NCT03521336

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 1, 2019

Status Verified

April 1, 2019

Enrollment Period

2.3 years

First QC Date

April 12, 2018

Last Update Submit

April 29, 2019

Conditions

Spinal Cord Injury

Keywords

Spinal cord injuryUmbilical Cord Mesenchymal Stem Cells

Outcome Measures

Primary Outcomes (1)

  • 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)

    baseline, 1 month, 3 months, 6 months and 12 months post-treatment

Secondary Outcomes (3)

  • Changes in International Association of Neural Restoration Spinal Cord Injury Functional Rating Scale (IANR-SCIRFS)

    Baseline, 1 month, 3 months, 6 months and 12 months post-treatment

  • Changes in electromyogram test

    Baseline, 6 months and 12 months post-treatment

  • Changes in residual urine

    Baseline, 6 months and 12 months post-treatment

Study Arms (2)

Umbilical Cord Mesenchymal Stem Cells

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Umbilical Cord Mesenchymal Stem CellsDRUG

Intrathecal Transplantation of Umbilical Cord Mesenchymal Stem Cells

Also known as: UC-MSC
Umbilical Cord Mesenchymal Stem Cells
PlaceboDRUG

Saline，Sham operation

Also known as: Sham operation
Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Limin Rong, M.D.

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Limin Rong, M.D.

CONTACT

862085252900ronglm@21cn.com

Liangming Zhang, M.D.

CONTACT

862085252900leven_zhang@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A 2:1 ratio of randomization (intervention group:control group) was used.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, President, Director of Department of Spine Surgery

Study Record Dates

First Submitted

April 12, 2018

First Posted

May 11, 2018

Study Start

September 1, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

May 1, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)