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
  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

Resource links provided by NLM:


Further study details as provided by General Hospital of Chinese Armed Police Forces:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393977

Locations
China
Yihua An Recruiting
Beijing, China
Contact: Yihua An, doctor    0086-10-88276848    doctoran2010@hotmail.com   
Sponsors and Collaborators
General Hospital of Chinese Armed Police Forces
Investigators
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
Wounds and 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

ClinicalTrials.gov processed this record on July 23, 2014