drugset / Trial / NCT04849429

Intra-discal Injection of Platelet-rich Plasma (PRP) Enriched With Exosomes in Chronic Low Back Pain

NCT04849429 ↗

Phase 1 Completed 30 enrolled Dr. Himanshu Bansal Foundation
RandomizedParallel-groupTriple-blindTreatment

Summary

Intervertebral disc pathology accounts for 40% or more cases of chronic LBP. Available treatment options do not improve the underlying degenerative condition hence This indicates the need for new therapies. intradiscal injection of PRP with exosomes derived from blood may potentially transmit some of the unique stem cell properties to other stem cells, facilitating stemness maintenance, differentiation, self-renewal, and repair. controlled, randomized, double-blind placebo clinical trial to compare the safety and efficacy of PRP with exosomes in discogenic LBP adminstartion of PRP with exosomes at the centre of the nucleus pulposus or equal amount of placebo paradiscal patients wil be elvaluated for primary Outcome measures viz: Visual analog scale (VAS), Roland Morris Disability Questionnaire (RDQ), SF 36 health questionnaire, Functional rating index and Secondary: MRI - disc degeneration grading, T2 quantification, and for any Adverse events including of discitis

Timeline

Start
2021-09-10
Primary completion
2022-06-18
Completion
2022-07-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Platelet rich plasma (PRP) with exosomes Unknown 2 ml Other