We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03521336
Recruitment Status : Unknown
Verified April 2019 by Limin Rong, Third Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Recruiting
First Posted : May 11, 2018
Last Update Posted : May 1, 2019
Sponsor:
Collaborators:
West China Hospital
Shanghai East Hospital
Information provided by (Responsible Party):
Limin Rong, Third Affiliated Hospital, Sun Yat-Sen University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injury Drug: Umbilical Cord Mesenchymal Stem Cells Drug: Placebo Phase 2

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A 2:1 ratio of randomization (intervention group:control group) was used.
Masking: Single (Participant)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Umbilical Cord Mesenchymal Stem Cells
Intrathecal Transplantation of Umbilical Cord Mesenchymal Stem Cells, 1*10^6 cells/kg, once a month for 4 months
 Drug: Umbilical Cord Mesenchymal Stem Cells
Intrathecal Transplantation of Umbilical Cord Mesenchymal Stem Cells
Other Name: UC-MSC
Placebo Comparator: Control
Placebo: Sham operation, 10ml saline, once a month for 4 months
 Drug: Placebo
Saline，Sham operation
Other Name: Sham operation


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Changes in American Spinal Injury Association (ASIA) Score Scale [ Time Frame: baseline, 1 month, 3 months, 6 months and 12 months post-treatment ]
    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 :
  1. Changes in International Association of Neural Restoration Spinal Cord Injury Functional Rating Scale (IANR-SCIRFS) [ Time Frame: Baseline, 1 month, 3 months, 6 months and 12 months post-treatment ]
    Changes in motor and sensory scores assessed by IANR-SCIRFS scale (total score range from 0 to 51, higher values represent a better outcome)

  2. Changes in electromyogram test [ Time Frame: Baseline, 6 months and 12 months post-treatment ]
    Changes in electromyogram test

  3. Changes in residual urine [ Time Frame: Baseline, 6 months and 12 months post-treatment ]
    Changes in residual urine measured by ultrasound test (volume of urine in mL, lower values represent a better outcome)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03521336


Contacts
Layout table for location contacts
Contact: Limin Rong, M.D. 862085252900 ronglm@21cn.com
Contact: Liangming Zhang, M.D. 862085252900 leven_zhang@163.com

Locations
Layout table for location information
China, Guangdong
Third Affiliated Hospital of Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Limin Rong, M.D.    8620-85252900    ronglimin@21cn.com   
Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
West China Hospital
Shanghai East Hospital
Investigators
Layout table for investigator information
Principal Investigator: Limin Rong, M.D. Sun Yat-sen University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Limin Rong, Professor, President, Director of Department of Spine Surgery, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03521336    
Other Study ID Numbers: IT-UCMSC-SASCI
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Limin Rong, Third Affiliated Hospital, Sun Yat-Sen University:
Spinal cord injury
Umbilical Cord Mesenchymal Stem Cells
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System