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

Phase 2

• Conditions: Spinal Cord Injuries
• Interventions: Procedure: rehabilitation of limb function; Procedure: Stem Cells Transplantation

• Registration Number: NCT01393977
• Lead Sponsor: General Hospital of Chinese Armed Police Forces

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-07-06
• Study First Submitted QC: 2011-07-12
• Study First Posted: 2011-07-14
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-07
• Last Update Posted: 2011-10-10
• Primary Completion: 2011-12
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
rehabilitation	rehabilitation of limb function	interventions: rehabilitation
Stem Cell Transplantation	Stem Cells Transplantation	interventions: stem cell transplantation

Primary Outcome Measures

Name	Time	Method
Electromyogram and Electroneurophysiologic test	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.

Secondary Outcome Measures

Name	Time	Method
Electromyogram and Electroneurophysiologic test	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.

Trial Locations

Locations (1)

Yihua An; 🇨🇳 Beijing, China