Clinical trial NCT01873547: Different Efficacy Between Rehabilitation Therapy and Stem Cells Transplantation in Patients With SCI in China
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
cell transplantation
rehabilitation
Lead sponsor: General Hospital of Chinese Armed Police Forces
Sponsor class: OTHER
First posted: 2013-06-10
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cell therapy or rehabitation treatment
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Assessment of changes in International Standards for Neurological Classification of Spinal Cord Injury according to American Spine Injury Association
timeFrame: Baseline, 6 and 12 months after recruitment
Secondary outcomes:
measure: Assessment of changes in score of pain index using Short-form McGill Pain Questionnaire
timeFrame: Baseline,6 and 12 months after recruitment
measure: Assessment of changes in score of activity of daily living
timeFrame: Baseline, 6 and 12 months after recruitment
measure: Assessment of changes in sensory evoked potentials and motor evoked potentials
timeFrame: Baseline,6 and 12 months after recruitment
Other outcomes:
Locations:
city: Beijing
country: China
facility: General Hospital of Chinese People's Armed Police Forces
state: Beijing
Study officials:
affiliation: the General Hospital of Chinese People's Armed Police Forces
name: Yihua An, Ph.D
role: STUDY_DIRECTOR
References: