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

NCT04849429 | Completed Phase 1 DMC

• 1 other identifier: HB/CLINICALTRIAL/01/2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

intra-discal PRPEx Chronic Low Back Pain

Outcome Measures

Primary Outcomes (4)

• Visual analog scale (VAS)

  The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. Change in VAS score will be assessed.

  Change from Baseline VAS at 1,3, 6,12 months

• Roland Morris Disability Questionnaire (RDQ)

  The Roland-Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability)

  Change from Baseline RDQ at 1,3,6,12 months

• SF 36 health questionnaire

  The SF.36 questionnaire (SF-36) contains 36 items that assess patients' health status and its impact on their lives. It comprises 36 questions which cover eight domains of health 1. Limitations in physical activities because of health problems. 2. Limitations in social activities because of physical or emotional problems 3. Limitations in usual role activities because of physical health problems 4. Bodily pain 5. General mental health (psychological distress and well-being) 6. Limitations in usual role activities because of emotional problems 7. Vitality (energy and fatigue) 8. General health perceptions. Change in SF 36 will be assessed.

  Change from Baseline SF 36 at 1,3,6,12 months

• Functional rating index

  The Functional Rating Index (FRI) is an instrument specifically designed to quantitatively measure the subjective perception of function and pain of the spinal musculoskeletal system. Change will be assessed.

  Change from Baseline Functional rating index at 1,3,6,12 months

Secondary Outcomes (1)

• MRI

  Changes from baseline MRI findings will be assesed at 12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo (trigger point injection under C-arm)

Drug: Normal Saline

Platelet rich plasma (PRP) with exosomes

EXPERIMENTAL

PRP with exosomes at the center of the nucleus pulposus (2ml)

Biological: Platelet rich plasma (PRP) with exosomes

Interventions

Platelet rich plasma (PRP) with exosomes BIOLOGICAL

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.

Platelet rich plasma (PRP) with exosomes

Normal Saline DRUG

placebo : 2 ml normal saline para discal administration

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.
• \. 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.
• \. 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

You may not qualify if:

• Spinal stenosis
• An abnormal neurologic exam
• Symptomatic compressive pathology
• A disc herniation causing significant compression with neurologic deficit.
• Extrusions or sequestered disk fragments
• Any spondylolisthesis or spondylolysis.
• Presence of a grade 5 annular fissure on discography

Sponsors & Collaborators

• Dr. Himanshu Bansal Foundation: lead

Study Sites (2)

Anupam Hospital

Rudrapur, Uttarakhand, 263153, India

Location

Mother Cell Spinal Injury and Stem Cell Research, Anupam Hospital

Rudrapur, Uttarakhand, 263153, India

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• HIMANSHU BANSAL, MS

  HIMANSHU BANSAL FOUNDATION

  PRINCIPAL INVESTIGATOR

• JEREMY PONT, Mchiro

  PHOENIX HELSE Norway

  PRINCIPAL INVESTIGATOR

• DAVID WILSON, MBBS

  PHOENIX HELSE Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomly selected based on computer generated number to receive one undistinguishable injection of PRP ex or placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 1. Arm I will be assigned to receive placebo (trigger point injection under carm) 2. Arm II: to receive PRP with exosomes at the center of the nucleus pulposus (2ml)

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 19, 2021
• Study Start: September 10, 2021
• Primary Completion: June 18, 2022
• Study Completion: July 25, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: ANYTIME
• Access Criteria: ANYONE INTERESTED TO CRITICALLY EVALUATE OR REPRODUCE

Locations

IN (2)