Difference Between Rehabilitation Therapy and Stem Cells Transplantation in Patients With Spinal Cord Injury in China

Study Overview
=================
Brief Summary
-----------------
The morbidity of spinal cord injury (SCI) is increasing significantly in China. The methods to treat SCI patients in sequela stage update are poor. Though traditional rehabilitation therapy is the routine method to treat SCI in sequela stage, its effect to improve the neurological disorders of these patients, such as the dysfunction of sense, motor, autologous adjustment of blood pressure control of urination and defecation, perspiration , etc. is unsatisfying. Rehabilitation Therapy can prevent the process of muscle atrophy and joint stiffness. However, it can not repair the damaged nerve function. Studies show that mesenchymal stem cell transplantation can remarkably improve the neurological function of SCI in animals without any severe side effect. In this study, the investigators use mesenchymal stem cells derived from umbilical cord to treat 40 SCI patients (20 cases in early stage and 20 cases in sequela stage). The investigators also follow-up ten patients who only receive rehabilitation and another ten outpatients who accept neither stem cell therapy nor rehabilitation. On this basis, the investigators can compare the efficacy of these two treatments.

Detailed Description
-----------------
Patients enrolled in this study need to finish our whole follow-up survey, which is carried out by clinical doctors and epidemiologist.

Official Title
-----------------
Efficacy Difference Between Rehabilitation Therapy and Umbilical Cord Derived Mesenchymal Stem Cells Transplantation in Patients With Acute or Chronic Spinal Cord Injury in China

Conditions
-----------------
Spinal Cord Injuries

Intervention / Treatment
-----------------
* Procedure: rehabilitation of limb function
* Procedure: Stem Cells Transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients or their curator must be able to give voluntary consent. Patients or their curator Must be able to understand the information of study and in which group they are. 20 years - 50 years of age can be enrolled. Both male and female can be enrolled. Patients have clear history of traumatic injury, and the spinal cord injury are confirmed by all of the examinations including MRI, electromyogram and electrophysiology. Exclusion Criteria: Mental disorders Myelitis Women in pregnancy Cancer

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>Outpatient in hospital | |
| Active Comparator: rehabilitation<br>interventions: rehabilitation | Procedure: rehabilitation of limb function<br>* only receive rehabilitation of limb function<br>* Other names: phsical exercise rehabilitation;|
| Experimental: Stem Cell Transplantation<br>interventions: stem cell transplantation | Procedure: Stem Cells Transplantation<br>* mesenchymal stem cells derived from umbilical cord are transplanted directly into subarachnoid by Lumbar puncture<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electromyogram and Electroneurophysiologic test | Brain stem auditory evoked potential (BAEP)and electromyography can display the nerve conduction velocity and the improvement of neurological function. | 3 monthes after enrollment or transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electromyogram and Electroneurophysiologic test | Brain stem auditory evoked potential (BAEP)and electromyography can display the nerve conduction velocity and the improvement of neurological function. | 6monthes after enrollment or transplantation | 
| Electromyogram and Electroneurophysiologic test | Brain stem auditory evoked potential (BAEP)and electromyography can display the nerve conduction velocity and the improvement of neurological function. | 12monthes after enrollment or transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal Cord Injuries, Stem Cell Transplantation, Rehabilitation