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

October 7, 2011 updated by: General Hospital of Chinese Armed Police Forces

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Yihua An

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
Outpatient in hospital
Active Comparator: rehabilitation
interventions: rehabilitation
Procedure: rehabilitation of limb function
only receive rehabilitation of limb function
Other Names:
  • phsical exercise rehabilitation
Experimental: Stem Cell Transplantation
interventions: stem cell transplantation
Procedure: Stem Cells Transplantation
mesenchymal stem cells derived from umbilical cord are transplanted directly into subarachnoid by Lumbar puncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electromyogram and Electroneurophysiologic test
Time Frame: 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.
3 monthes after enrollment or transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electromyogram and Electroneurophysiologic test
Time Frame: 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.
6monthes after enrollment or transplantation
Electromyogram and Electroneurophysiologic test
Time Frame: 12monthes after enrollment or transplantation
Brain stem auditory evoked potential (BAEP)and electromyography can display the nerve conduction velocity and the improvement of neurological function.
12monthes after enrollment or transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital of Chinese Armed Police Forces

Investigators

  • Study Director: An Yihua, doctor, Chinese People's Armed Police Force

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

July 6, 2011

First Submitted That Met QC Criteria

July 12, 2011

First Posted (Estimate)

July 14, 2011

Study Record Updates

Last Update Posted (Estimate)

October 10, 2011

Last Update Submitted That Met QC Criteria

October 7, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-01-19SCI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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