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Clinical Trials/NCT01643681
NCT01643681
Withdrawn
Not Applicable

Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Lumbar Intervertebral Disc Degeneration

R-Bio1 site in 1 countryJuly 2012
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ConditionsLumbar Intervertebral Disc Degeneration

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lumbar Intervertebral Disc Degeneration
Sponsor
R-Bio
Locations
1
Primary Endpoint
Magnetic Resonance Imaging
Status
Withdrawn
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
December 2015
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
R-Bio
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Magnetic Resonance Imaging

Time Frame: 24 weeks

To evaluate the change of treated lumbar intervertebral discs using Magnetic Resonance Imaging (MRI) at 6 months post injection of MSCs.

Secondary Outcomes

  • Changes of Neurological Functions(24 weeks)
  • Safety evaluation(24 weeks)

Study Sites (1)

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