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

G

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

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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