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

Efficacy Difference Between Rehabilitation Therapy and Umbilical Cord Derived Mesenchymal Stem Cells Transplantation in Patients With Acute or Chronic Spinal Cord Injury in China

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01393977

Enrollment

Registered

2011-07-14

Start date

2011-01-31

Completion date

2012-05-31

Last updated

2011-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injuries, Stem Cell Transplantation, Rehabilitation

Brief summary

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.

Detailed description

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

Interventions

PROCEDURErehabilitation of limb function

only receive rehabilitation of limb function

PROCEDUREStem Cells Transplantation

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Electromyogram and Electroneurophysiologic test	3 monthes after enrollment or transplantation	Brain stem auditory evoked potential (BAEP)and electromyography can display the nerve conduction velocity and the improvement of neurological function.

Secondary

Measure	Time frame	Description
Electromyogram and Electroneurophysiologic test	6monthes after enrollment or transplantation	Brain stem auditory evoked potential (BAEP)and electromyography can display the nerve conduction velocity and the improvement of neurological function.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026