Health Condition 1: M511- Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy
Conditions
Interventions
Intervention1: IndiSK: Single dose of approximately 1x106 autologous cells (in saline)
Route of administration - Intervertebral Disc Space
Duration of intervention- 1 year
Control Intervention1: NA:
Sponsors
Samarthakrupa LIfesciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients undergoing discectomy for symptomatic disc herniation with radiculopathy 2. Patients undergoing intervertebral fusion surgery with adjacent level degeneration 3. Adult population (18-70 years of age) 4. Mentally and physically fit to participate in the trial 5. Informed consent with willingness to follow up for clinical, laboratory and imaging studies.
Exclusion criteria
Exclusion criteria: 1. Significant neurological deficit 2. Other neurological diseases (e.g., Motor neuron disease, Parkinson’s disease, Poliomyelitis) 3. Spondylolisthesis/instability 4. Collapsed disc space less than 10 mms in height 5. Calcified/Hard disc or osteophytes bridging the disc space 6. Seropositive for HIV, Hepatitis B or C 7. Patients psychologically and medically unfit for transplantation 8. Inflammatory diseases such as Rheumatoid arthritis, Seronegative Spondyloarthropathy, Ulcerative colitis, Crohn’s disease 9. Autoimmune disorders such as Haemolytic anaemia 10. Steroid intake present or in the past within last 3 years for more than 3 months 11. Active systemic infection or present or past history of local infection 12. Local vertebral fractures present or in the past if it is causing significant sagittal deformity in standing radiograph of the spine 13. Local or systemic malignancy 14. Previous history of spondylodiscitis 15. Claustrophobic patients non cooperative for MRI evaluation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No inflammation at the site of injection, anaphylactic reaction, neurological deficit, elevation of serum markers, or worsening of pain. No increase in stiffness, no change in alignment of the spine, no reduction in the nerve root mobility, no reduction in the distance covered in a ten minute walk test pre and post implantation.Timepoint: 1, 6, 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| ? Improvement in self-assessment scores (modified ODI, RMDQ & VAS) in comparison to pre-implantation scores. ? MRI shows better hydration compared to the pre-surgery MRI. Timepoint: 6, 12 months | — |
Countries
India
Contacts
Public ContactDivya C
Samarthakrupa Lifesciences Pvt Ltd
Outcome results
None listed