug abuse /dependence.
• Participated in any other clinical trials within 3 months before the enrollment.
• A drug or treatment known to cause effect on the central nervous system during the past four weeks.
• A drug or treatment known to cause major organ system toxicity during the past four weeks.
• Poor compliance, difficult to complete the study.
• Any other conditions that might increase the risk of subjects or interfere with the clinical trial.

Sponsors & Collaborators

• Chinese Academy of Sciences: lead
• Affiliated Hospital of Logistics University of CAPF: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• First Hospitals affiliated to the China PLA General Hospital: collaborator
• General Hospital of Ningxia Medical University: collaborator
• Army Medical University, China: collaborator

Study Sites (5)

First Hospitals affiliated to the China PLA General Hospital

Beijing, 100037, China

RECRUITING

Xinqiao Hospital of Army Medical University

Chongqing, 400037, China

RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, 215006, China

RECRUITING

Affiliated Hospital of Logistics Universtiy of CAPF

Tianjin, 300162, China

RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, 750004, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 32862715 DERIVED

• 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.

  PMID: 29871514 DERIVED

Study Officials

• Jianwu Dai, Ph.D

  Chinese Academy of Sciences

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

• Tongwei Chu

  Army Medical University, China

  STUDY CHAIR

Central Study Contacts

Zhifeng Xiao, Ph.D

CONTACT

86-10-82614420; zfxiao@genetics.ac.cn

Sufang Han, Ph.D

CONTACT

86-10-82614420; sufanghan22@genetics.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS

Study Record Dates

• First Submitted: July 26, 2015
• First Posted: July 29, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 23, 2020

Record last verified: 2015-07

Locations

CN (5)