Umbilical Cord Mesenchymal Stem Cells Transplantation to Patients With Spinal Cord Injury
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| ClinicalTrials.gov Identifier: NCT02481440 |
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Recruitment Status :
Recruiting
First Posted : June 25, 2015
Last Update Posted : May 9, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Nerve and Spinal Cord Injuries | Biological: Umbilical Cord Mesenchymal Stem Cells | Phase 1 Phase 2 |
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 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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Biological: Umbilical Cord Mesenchymal Stem Cells
Intrathecal administration of UC-MSCs
Other Name: UC-MSCs |
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No Intervention: Control group
No UC-MSC Transplantation
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- 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 ]
- 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 ]
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
| Contact: min Li Rong, MD | 862085252900 | ronglm@21cn.com | |
| Contact: Mao Pang, MD | 862085252900 | strive2016pm@126.com |
| 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 | |
| Principal Investigator: | min Li Rong, MD | Third Affiliated Hospital, Sun Yat-Sen University |
| 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:
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umbilical cord mesenchymal stem cells spinal cord injury |
Additional relevant MeSH terms:
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Wounds and Injuries Spinal Cord Injuries Spinal Cord Diseases |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System |