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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
Sponsor:
Information provided by (Responsible Party):
General Hospital of Chinese Armed Police Forces

Tracking Information
First Submitted Date  ICMJE July 6, 2011
First Posted Date  ICMJE July 14, 2011
Last Update Posted Date October 10, 2011
Study Start Date  ICMJE January 2011
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01393977 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2011)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Difference Between Rehabilitation Therapy and Stem Cells Transplantation in Patients With Spinal Cord Injury in China
Official Title  ICMJE Efficacy Difference Between Rehabilitation Therapy and Umbilical Cord Derived Mesenchymal Stem Cells Transplantation in Patients With Acute or Chronic Spinal Cord Injury in China
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injuries
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Cheng H, Liu X, Hua R, Dai G, Wang X, Gao J, An Y. Clinical observation of umbilical cord mesenchymal stem cell transplantation in treatment for sequelae of thoracolumbar spinal cord injury. J Transl Med. 2014 Sep 12;12:253. doi: 10.1186/s12967-014-0253-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 12, 2011)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2012
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01393977
Other Study ID Numbers  ICMJE 2011-01-19SCI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party General Hospital of Chinese Armed Police Forces
Study Sponsor  ICMJE General Hospital of Chinese Armed Police Forces
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: An Yihua, doctor Chinese People's Armed Police Force
PRS Account General Hospital of Chinese Armed Police Forces
Verification Date October 2011

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