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Trial record 18 of 284 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Cord Injuries"

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):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Nerve and Spinal Cord Injuries Biological: Umbilical Cord Mesenchymal Stem Cells Phase 1 Phase 2

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Umbilical Cord Mesenchymal Stem Cells Transplantation for the Treatment of Spinal Cord Injury
Study Start Date : January 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
Biological: Umbilical Cord Mesenchymal Stem Cells
Intrathecal administration of UC-MSCs
Other Name: UC-MSCs
No Intervention: Control group
No UC-MSC Transplantation


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 1 month post-treatment ]
  2. Changes in electromyogram and electroneurophysiologic test [ Time Frame: baseline, 1 month, 3 months, 6 months, 12 and 24 months post-treatment ]
  3. urodynamic and bladder residual urine [ Time Frame: baseline, 1 month, 3 months, 6 months, 12 and 24 months post-treatment ]
  4. MRI [ Time Frame: baseline, 6 months, 12 and 24 months post-treatment ]
  5. 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 ]
  6. subsets of T-lymphocytes [ Time Frame: baseline, 1 month, 2 months, 3 months, 4 months pre- and post-treatment ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

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): NCT02481440


Contacts
Contact: min Li Rong, MD 862085252900 ronglm@21cn.com
Contact: Mao Pang, MD 862085252900 strive2016pm@126.com

Locations
China, Guangdong
the Third Affiliated Hospital of Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Limin Rong, M.D.    862085252900    ronglimin@21cn.com   
Sponsors and Collaborators
Limin Rong
Investigators
Principal Investigator: min Li Rong, MD Third Affiliated Hospital, Sun Yat-Sen University
More Information

Responsible Party: Limin Rong, Director of spine department, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02481440     History of Changes
Other Study ID Numbers: UC-MSC-SCI
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Limin Rong, Third Affiliated Hospital, Sun Yat-Sen University:
umbilical cord mesenchymal stem cells
spinal cord injury

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System