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

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ClinicalTrials.gov Identifier: NCT01643681
Recruitment Status : Withdrawn (No longer willing to continue clinical trials)
First Posted : July 18, 2012
Last Update Posted : April 26, 2018
Sponsor:
Collaborator:
Korea University Anam Hospital
Information provided by (Responsible Party):
Biostar

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.

Condition or disease Intervention/treatment Phase
Lumbar Intervertebral Disc Degeneration Procedure: Autologous Adipose Tissue derived MSCs Transplantation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: AdMSC
Autologous Adipose Tissue derived Mesenchymal Stem Cells
Procedure: Autologous Adipose Tissue derived MSCs Transplantation
Into lumbar intervertebral disc infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 4x10e7 cells/1mL



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Changes of Neurological Functions [ Time Frame: 24 weeks ]
    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.

  2. Safety evaluation [ Time Frame: 24 weeks ]
    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.



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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643681


Locations
Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Biostar
Korea University Anam Hospital

Responsible Party: Biostar
ClinicalTrials.gov Identifier: NCT01643681     History of Changes
Other Study ID Numbers: KSC-MSCs-LIDD
First Posted: July 18, 2012    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018

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