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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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

Arms and Interventions

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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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
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