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

• Status: Completed
• Trial end date: 2022-07-25
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dr. Himanshu Bansal Foundation

Criteria

Inclusion Criteria:

1. Age between18 Years to 60 Years of any sex 2. Written and signed informed consent form

3. Chronic low back pain without leg pain for more than 3 months. 2. Symptomatic moderate to severe discogenic low back pain as defined according to the following criteria: centralized chronic low back that increased with activity and lasted at least six months.

3. Failure of conservative treatment measures (oral medications, rehabilitation therapy, and/or injection therapy) 4. Evidence of degeneration, as indicated via magnetic resonance imaging (MRI) decreased signal intensity on T2.

5. MRI Pfirrmann (MRI) score 3-6 6. Modic Grade II change or less 7. Disk protrusion less than 5 mm on magnetic resonance imaging maintenance of 50% or more of normal disc height. An intact annulus is not required 8. Subjects must be able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria:

1. Spinal stenosis

2. An abnormal neurologic exam

3. Symptomatic compressive pathology

4. A disc herniation causing significant compression with neurologic deficit.

5. Extrusions or sequestered disk fragments

6. Any spondylolisthesis or spondylolysis.

7. Presence of a grade 5 annular fissure on discography