Lumbar Intervertebral Disc Degeneration Clinical Trial
Official title:
Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Lumbar Intervertebral Disc Degeneration
| NCT number | NCT01643681 |
| Other study ID # | KSC-MSCs-LIDD |
| Secondary ID | |
| Status | Withdrawn |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 2012 |
| Est. completion date | December 2015 |
| Verified date | June 2019 |
| Source | R-Bio |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | December 2015 |
| Est. primary completion date | March 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years to 70 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Korea University Anam Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| R-Bio | Korea University Anam Hospital |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Magnetic Resonance Imaging | To evaluate the change of treated lumbar intervertebral discs using Magnetic Resonance Imaging (MRI) at 6 months post injection of MSCs. | 24 weeks | |
| Secondary | Changes of Neurological Functions | 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. | 24 weeks | |
| Secondary | Safety evaluation | 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. | 24 weeks |