Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Lumbar Intervertebral Disc Degeneration
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01643681|
Recruitment Status : Withdrawn (No longer willing to continue clinical trials)
First Posted : July 18, 2012
Last Update Posted : June 5, 2019
|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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
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
|Korea, Republic of|
|Korea University Anam Hospital|
|Seoul, Korea, Republic of|