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

NCT04849429 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-08-02

No results posted yet for this study

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

Conditions

  • Chronic Low Back Pain
  • Degenerative Disc Disease

Interventions

BIOLOGICAL

Platelet rich plasma (PRP) with exosomes

Autologous Platelet rich plasma (PRP) with exosomes Following skin disinfection of the back 2 ml from the total PRPex procured will be injected as soon as possible by an fluoroscopy guided lateral approach.

DRUG

Normal Saline

placebo : 2 ml normal saline para discal administration

Sponsors & Collaborators

  • Dr. Himanshu Bansal Foundation

    lead OTHER

Principal Investigators

  • HIMANSHU BANSAL, MS · HIMANSHU BANSAL FOUNDATION

  • JEREMY PONT, Mchiro · PHOENIX HELSE Norway

  • DAVID WILSON, MBBS · PHOENIX HELSE Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04849429 on ClinicalTrials.gov