search
Back to results

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

Primary Purpose

Spinal Cord Injuries

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
rehabilitation of limb function
Stem Cells Transplantation
Sponsored by
General Hospital of Chinese Armed Police Forces
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal Cord Injuries, Stem Cell Transplantation, Rehabilitation

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Yihua AnRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

control

rehabilitation

Stem Cell Transplantation

Arm Description

Outpatient in hospital

interventions: rehabilitation

interventions: stem cell transplantation

Outcomes

Primary Outcome Measures

Electromyogram and Electroneurophysiologic test
Brain stem auditory evoked potential (BAEP)and electromyography can display the nerve conduction velocity and the improvement of neurological function.

Secondary Outcome Measures

Electromyogram and Electroneurophysiologic test
Brain stem auditory evoked potential (BAEP)and electromyography can display the nerve conduction velocity and the improvement of neurological function.
Electromyogram and Electroneurophysiologic test
Brain stem auditory evoked potential (BAEP)and electromyography can display the nerve conduction velocity and the improvement of neurological function.

Full Information

First Posted
July 6, 2011
Last Updated
October 7, 2011
Sponsor
General Hospital of Chinese Armed Police Forces
search

1. Study Identification

Unique Protocol Identification Number
NCT01393977
Brief Title
Difference Between Rehabilitation Therapy and Stem Cells Transplantation in Patients With Spinal Cord Injury in China
Official Title
Efficacy Difference Between Rehabilitation Therapy and Umbilical Cord Derived Mesenchymal Stem Cells Transplantation in Patients With Acute or Chronic Spinal Cord Injury in China
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
May 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
General Hospital of Chinese Armed Police Forces

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Spinal Cord Injuries, Stem Cell Transplantation, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Description
Outpatient in hospital
Arm Title
rehabilitation
Arm Type
Active Comparator
Arm Description
interventions: rehabilitation
Arm Title
Stem Cell Transplantation
Arm Type
Experimental
Arm Description
interventions: stem cell transplantation
Intervention Type
Procedure
Intervention Name(s)
rehabilitation of limb function
Other Intervention Name(s)
phsical exercise rehabilitation
Intervention Description
only receive rehabilitation of limb function
Intervention Type
Procedure
Intervention Name(s)
Stem Cells Transplantation
Intervention Description
mesenchymal stem cells derived from umbilical cord are transplanted directly into subarachnoid by Lumbar puncture
Primary Outcome Measure Information:
Title
Electromyogram and Electroneurophysiologic test
Description
Brain stem auditory evoked potential (BAEP)and electromyography can display the nerve conduction velocity and the improvement of neurological function.
Time Frame
3 monthes after enrollment or transplantation
Secondary Outcome Measure Information:
Title
Electromyogram and Electroneurophysiologic test
Description
Brain stem auditory evoked potential (BAEP)and electromyography can display the nerve conduction velocity and the improvement of neurological function.
Time Frame
6monthes after enrollment or transplantation
Title
Electromyogram and Electroneurophysiologic test
Description
Brain stem auditory evoked potential (BAEP)and electromyography can display the nerve conduction velocity and the improvement of neurological function.
Time Frame
12monthes after enrollment or transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients or their curator must be able to give voluntary consent. Patients or their curator Must be able to understand the information of study and in which group they are. 20 years - 50 years of age can be enrolled. Both male and female can be enrolled. 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: Mental disorders Myelitis Women in pregnancy Cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
An Yihua, doctor
Organizational Affiliation
Chinese People's Armed Police Force
Official's Role
Study Director
Facility Information:
Facility Name
Yihua An
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yihua An, doctor
Phone
0086-10-88276848
Email
doctoran2010@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
25209445
Citation
Cheng H, Liu X, Hua R, Dai G, Wang X, Gao J, An Y. Clinical observation of umbilical cord mesenchymal stem cell transplantation in treatment for sequelae of thoracolumbar spinal cord injury. J Transl Med. 2014 Sep 12;12:253. doi: 10.1186/s12967-014-0253-7.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs