Different Efficacy Between Rehabilitation Therapy and Stem Cells Transplantation in Patients With SCI in China (SCI-III)
The morbidity of spinal cord injury (SCI) is increasing year by year 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, aiming to improve the neurological disorders of these patients, such as sensory disturbance, dyskinesia, autologous adjustment of blood pressure, dysfunction of urination, defecation and perspiration , etc. What's a pity, the efficacy of the rehabilitation therapy is unsatisfactory. 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, 300 patients will be divided into three groups and the investigators will use mesenchymal stem cells derived from umbilical cord to treat 100 SCI patients. They will also follow up 100 patients who only receive rehabilitation and another 100 patients who accept neither stem cell therapy nor rehabilitation. On this basis, the investigators can compare the efficacy of these two treatments.
Spinal Cord Injury
Procedure: cell therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Different Efficacy Between Rehabilitation Therapy and Umbilical Cord Derived Mesenchymal Stem Cells Transplantation in Patients With Chronic Spinal Cord Injury in China|
- Neurological Function Score(ASIA and Barthel Index) [ Time Frame: Change from baseline at 12 monthes after enrollment or transplantation ] [ Designated as safety issue: Yes ]
- Electromyogram and Electroneurophysiologic Test [ Time Frame: Change from baseline at 12 monthes after enrollment or transplantation ] [ Designated as safety issue: Yes ]
- Blood Test [ Time Frame: Change from baseline at 12 monthes after enrollment or transplantation ] [ Designated as safety issue: Yes ]
- red blood cell
- white blood cell
- platelet count
- alanine aminotransferase
- aspartate aminotransferase
- total bilirubin
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Active Comparator: rehabilitation
Patients in the group accept rehabilitation for three weeks in hospital and other eleven months in their home under the guidance of physical therapist.
Patients only receive rehabilitation of limb function.
Other Name: phsical exercise rehabilitation
Experimental: cell therapy
Patients in the group accept cell therapy including four times stem cells transplant via intrathecal injection.
Procedure: cell therapy
Mesenchymal stem cells derived from umbilical cord are transplanted directly into subarachnoid by Lumbar puncture.
No Intervention: control
Patients receive no professional treatment in hospital or rehabilitation centre.
Patients enrolled in this study need to finish our whole follow-up survey, which is carried out by clinical doctors and epidemiologist.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01873547
|Contact: Yihua An, Ph Dfirstname.lastname@example.org|
|Contact: Yihua An, Ph D||0086-10-57976848|
|General Hospital of Chinese People's Armed Police Forces||Recruiting|
|Beijing, Beijing, China, 100050|
|Contact: Yihua An, Ph D 0086-10-57976848 email@example.com|
|Contact: Rongrong Hua 0086-10-57976866 firstname.lastname@example.org|
|Principal Investigator: Yihua An, Ph D|
|Study Director:||Yihua An, Ph.D||the General Hospital of Chinese People's Armed Police Forces|