Intrathecal Transplantation of UC-MSC in Patients With Early Stage of Chronic Spinal Cord Injury

April 29, 2019 updated by: Limin Rong, Third Affiliated Hospital, Sun Yat-Sen University

The Effect of Intrathecal Transplantation of Umbilical Cord Mesenchymal Stem Cells in Patients With Early Stage of Chronic Spinal Cord Injury：A Multicenter, Randomized, Controlled Trial

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 early stage of chronic spinal cord injury with UC-MSC transplantation or placebo.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • The Third Affiliated Hospital, Sun Yat-sen University
        • 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:

  • 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 months to 12 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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • UC-MSC
Placebo Comparator: Control
Sham operation and 10ml saline as placebos, once a month for 4 months
Drug: Placebos
Placebos: Saline，Sham operation
Other Names:
  • Sham operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, 1 month, 3 months, 6 months and 12 months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, 1 month, 3 months, 6 months and 12 months post-treatment
Changes in electromyogram test
Time Frame: Baseline, 6 months and 12 months post-treatment
Changes in electromyogram test
Baseline, 6 months and 12 months post-treatment
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)
Baseline, 6 months and 12 months post-treatment

Collaborators and Investigators

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

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Collaborators

West China Hospital
Shanghai East Hospital

Investigators

  • Principal Investigator: Limin Rong, M.D., Sun Yat-sen 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 (Anticipated)

September 1, 2019

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

April 12, 2018

First Submitted That Met QC Criteria

May 9, 2018

First Posted (Actual)

May 11, 2018

Study Record Updates

Last Update Posted (Actual)

May 1, 2019

Last Update Submitted That Met QC Criteria

April 29, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IT-UCMSC-ECSCI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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