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Trial record 10 of 36 for:    stem cell Spinal Cord Injury AND transplantation

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

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ClinicalTrials.gov Identifier: NCT03521323
Recruitment Status : Recruiting
First Posted : May 10, 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

Tracking Information
First Submitted Date  ICMJE April 12, 2018
First Posted Date  ICMJE May 10, 2018
Last Update Posted Date May 1, 2019
Estimated Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03521323 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2018)
  • 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)
  • Changes in electromyogram test [ Time Frame: Baseline, 6 months and 12 months post-treatment ]
    Changes in electromyogram test
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intrathecal Transplantation of UC-MSC in Patients With Early Stage of Chronic Spinal Cord Injury
Official Title  ICMJE 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
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 early stage of chronic 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Spinal Cord Injuries
Intervention  ICMJE
  • Drug: Umbilical Cord Mesenchymal Stem Cells
    Intrathecal Transplantation of Umbilical Cord Mesenchymal Stem Cells
    Other Name: UC-MSC
  • Drug: Placebos
    Placebos: Saline,Sham operation
    Other Name: Sham operation
Study Arms  ICMJE
  • 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
    Intervention: Drug: Umbilical Cord Mesenchymal Stem Cells
  • Placebo Comparator: Control
    Sham operation and 10ml saline as placebos, once a month for 4 months
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 18, 2018)
66
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2018)
92
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Limin Rong, M.D. 862085252900 ronglm@21cn.com
Contact: Liangming Zhang, M.D. 862085252900 leven_zhang@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03521323
Other Study ID Numbers  ICMJE IT-UCMSC-ECSCI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Limin Rong, Third Affiliated Hospital, Sun Yat-Sen University
Study Sponsor  ICMJE Third Affiliated Hospital, Sun Yat-Sen University
Collaborators  ICMJE
  • West China Hospital
  • Shanghai East Hospital
Investigators  ICMJE
Principal Investigator: Limin Rong, M.D. Sun Yat-sen University
PRS Account Third Affiliated Hospital, Sun Yat-Sen University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP