Intra-discal Injection of Platelet-rich Plasma (PRP) Enriched With Exosomes in Chronic Low Back Pain
CompletedPhase 1NCT04849429
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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
Study details
- Official title
- A Randomized, Double-blind Controlled Trial of the Efficacy of an Intra-discal Injection of Autologous Platelet-rich Plasma (PRP) Enriched With Exosomes (PRPex) Versus Placebo in Chronic Low Back Pain
- Interventions
- Biological: Platelet rich plasma (PRP) with exosomes
- Drug: Normal Saline
- Sponsor
- Dr. Himanshu Bansal Foundation
- Start date
- 2021-09-10
- Primary completion
- 2022-06-18
- Sex
- All
- Age range
- from 18 Years to 60 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- India
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04849429