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NeuroRegen Scaffold™ With Stem Cells for Chronic Spinal Cord Injury Repair

Primary Purpose

Spinal Cord Injury

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

NeuroRegen scaffold with BMMCs or MSCs transplantation

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female, 18-65 years old.
Completely spinal cord injury at the cervical and thoracic level (C5-T12).
Classification ASIA A with no significant further improvement.
Patients signed informed consent.
Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.

Exclusion Criteria:

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.

Sites / Locations

First Hospitals affiliated to the China PLA General Hospital
The First Affiliated Hospital of Soochow University
Affiliated Hospital of Logistics Universtiy of CAPF

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NeuroRegen Scaffold with BMMCs or MSCs transplantation

Arm Description

Outcomes

Primary Outcome Measures

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 with MSCs transplantation.

Secondary Outcome Measures

Improvements in Neurophysiological Measures omatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed

Somatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed before and after transplantation.

Improvements in ASIA Impairment Scale

American Spinal Injury Assessment Scale of A, B, C, D or E will be assessed before and after transplantation.

Improvements in Independence Measures and Quality of Life

Functional Independence Measure (FIM) and the Quality of Life Questionnaire (EQ 5D) will be assessed before and after transplantation.

Improvements in Pain assessed based on Visual analog scale (VAS)

Pain intensity will be assessed based on Visual analog scale (VAS) before and after transplantation.

Improvements in Urinary and Bowel Function assessed based on bladder pressure monitory before and after transplantation

The ability to feel and control urination and bowel will be assessed based on bladder pressure monitory before and after transplantation.

Changes at the Transplantation Site in Spinal Cord by Magnetic Resonance Imaging (MRI)

The MRI at the transplantation site will be assessed before and after transplantation.

Full Information

NCT ID

NCT02352077

First Posted

January 20, 2015

Last Updated

December 21, 2020

Sponsor

Chinese Academy of Sciences

Collaborators

Affiliated Hospital of Logistics University of CAPF, The First Affiliated Hospital of Soochow University, First Hospitals affiliated to the China PLA General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02352077

Brief Title

NeuroRegen Scaffold™ With Stem Cells for Chronic Spinal Cord Injury Repair

Official Title

Safety and Efficacy of NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells or Mesenchymal Stem Cells for Chronic Spinal Cord Injury Repair

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2015 (undefined)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Sciences

Collaborators

Affiliated Hospital of Logistics University of CAPF, The First Affiliated Hospital of Soochow University, First Hospitals affiliated to the China PLA General Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to assess the safety and efficacy of NeuroRegen scaffold with bone marrow mononuclear cells (BMMCs) or mesenchymal stem cells (MSCs) in patients with chronic spinal cord injury.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NeuroRegen Scaffold with BMMCs or MSCs transplantation

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

NeuroRegen scaffold with BMMCs or MSCs transplantation

Intervention Description

Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) or mesenchymal stem cells (MSCs) transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.

Primary Outcome Measure Information:

Title

Safety Evaluation Number of patients with adverse events

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Improvements in Neurophysiological Measures omatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed

Description

Somatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed before and after transplantation.

Time Frame

12 months

Title

Improvements in ASIA Impairment Scale

Description

American Spinal Injury Assessment Scale of A, B, C, D or E will be assessed before and after transplantation.

Time Frame

12 months

Title

Improvements in Independence Measures and Quality of Life

Description

Functional Independence Measure (FIM) and the Quality of Life Questionnaire (EQ 5D) will be assessed before and after transplantation.

Time Frame

12 months

Title

Improvements in Pain assessed based on Visual analog scale (VAS)

Description

Pain intensity will be assessed based on Visual analog scale (VAS) before and after transplantation.

Time Frame

12 months

Title

Improvements in Urinary and Bowel Function assessed based on bladder pressure monitory before and after transplantation

Description

The ability to feel and control urination and bowel will be assessed based on bladder pressure monitory before and after transplantation.

Time Frame

12 months

Title

Changes at the Transplantation Site in Spinal Cord by Magnetic Resonance Imaging (MRI)

Description

The MRI at the transplantation site will be assessed before and after transplantation.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, 18-65 years old. Completely spinal cord injury at the cervical and thoracic level (C5-T12). Classification ASIA A with no significant further improvement. Patients signed informed consent. Ability and willingness to regular visit to hospital and follow up during the protocol Procedures. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianwu Dai, Ph.D

Organizational Affiliation

Chinese Academy of Sciences

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sai Zhang, M.D

Organizational Affiliation

Affiliated Hospital of Logistics Universtiy of CAPF

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Huilin Yang, Ph.D

Organizational Affiliation

The First Affiliated Hospital of Soochow University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Shuxun Hou

Organizational Affiliation

First Hospitals affiliated to the China PLA General Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

First Hospitals affiliated to the China PLA General Hospital

City

Beijing

ZIP/Postal Code

100037

Country

China

Facility Name

The First Affiliated Hospital of Soochow University

City

Suzhou

ZIP/Postal Code

215006

Country

China

Facility Name

Affiliated Hospital of Logistics Universtiy of CAPF

City

Tianjin

ZIP/Postal Code

300162

Country

China

12. IPD Sharing Statement

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NeuroRegen Scaffold™ With Stem Cells for Chronic Spinal Cord Injury Repair

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