Difference Between Rehabilitation Therapy and Stem Cells Transplantation in Patients With Spinal Cord Injury in China
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Spinal Cord Injuries |
Procedure: rehabilitation of limb function Procedure: Stem Cells Transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Electromyogram and Electroneurophysiologic test [ Time Frame: 3 monthes after enrollment or transplantation ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Brain stem auditory evoked potential (BAEP)and electromyography can display the nerve conduction velocity and the improvement of neurological function.
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: control
Outpatient in hospital
|
|
|
Active Comparator: rehabilitation
interventions: 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
Other Name: Stem Cells Transplantation
|
Detailed Description:
Patients enrolled in this study need to finish our whole follow-up survey, which is carried out by clinical doctors and epidemiologist.
Eligibility| Ages Eligible for Study: | 20 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| China | |
| Yihua An | Recruiting |
| Beijing, China | |
| Contact: Yihua An, doctor 0086-10-88276848 doctoran2010@hotmail.com | |
| Study Director: | An Yihua, doctor | Chinese People's Armed Police Force |
More Information
No publications provided
| Responsible Party: | General Hospital of Chinese Armed Police Forces |
| ClinicalTrials.gov Identifier: | NCT01393977 History of Changes |
| Other Study ID Numbers: | 2011-01-19SCI |
| Study First Received: | July 6, 2011 |
| Last Updated: | October 7, 2011 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by General Hospital of Chinese Armed Police Forces:
|
Spinal Cord Injuries Stem Cell Transplantation Rehabilitation |
Additional relevant MeSH terms:
|
Retinitis Pigmentosa Spinal Cord Injuries Eye Diseases, Hereditary Eye Diseases Retinal Dystrophies Retinal Degeneration Retinal Diseases |
Genetic Diseases, Inborn Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013