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Umbilical Cord Mesenchymal Stem Cells Transplantation to Patients With Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02481440
Recruitment Status : Recruiting
First Posted : June 25, 2015
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):

June 15, 2015
June 25, 2015
May 9, 2017
January 2014
December 2017   (Final data collection date for primary outcome measure)
Changes in motor and sensory assessment by the ASIA score and International Association of Neural Restoration Spinal Cord Injury Functional Rating Scale(IANR-SCIRFS) [ Time Frame: baseline, 1 month, 3 months, 6 months, 12 and 24 months post-treatment ]
Changes in motor and sensory assessment by the ASIA score [ Time Frame: baseline, 1 month, 3 months, 6 months, 12 and 24 months post-treatment ]
Complete list of historical versions of study NCT02481440 on ClinicalTrials.gov Archive Site
  • Number of participants with adverse events [ Time Frame: 1 month post-treatment ]
  • Changes in electromyogram and electroneurophysiologic test [ Time Frame: baseline, 1 month, 3 months, 6 months, 12 and 24 months post-treatment ]
  • urodynamic and bladder residual urine [ Time Frame: baseline, 1 month, 3 months, 6 months, 12 and 24 months post-treatment ]
  • MRI [ Time Frame: baseline, 6 months, 12 and 24 months post-treatment ]
  • NT3、NT4、BDNF、GDNF、NGF、CNF and TNF-α、TGF-β、IL-1β、IL-6、iNOS、IL-10 [ Time Frame: baseline, 1 month, 2 months, 3 months, 4 months post-treatment ]
  • subsets of T-lymphocytes [ Time Frame: baseline, 1 month, 2 months, 3 months, 4 months pre- and post-treatment ]
  • Number of participants with adverse events [ Time Frame: 1 month post-treatment ]
  • Changes in electromyogram and electroneurophysiologic test [ Time Frame: baseline, 1 month, 3 months, 6 months, 12 and 24 months post-treatment ]
Not Provided
Not Provided
 
Umbilical Cord Mesenchymal Stem Cells Transplantation to Patients With Spinal Cord Injury
Umbilical Cord Mesenchymal Stem Cells Transplantation for the Treatment of Spinal Cord Injury
The purpose of this study is to evaluate the safety and efficacy of intrathecal administration of allogeneic umbilical cord derived mesenchymal stem cells to patients with spinal cord injury.

Spinal cord injury(SCI) is a common severe traumatic central nervous system damage. And now the treatment of SCI is still a worldwide problem in clinic. How to improve the curative effect of SCI and restore the limb nerve function as far as possible are becoming the key problems in the clinical treatment of SCI. The current treatments for spinal cord injury mainly include surgical treatment, medical therapy, physical therapy, preventing the complications after injury, but these treatments can only make some clinical improvement in patients, most patients will also face severe nerve dysfunction. Animal experiments and clinical researches in recent years have reported using umbilical cord mesenchymal stem cells (UC-MSCs) transplantation to treat spinal cord injury, this provides a new approach of SCI treatment, but its efficacy remains controversial, and lacking of high credible prospective cohort clinical trial evidence to support.

In this study, completely or incompletely cervical, thoracic spinal cord injury participants were recruited to join in a prospective, cohort clinical trials. Intervention is subarachnoid injection of human allogeneic UC-MSCs and the main evaluation index is American spinal injury association (ASIA) score, secondary evaluation indicator is electromyogram and electroneurophysiologic test.

A monocenter prospective cohort study will be performed to evaluate the effectiveness of UC-MSCs, for the treatment of completely or incompletely spinal cord injury. The primary outcome is American spinal injury association (ASIA) score at baseline, 1 month, 3 months, 6 months, 12 and 24 months post-treatment. Secondary outcomes of the study include the number of participants with adverse events at 1 month post-treatment, electromyogram and electroneurophysiologic test at baseline, 1 month, 3 months, 6 months, 12 and 24 months post-treatment.

On the basis of the results of this trial investigators will, for the first time, have scientific evidence as to the relative safety and efficacy of UC-MSCs transplantation for the treatment of spinal cord injury.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Nerve and Spinal Cord Injuries
Biological: Umbilical Cord Mesenchymal Stem Cells
Intrathecal administration of UC-MSCs
Other Name: UC-MSCs
  • Experimental: UC-MSC Transplantation
    Intrathecal administration of up to 1x10^6 umbilical cord mesenchymal stem cells per kg to patients with spinal cord injury,every month for 4 months.
    Intervention: Biological: Umbilical Cord Mesenchymal Stem Cells
  • No Intervention: Control group
    No UC-MSC Transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
44
December 2018
December 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosed as spinal cord injury
  • Age 18 to 65
  • Ability to understand and the willingness to sign a written informed consent document
  • American Spinal Injury Association Impairment Scale A-D
  • Time between injury and enrollment greater than 2 weeks

Exclusion Criteria:

  • Patients may not be receiving any other investigational agents for treatment of spianl cord injury
  • Psychiatric, addictive or any other disorder that compromises ability to give a truly informed consent
  • Malignancy within less than 12 months
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (defined as invasive fungal infection and progressive CMV viremia), symptomatic congestive heart failure (NYH class III and IV), unstable angina pectoris, or cardiac arrhythmia.
  • Pregnant or breastfeeding women.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact: min Li Rong, MD 862085252900 ronglm@21cn.com
Contact: Mao Pang, MD 862085252900 strive2016pm@126.com
China
 
 
NCT02481440
UC-MSC-SCI
Yes
Not Provided
Plan to Share IPD: Undecided
Limin Rong, Third Affiliated Hospital, Sun Yat-Sen University
Limin Rong
Not Provided
Principal Investigator: min Li Rong, MD Third Affiliated Hospital, Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
May 2017

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