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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
  Purpose

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.


Condition Intervention Phase
Lumbar Intervertebral Disc Degeneration
 Procedure: Autologous Adipose Tissue derived MSCs Transplantation
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Lumbar Intervertebral Disc Degeneration

Further study details as provided by RNL Bio Company Ltd.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 8
Study Start Date: July 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Autologous Adipose Tissue derived MSCs Transplantation
    Into lumbar intervertebral disc infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 4x10e7 cells/1mL
  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643681

Contacts
Contact: Tai-Hyoung Cho, M.D. & Ph.D. 82-10-3791-5338 choth2@korea.ac.kr

Locations
Korea, Republic of
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Contact: Tai-Hyoung Cho, M.D. & Ph.D.     82-10-3791-5338     choth2@korea.ac.kr    
Principal Investigator: Tai-Hyoung Cho, M.D. & Ph.D.            
Sub-Investigator: Dong-Hyuk Park, M.D. & Ph.D.            
Sub-Investigator: Jang-Bo Lee, M.D. & Ph.D.            
Sub-Investigator: Sang-Heon Lee, M.D. & Ph.D.            
Sponsors and Collaborators
RNL Bio Company Ltd.
Korea University Anam Hospital
  More Information

No publications provided

Responsible Party: RNL Bio Company Ltd.
ClinicalTrials.gov Identifier: NCT01643681     History of Changes
Other Study ID Numbers: RB-MSCs-LIDD
Study First Received: July 16, 2012
Last Updated: July 17, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Intervertebral Disk Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 21, 2013