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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Biostar

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: Biostar

Dates:
Date Received: July 16, 2012
Date Started: July 2012
Date Completion: April 2014
Last Updated: March 24, 2014
Last Verified: March 2014