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

Spinal Cord Injuries Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01393977
• Other study ID #: 2011-01-19SCI
• Status: Unknown status
• Phase: Phase 2
• First received: July 6, 2011
• Last updated: October 7, 2011
• Start date: January 2011
• Est. completion date: May 2012

Study information

• Verified date: October 2011
• Source: General Hospital of Chinese Armed Police Forces
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 60
• Est. completion date: May 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Procedure:
• rehabilitation of limb function
only receive rehabilitation of limb function
• Stem Cells Transplantation
mesenchymal stem cells derived from umbilical cord are transplanted directly into subarachnoid by Lumbar puncture

Locations

Country	Name	City	State
China	Yihua An	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Chinese Armed Police Forces

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electromyogram and Electroneurophysiologic test	Brain stem auditory evoked potential (BAEP)and electromyography can display the nerve conduction velocity and the improvement of neurological function.	3 monthes after enrollment or transplantation
Secondary	Electromyogram and Electroneurophysiologic test	Brain stem auditory evoked potential (BAEP)and electromyography can display the nerve conduction velocity and the improvement of neurological function.	6monthes after enrollment or transplantation
Secondary	Electromyogram and Electroneurophysiologic test	Brain stem auditory evoked potential (BAEP)and electromyography can display the nerve conduction velocity and the improvement of neurological function.	12monthes after enrollment or transplantation