CTRI/2024/07/069696
Recruiting
Phase 1
A Phase I clinical trial to examine the safety and efficacy of autologous, cultured disc chondrocytes embedded in PRF transplanted in patients disc to maintain its function. - IndiSK
Samarthakrupa LIfesciences Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Health Condition 1: M511- Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy
- Sponsor
- Samarthakrupa LIfesciences Pvt Ltd
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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