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

NCT ID: NCT01393977

Last Updated: 2011-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-05-31

Brief Summary

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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

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

Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control

Outpatient in hospital

Group Type NO_INTERVENTION

No interventions assigned to this group

rehabilitation

interventions: rehabilitation

Group Type ACTIVE_COMPARATOR

rehabilitation of limb function

Intervention Type PROCEDURE

only receive rehabilitation of limb function

Stem Cell Transplantation

interventions: stem cell transplantation

Group Type EXPERIMENTAL

Stem Cells Transplantation

Intervention Type PROCEDURE

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

Interventions

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rehabilitation of limb function

only receive rehabilitation of limb function

Intervention Type PROCEDURE

Stem Cells Transplantation

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

Intervention Type PROCEDURE

Other Intervention Names

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phsical exercise rehabilitation

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Chinese Armed Police Forces

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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An Yihua, doctor

Role: STUDY_DIRECTOR

Chinese People's Armed Police Force

Locations

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Yihua An

Beijing, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Yihua An, doctor

Role: primary

[email protected]
0086-10-88276848

References

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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.

Reference Type DERIVED
PMID: 25209445 (View on PubMed)

Other Identifiers

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2011-01-19SCI

Identifier Type: -

Identifier Source: org_study_id