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

NCT01873547 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2018-05-25

No results posted yet for this study

Summary

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.

Conditions

  • Spinal Cord Injury

Interventions

BIOLOGICAL

cell therapy

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

OTHER

rehabilitation

Patients only receive rehabilitation of limb function.

Sponsors & Collaborators

  • General Hospital of Chinese Armed Police Forces

    lead OTHER

Principal Investigators

  • Yihua An, Ph.D · the General Hospital of Chinese People's Armed Police Forces

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-10-31
Completion
2015-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01873547 on ClinicalTrials.gov