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

General Hospital of Chinese Armed Police Forces

Status and phase: Unknown; Phase 2

Conditions: Spinal Cord Injuries

Treatments: Procedure: rehabilitation of limb function; Procedure: Stem Cells Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01393977

2011-01-19SCI

Details and patient eligibility

About

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.

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: 60 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

60 participants in 3 patient groups

control

No Intervention group

Description:

Outpatient in hospital

rehabilitation

Active Comparator group

Description:

interventions: rehabilitation

Treatment:

Procedure: rehabilitation of limb function

Stem Cell Transplantation

Experimental group

Description:

interventions: stem cell transplantation

Treatment:

Procedure: Stem Cells Transplantation