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Intrathecal Transplantation of UC-MSC in Patients With Sub-Acute Spinal Cord Injury

Primary Purpose

Spinal Cord Injury

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Umbilical Cord Mesenchymal Stem Cells
Placebo
Sponsored by
Third Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Spinal cord injury, Umbilical Cord Mesenchymal Stem Cells

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18 to 65
  • Traumatic spinal cord injury
  • ASIA Impairment Scale A-D
  • Participants who understand and sign inform consent
  • Duration of injury from 2 weeks to 2 months

Exclusion Criteria:

  • Traumatic spinal cord injury with brain injury
  • Non-traumatic spinal cord injury caused by spinal tumors, myelitis, demyelination, spinal vascular malformation, etc.
  • with Ankylosing spondylitis
  • with Malignant tumors
  • with Neurodegenerative diseases, or any neuropathies
  • with Hematologic diseases, or blood coagulation disorder
  • with Hepatic dysfunction, renal dysfunction
  • Ongoing or active infectious diseases
  • Pregnancy, or lactation women
  • Psychiatric, addictive or any other disorder that compromises ability to give a truly informed consent
  • Not agree to take part in clinical trial or can't finish follow up
  • Previous history of MSCs therapy
  • Participation in another clinical trial

Sites / Locations

  • Third Affiliated Hospital of Sun Yat-Sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Umbilical Cord Mesenchymal Stem Cells

Control

Arm Description

Intrathecal Transplantation of Umbilical Cord Mesenchymal Stem Cells, 1*10^6 cells/kg, once a month for 4 months

Placebo: Sham operation, 10ml saline, once a month for 4 months

Outcomes

Primary Outcome Measures

Changes in American Spinal Injury Association (ASIA) Score Scale
Changes in motor and sensory scores assessed by the ASIA score scale (total score range from 0 to 324, higher values represent a better outcome)

Secondary Outcome Measures

Changes in International Association of Neural Restoration Spinal Cord Injury Functional Rating Scale (IANR-SCIRFS)
Changes in motor and sensory scores assessed by IANR-SCIRFS scale (total score range from 0 to 51, higher values represent a better outcome)
Changes in electromyogram test
Changes in electromyogram test
Changes in residual urine
Changes in residual urine measured by ultrasound test (volume of urine in mL, lower values represent a better outcome)

