Cell Therapy for back pai
- Conditions
- Health Condition 1: M511- Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy
- Registration Number
- CTRI/2024/07/069696
- Lead Sponsor
- Samarthakrupa LIfesciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method o 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 Outcome Measures
Name Time Method ?Improvement in self-assessment scores (modified ODI, RMDQ & VAS) in comparison to pre-implantation scores. <br/ ><br> ?MRI shows better hydration compared to the pre-surgery MRI. <br/ ><br>Timepoint: 6, 12 months