Lumbar Intervertebral Disc Degeneration
Conditions
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.
Interventions
Into lumbar intervertebral disc infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 4x10e7 cells/1mL
Sponsors
Korea University Anam Hospital
R-Bio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed