Different Efficacy Between Rehabilitation Therapy and Stem Cells Transplantation in Patients With SCI in China

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Spinal Cord Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

cell therapy or rehabitation treatment

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

rehabilitation

Intervention Type OTHER

Patients only receive rehabilitation of limb function.

cell therapy

Patients in the group accept cell therapy including four times stem cells transplant via intrathecal injection.

Group Type EXPERIMENTAL

cell therapy

Intervention Type BIOLOGICAL

Mesenchymal stem cells derived from umbilical cord are transplanted directly into subarachnoid by Lumbar puncture.

control

Patients receive no professional treatment in hospital or rehabilitation centre.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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cell therapy

Mesenchymal stem cells derived from umbilical cord are transplanted directly into subarachnoid by Lumbar puncture.

Intervention Type BIOLOGICAL

rehabilitation

Patients only receive rehabilitation of limb function.

Intervention Type OTHER

Other Intervention Names

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physical exercise rehabilitation

Eligibility Criteria

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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.