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

December 21, 2020 updated by: Jianwu Dai, Chinese Academy of Sciences

Safety and Efficacy of Functional Neural Regeneration Collagen Scaffold Transplantation in Complete (AISA) Acute Spinal Cord Injury Patients

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100037
        • Recruiting
        • First Hospitals affiliated to the China PLA General Hospital
        • Contact:
        • Contact:
      • Chongqing, China, 400037
        • Recruiting
        • Xinqiao Hospital of Army Medical University
        • Contact:
      • Suzhou, China, 215006
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:
          • Huilin Yang, Ph.D
        • Contact:
      • Tianjin, China, 300162
        • Recruiting
        • Affiliated Hospital of Logistics Universtiy of CAPF
        • Contact:
          • Sai Zhang, M.D
          • Phone Number: 86-22-60577101
        • Contact:
      • Yinchuan, China, 750004
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Contact:
          • Hechun Xia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
Improvements in Electrophysiological monitoring
Time Frame: 12 months
Somatosensory Evoked Potentials (SSEP) monitoring will be assessed before and after transplantation.
12 months
Improvements in Electrophysiological monitoring
Time Frame: 12 months
Motor Evoked Potentials (MEP) monitoring will be assessed before and after transplantation.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Sciences

Collaborators

The First Affiliated Hospital of Soochow University
General Hospital of Ningxia Medical University
First Hospitals affiliated to the China PLA General Hospital
Affiliated Hospital of Logistics University of CAPF
Xinqiao hospital of Army Medical University

Investigators

  • Study Chair: Hechun Xia, General Hospital of Ningxia Medical University
  • Study Chair: Tongwei Chu, Xinqiao Hospital of Army Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

July 26, 2015

First Submitted That Met QC Criteria

July 27, 2015

First Posted (Estimate)

July 29, 2015

Study Record Updates

Last Update Posted (Actual)

December 23, 2020

Last Update Submitted That Met QC Criteria

December 21, 2020

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAS-XDA-ACSCI/IGDB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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