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Different Efficacy Between Rehabilitation Therapy and Stem Cells Transplantation in Patients With SCI in China (SCI-III)

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ClinicalTrials.gov Identifier: NCT01873547
Recruitment Status : Unknown
Verified June 2013 by General Hospital of Chinese Armed Police Forces.
Recruitment status was:  Recruiting
First Posted : June 10, 2013
Last Update Posted : June 10, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injury Procedure: cell therapy Other: rehabilitation Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : June 2012
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
Other: rehabilitation
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.


Outcome Measures

Primary Outcome Measures :
  1. Neurological Function Score(ASIA and Barthel Index) [ Time Frame: Change from baseline at 12 monthes after enrollment or transplantation ]

Secondary Outcome Measures :
  1. Electromyogram and Electroneurophysiologic Test [ Time Frame: Change from baseline at 12 monthes after enrollment or transplantation ]
  2. Blood Test [ Time Frame: Change from baseline at 12 monthes after enrollment or transplantation ]
    1. red blood cell
    2. white blood cell
    3. platelet count
    4. alanine aminotransferase
    5. aspartate aminotransferase
    6. total bilirubin
    7. albumin


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients or their curator must be able to give voluntary consent.
  2. Patients have clear history of traumatic injury.
  3. 20 years - 65 years of age can be enrolled.
  4. Both male and female can be enrolled.
  5. The diagnosis of spinal cord injury are confirmed by all of the examinations including MRI, electromyogram and electrophysiology.
  6. The time of injury was longer than 1 year.

Exclusion Criteria:

  1. Mental disorders
  2. Myelitis
  3. Women in pregnancy
  4. Cancer
Contacts and Locations

Information from the National Library of Medicine

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): NCT01873547


Contacts
Contact: Yihua An, Ph D 0086-10-57976848 doctoran2010@hotmail.com
Contact: Yihua An, Ph D 0086-10-57976848

Locations
China, Beijing
General Hospital of Chinese People's Armed Police Forces Recruiting
Beijing, Beijing, China, 100050
Contact: Yihua An, Ph D    0086-10-57976848    doctoran2010@hotmail.com   
Contact: Rongrong Hua    0086-10-57976866    huarongrong1011@163.com   
Principal Investigator: Yihua An, Ph D         
Sponsors and Collaborators
General Hospital of Chinese Armed Police Forces
Investigators
Study Director: Yihua An, Ph.D the General Hospital of Chinese People's Armed Police Forces
More Information

Responsible Party: General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier: NCT01873547     History of Changes
Other Study ID Numbers: 2013-03-04SCI-III
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: June 10, 2013
Last Verified: June 2013

Keywords provided by General Hospital of Chinese Armed Police Forces:
spinal cord injury
cell transplantation
rehabilitation

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries