Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Lumbar Intervertebral Disc Degeneration
- Conditions
- Lumbar Intervertebral Disc Degeneration
- Interventions
- Procedure: Autologous Adipose Tissue derived MSCs Transplantation
- Registration Number
- NCT01643681
- Lead Sponsor
- R-Bio
- 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 Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AdMSC Autologous Adipose Tissue derived MSCs Transplantation Autologous Adipose Tissue derived Mesenchymal Stem Cells
- Primary Outcome Measures
Name Time Method Magnetic Resonance Imaging 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
Name Time Method Changes of Neurological Functions 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 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.
Trial Locations
- Locations (1)
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of