Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Lumbar Intervertebral Disc Degeneration

NCT ID: NCT01643681

Last Updated: 2019-06-05

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with lumbar intervertebral disc degeneration.

Detailed Description

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Conditions

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Lumbar Intervertebral Disc Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AdMSC

Autologous Adipose Tissue derived Mesenchymal Stem Cells

Group Type EXPERIMENTAL

Autologous Adipose Tissue derived MSCs Transplantation

Intervention Type PROCEDURE

Into lumbar intervertebral disc infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 4x10e7 cells/1mL

Interventions

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Autologous Adipose Tissue derived MSCs Transplantation

Into lumbar intervertebral disc infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 4x10e7 cells/1mL

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Subjects who understand and sign the consent form for this study
* Age :19-70, males and females
* Have chronic low back pain for at least 1 year
* Have failed 1 year of non-operative low back pain management
* Have degenerated intervertebral disc on T2-weighted MR images
* confirmed by positive discography
* Have significant lumbar instability at degenerated intervertebral disc

Exclusion Criteria

* Have significant lumbar herniated intervertebral disc
* Women who are pregnant or breast feeding or planning to become pregnant during the study
* History or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications
* Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases, Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus
* Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study
* Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea University Anam Hospital

OTHER

Sponsor Role collaborator

R-Bio

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Korea University Anam Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KSC-MSCs-LIDD

Identifier Type: -

Identifier Source: org_study_id

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