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

This study is currently recruiting participants.
Verified July 2012 by RNL Bio Company Ltd.
Sponsor:
Collaborator:
Korea University Anam Hospital
Information provided by (Responsible Party):
RNL Bio Company Ltd.
ClinicalTrials.gov Identifier:
NCT01643681
First received: July 16, 2012
Last updated: July 17, 2012
Last verified: July 2012
History of Changes

July 16, 2012
July 17, 2012
July 2012
March 2013   (final data collection date for primary outcome measure)
Magnetic Resonance Imaging [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To evaluate the change of treated lumbar intervertebral discs using Magnetic Resonance Imaging (MRI) at 6 months post injection of MSCs.
Same as current
Complete list of historical versions of study NCT01643681 on ClinicalTrials.gov Archive Site
  • Changes of Neurological Functions [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    To evaluate the change of treated lumbar intervertebral discs using Muscle Test, Somatosensory Test, Deep Tendon Reflex and VAS (Visual Analogue Scale Score 0-10) at 6 months post injection of MSCs.
  • Safety evaluation [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests.
Same as current
Not Provided
Not Provided
 
Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Lumbar Intervertebral Disc Degeneration
Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Lumbar Intervertebral Disc Degeneration

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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lumbar Intervertebral Disc Degeneration
Procedure: Autologous Adipose Tissue derived MSCs Transplantation
Into lumbar intervertebral disc infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 4x10e7 cells/1mL
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
8
April 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
19 Years to 70 Years
No
Contact: Tai-Hyoung Cho, M.D. & Ph.D. 82-10-3791-5338 choth2@korea.ac.kr
Korea, Republic of
 
NCT01643681
RB-MSCs-LIDD
No
RNL Bio Company Ltd.
RNL Bio Company Ltd.
Korea University Anam Hospital
Not Provided
RNL Bio Company Ltd.
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP