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 : Unknown
Verified March 2014 by Biostar.
Recruitment status was: Recruiting
First Posted : July 18, 2012
Last Update Posted : March 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Lumbar Intervertebral Disc Degeneration||Procedure: Autologous Adipose Tissue derived MSCs Transplantation||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 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|
|Estimated Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||April 2014|
Procedure: Autologous Adipose Tissue derived MSCs Transplantation
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643681
|Contact: Tai-Hyoung Cho, M.D. & Ph.D.||firstname.lastname@example.org|
|Korea, Republic of|
|Korea University Anam Hospital||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Tai-Hyoung Cho, M.D. & Ph.D. 82-10-3791-5338 email@example.com|
|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.|