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 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

暂无简介。

•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

发起方

Samarthakrupa LIfesciences Pvt Ltd