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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by General Hospital of Chinese Armed Police Forces.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier:
NCT01393977
First received: July 6, 2011
Last updated: October 7, 2011
Last verified: October 2011

July 6, 2011
October 7, 2011
January 2011
December 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01393977 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Difference Between Rehabilitation Therapy and Stem Cells Transplantation in Patients With Spinal Cord Injury in China
Efficacy Difference Between Rehabilitation Therapy and Umbilical Cord Derived Mesenchymal Stem Cells Transplantation in Patients With Acute or Chronic Spinal Cord Injury in China

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.

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

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Spinal Cord Injuries
  • Procedure: rehabilitation of limb function
    only receive rehabilitation of limb function
    Other Name: phsical exercise rehabilitation
  • Procedure: Stem Cells Transplantation
    mesenchymal stem cells derived from umbilical cord are transplanted directly into subarachnoid by Lumbar puncture
    Other Name: Stem Cells Transplantation
  • No Intervention: control
    Outpatient in hospital
  • Active Comparator: rehabilitation
    interventions: rehabilitation
    Intervention: Procedure: rehabilitation of limb function
  • Experimental: Stem Cell Transplantation
    interventions: stem cell transplantation
    Intervention: Procedure: Stem Cells Transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
May 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients or their curator must be able to give voluntary consent.
  2. Patients or their curator Must be able to understand the information of study and in which group they are.
  3. 20 years - 50 years of age can be enrolled.
  4. Both male and female can be enrolled.
  5. 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:

  1. Mental disorders
  2. Myelitis
  3. Women in pregnancy
  4. Cancer
Both
20 Years to 50 Years
No
China
 
NCT01393977
2011-01-19SCI
Yes
General Hospital of Chinese Armed Police Forces
General Hospital of Chinese Armed Police Forces
Not Provided
Study Director: An Yihua, doctor Chinese People's Armed Police Force
General Hospital of Chinese Armed Police Forces
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP