NCT01393977

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

October 10, 2011

Status Verified

October 1, 2011

Enrollment Period

11 months

First QC Date

July 6, 2011

Last Update Submit

October 7, 2011

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord InjuriesStem Cell TransplantationRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Electromyogram and Electroneurophysiologic test

    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 Outcomes (2)

  • Electromyogram and Electroneurophysiologic test

    6monthes after enrollment or transplantation

  • Electromyogram and Electroneurophysiologic test

    12monthes after enrollment or transplantation

Study Arms (3)

control

NO INTERVENTION

Outpatient in hospital

rehabilitation

ACTIVE COMPARATOR

interventions: rehabilitation

Procedure: rehabilitation of limb function

Stem Cell Transplantation

EXPERIMENTAL

interventions: stem cell transplantation

Procedure: Stem Cells Transplantation

Interventions

rehabilitation of limb functionPROCEDURE

only receive rehabilitation of limb function

Also known as: phsical exercise rehabilitation
rehabilitation
Stem Cells TransplantationPROCEDURE

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

Stem Cell Transplantation

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • Mental disorders
  • Myelitis
  • Women in pregnancy
  • Cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yihua An

Beijing, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 25209445DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Cell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • An Yihua, doctor

    Chinese People's Armed Police Force

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2011

First Posted

July 14, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2011

Study Completion

May 1, 2012

Last Updated

October 10, 2011

Record last verified: 2011-10

Locations

CN(1)