Full Information

First Posted
April 12, 2018
Last Updated
April 29, 2019
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Collaborators
West China Hospital, Shanghai East Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03521336
Brief Title
Intrathecal Transplantation of UC-MSC in Patients With Sub-Acute Spinal Cord Injury
Official Title
The Effect of Intrathecal Transplantation of Umbilical Cord Mesenchymal Stem Cells in Patients With Sub-Acute Spinal Cord Injury:A Multicenter, Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Collaborators
West China Hospital, Shanghai East Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aim to evaluate the safety and efficacy of intrathecal transplantation of allogeneic umbilical cord derived mesenchymal stem cells (UC-MSC) for treatment of different phrases of spinal cord injury. Here, the history of spinal cord injury is divided into three periods, Sub-acute SCI, Early stage of chronic SCI, and Late stage of chronic SCI, which is 2W-2M, 2M-12M, and more than 12M after injury, respectively. The purpose is to investigate whether the patients with spinal cord injury benefit from UC-MSC transplantation, and then find out the best time for SCI treatment. In this part of the study, the investigators will treat patients with sub-acute spinal cord injury with UC-MSC transplantation or placebo.
Detailed Description
Spinal cord injury (SCI), damage to any part of the spinal cord or nerves, often causes permanent neurofunction deficit, including strength, sensation and other body functions below the site of injury. WHO reported 15-40/million people suffer from SCI each year, about 250,000 to 500,000 people. The majority of SCI victims are young patients, who are at the time of working age. As a result of that, SCI not only affects the physical and psychological health of those patients, but also bring huge economic burden to their families, as well as the society. The current treatments for SCI mainly include surgical operation, neuroregenerative medicine, physical therapy, chinese acupuncture and so on. However, none of these methods are efficient enough to make any functional recovery of neurological injury in patients, and most patients will have to face paraplegia or tetraplegia. The most challenge of SCI treatment are reported to be regeneration of axon and rewiring of the damaged spinal cord. The properties of strong proliferation and differentiation make stem cell transplantation possible to replace the damage axon and rebridge the injury spinal cord. Currently, evidences from animal experiments and pilot clinical studies have reported that umbilical cord mesenchymal stem cells transplantation was a potential method to treat spinal cord injury, but its safety and efficacy remain controversial. This study will conduct a multicenter, randomized, controlled trial for UC-MSC transplantation for the treatment of different phrases of SCI, including sub-acute, early stage, and late stage of chronic SCI. These three trials will investigate the safety and efficacy of intrathecal transplantation of UC-MSC in patients with SCI treatment. The study will be conducted at 3 hospitals in China, covering eastern, southern and western of Chinese mainland. The primary outcome is the changes of motor and sensory assessment before and after intervention using American Spinal Injury Association (ASIA) Score Scale. Secondary outcomes will include International Association of Neural Restoration Spinal Cord Injury Functional Rating Scale (IANR-SCIRFS), electromyogram test, residual urine test and adverse events. The enrolled participants will be followed up at baseline, 1, 3, 6 and 12 months after UC-MSC transplantation. Besides, the samples of serum and cerebrospinal fluid will be collected, before and after treatment, to explore the potential mechanism of UC-MSC transplantation for the treatment of SCI. The results of this study will, for the first time, provide high level of evidence as to the relative safety and efficacy of UC-MSC transplantation for the treatment of 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
Keywords
Spinal cord injury, Umbilical Cord Mesenchymal Stem Cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A 2:1 ratio of randomization (intervention group:control group) was used.
Masking
Participant
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Umbilical Cord Mesenchymal Stem Cells
Arm Type
Experimental
Arm Description
Intrathecal Transplantation of Umbilical Cord Mesenchymal Stem Cells, 1*10^6 cells/kg, once a month for 4 months
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo: Sham operation, 10ml saline, once a month for 4 months
Intervention Type
Drug
Intervention Name(s)
Umbilical Cord Mesenchymal Stem Cells
Other Intervention Name(s)
UC-MSC
Intervention Description
Intrathecal Transplantation of Umbilical Cord Mesenchymal Stem Cells
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sham operation
Intervention Description
Saline,Sham operation
Primary Outcome Measure Information:
Title
Changes in American Spinal Injury Association (ASIA) Score Scale
Description
Changes in motor and sensory scores assessed by the ASIA score scale (total score range from 0 to 324, higher values represent a better outcome)
Time Frame
baseline, 1 month, 3 months, 6 months and 12 months post-treatment
Secondary Outcome Measure Information:
Title
Changes in International Association of Neural Restoration Spinal Cord Injury Functional Rating Scale (IANR-SCIRFS)
Description
Changes in motor and sensory scores assessed by IANR-SCIRFS scale (total score range from 0 to 51, higher values represent a better outcome)
Time Frame
Baseline, 1 month, 3 months, 6 months and 12 months post-treatment
Title
Changes in electromyogram test
Description
Changes in electromyogram test
Time Frame
Baseline, 6 months and 12 months post-treatment
Title
Changes in residual urine
Description
Changes in residual urine measured by ultrasound test (volume of urine in mL, lower values represent a better outcome)
Time Frame
Baseline, 6 months and 12 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 to 65 Traumatic spinal cord injury ASIA Impairment Scale A-D Participants who understand and sign inform consent Duration of injury from 2 weeks to 2 months Exclusion Criteria: Traumatic spinal cord injury with brain injury Non-traumatic spinal cord injury caused by spinal tumors, myelitis, demyelination, spinal vascular malformation, etc. with Ankylosing spondylitis with Malignant tumors with Neurodegenerative diseases, or any neuropathies with Hematologic diseases, or blood coagulation disorder with Hepatic dysfunction, renal dysfunction Ongoing or active infectious diseases Pregnancy, or lactation women Psychiatric, addictive or any other disorder that compromises ability to give a truly informed consent Not agree to take part in clinical trial or can't finish follow up Previous history of MSCs therapy Participation in another clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Limin Rong, M.D.
Phone
862085252900
Email
ronglm@21cn.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liangming Zhang, M.D.
Phone
862085252900
Email
leven_zhang@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Limin Rong, M.D.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Third Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Limin Rong, M.D.
Phone
8620-85252900
Email
ronglimin@21cn.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Intrathecal Transplantation of UC-MSC in Patients With Sub-Acute Spinal Cord Injury

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