Different Efficacy Between Rehabilitation Therapy and Stem Cells Transplantation in Patients With SCI in China (SCI-III)

General Hospital of Chinese Armed Police Forces

Status and phase: Completed; Phase 3

Conditions: Spinal Cord Injury

Treatments: Other: rehabilitation; Biological: cell therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01873547

2013-03-04SCI-III

Details and patient eligibility

About

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.

Full description

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

Enrollment: 300 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 3 patient groups

rehabilitation

Active Comparator group

Description:

Patients in the group accept rehabilitation for three weeks in hospital and other eleven months in their home under the guidance of physical therapist.

Treatment:

Other: rehabilitation

cell therapy

Experimental group

Description:

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

Treatment:

Biological: cell therapy

control

No Intervention group

Description:

Patients receive no professional treatment in hospital or rehabilitation centre.