Difference Between Rehabilitation Therapy and Stem Cells Transplantation in Patients With Spinal Cord Injury in China
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|ClinicalTrials.gov Identifier: NCT01393977|
Recruitment Status : Unknown
Verified October 2011 by General Hospital of Chinese Armed Police Forces.
Recruitment status was: Recruiting
First Posted : July 14, 2011
Last Update Posted : October 10, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Procedure: rehabilitation of limb function Procedure: Stem Cells Transplantation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||May 2012|
No Intervention: control
Outpatient in hospital
Active Comparator: rehabilitation
Procedure: rehabilitation of limb function
only receive rehabilitation of limb function
Other Name: phsical exercise rehabilitation
Experimental: Stem Cell Transplantation
interventions: stem cell transplantation
Procedure: Stem Cells Transplantation
mesenchymal stem cells derived from umbilical cord are transplanted directly into subarachnoid by Lumbar puncture
- Electromyogram and Electroneurophysiologic test [ Time Frame: 3 monthes after enrollment or transplantation ]Brain stem auditory evoked potential (BAEP)and electromyography can display the nerve conduction velocity and the improvement of neurological function.
- Electromyogram and Electroneurophysiologic test [ Time Frame: 6monthes after enrollment or transplantation ]Brain stem auditory evoked potential (BAEP)and electromyography can display the nerve conduction velocity and the improvement of neurological function.
- Electromyogram and Electroneurophysiologic test [ Time Frame: 12monthes after enrollment or transplantation ]Brain stem auditory evoked potential (BAEP)and electromyography can display the nerve conduction velocity and the improvement of neurological function.
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): NCT01393977
|Contact: Yihua An, doctor 0086-10-88276848 firstname.lastname@example.org|
|Study Director:||An Yihua, doctor||Chinese People's Armed Police Force|