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

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ClinicalTrials.gov Identifier: NCT04849429
Recruitment Status : Recruiting
First Posted : April 19, 2021
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
anupama agrawal, Dr. Himanshu Bansal Foundation

Brief Summary:

Management of chronic low back pain (LBP) has contributed to its high socioeconomic burden. The intervertebral disc accounts for 40% or more cases of chronic LBP. Available treatment options do not improve the underlying degenerative condition, although they do resolve its symptoms. This indicates the need for new therapies and/or interventions that actually treat the underlying causes of discogenic pain. Biological therapies by direct injection of PRP into the annulus fibrosus and nucleus pulposus seems an effective and feasible option.

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. We propose to have a controlled, randomized, double-blind clinical trial to compare the safety and efficacy of exosomes in LBP. Informed consent will be obtained from all subjects prior to study participation. Patients will be randomized into 2 arms with either to receive PRP with exosomes at the centre of the nucleus pulposus or equal amount of placebo and will be evaluated by 2 interventional spine and medicine physicians.

Outcome measures Primary Visual analog scale (VAS), Roland Morris Disability Questionnaire (RDQ), SF 36 health questionnaire, Functional rating index Secondary: MRI - disc degeneration grading, T2 quantification, Adverse events any evidence of discitis or discontinuation , worsening of pain will be deeply analyzed.

Monitoring visits will be conducted according to standard monitoring procedures. Differences in paired samples will be compared using the two-tailed Student's t-test. All routine monitoring functions will be performed prior to the study termination visit.


Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Degenerative Disc Disease Biological: Platelet rich plasma (PRP) with exosomes Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  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)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Patients will be randomly selected based on computer generated number to receive one undistinguishable injection of PRP ex or placebo.
Primary Purpose: Treatment
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
Estimated Study Start Date : April 15, 2021
Estimated Primary Completion Date : March 15, 2022
Estimated Study Completion Date : March 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo (trigger point injection under C-arm)
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.

Experimental: Platelet rich plasma (PRP) with exosomes
PRP with exosomes at the center of the nucleus pulposus (2ml)
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.




Primary Outcome Measures :
  1. Visual analog scale (VAS) [ Time Frame: Change from Baseline VAS at 1 months ]
    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.

  2. Visual analog scale (VAS) [ Time Frame: Change from Baseline VAS at 3 months ]
    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.

  3. Visual analog scale (VAS) [ Time Frame: Change from Baseline VAS at 6 months ]
    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.

  4. Visual analog scale (VAS) [ Time Frame: Change from Baseline VAS at 12 months ]
    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.

  5. Roland Morris Disability Questionnaire (RDQ) [ Time Frame: Change from Baseline RDQ at 1 months ]
    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)

  6. Roland Morris Disability Questionnaire (RDQ) [ Time Frame: Change from Baseline RDQ at 3 months ]
    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 in RDQ will be assessed.

  7. Roland Morris Disability Questionnaire (RDQ) [ Time Frame: Change from Baseline RDQ at 6 months ]
    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 in RDQ will be assessed.

  8. Roland Morris Disability Questionnaire (RDQ) [ Time Frame: Change from Baseline RDQ at 12 months ]
    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 in RDQ will be assessed.

  9. SF 36 health questionnaire [ Time Frame: Change from Baseline SF 36 at 1 months ]

    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[2]:

    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.

  10. SF 36 health questionnaire [ Time Frame: Change from Baseline SF 36 at 3 months ]

    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[2]:

    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.

  11. SF 36 health questionnaire [ Time Frame: Change from Baseline SF 36 at 6 months ]

    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[2]:

    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.

  12. SF 36 health questionnaire [ Time Frame: Change from Baseline SF 36 at 12 months ]

    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[2]:

    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.

  13. Functional rating index [ Time Frame: Change from Baseline Functional rating index at 1 months ]
    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.

  14. Functional rating index [ Time Frame: Change from Baseline Functional rating index at 3 months ]
    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.

  15. Functional rating index [ Time Frame: Change from Baseline Functional rating index at 6 months ]
    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.

  16. Functional rating index [ Time Frame: Change from Baseline Functional rating index at 12 months ]
    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.


Secondary Outcome Measures :
  1. MRI [ Time Frame: Changes from baseline MRI findings will be assesed at 12 months ]

    magnetic resonance imaging to quantify grading of disc degeneration. *Grades 1, 2, and 3 are based on the signal intensity of the nucleus and inner fibers of anulus. For Grade 4, the margins between the inner and other fibers of the anulus at the posterior margin of the disc are indistinct.

    For Grade 5, the disc is uniformly hypointense, although there is no loss of disc space height. For Grades, 6, 7, and 8, there is progressive loss of disc space height. These could be broadly classified as mild, moderate, to severe loss of disc space height.

    Pfirrmann scoring Modic Grade




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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04849429


Contacts
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Contact: HIMANSHU BANSAL, ms 9634501234 hbansal@drhbf.org
Contact: Alnkrita agarwal, mbbs 9634100888 hbansal@drhbf.org

Locations
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India
Anupam Hospital Recruiting
Rudrapur, Uttarakhand, India, 263153
Contact: Himanshu Bansal, MS    9634501234    hbansal@drhbf.org   
Contact: Anupama Bansal, MD    9634501234    drbansalh2019@gmail.com   
Principal Investigator: Himanshu Bansal, MS         
Sub-Investigator: Anupama Bansal, MD         
Mother Cell Spinal Injury and Stem Cell Research, Anupam Hospital Recruiting
Rudrapur, Uttarakhand, India, 263153
Contact: Himanshu Bansal, MS    9634501234    hbansal@drhbf.org   
Contact: Anupama Bansal, MD    9634501234    drbansalh2019@gmail.com   
Principal Investigator: Himanshu Bansal, MS         
Sub-Investigator: Anupama Bansal, MD         
Sponsors and Collaborators
Dr. Himanshu Bansal Foundation
Investigators
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Principal Investigator: HIMANSHU BANSAL, MS HIMANSHU BANSAL FOUNDATION
Principal Investigator: JEREMY PONT, Mchiro PHOENIX HELSE Norway
Principal Investigator: DAVID WILSON, MBBS PHOENIX HELSE Norway
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Responsible Party: anupama agrawal, Principal Investigator, Dr. Himanshu Bansal Foundation
ClinicalTrials.gov Identifier: NCT04849429    
Other Study ID Numbers: HB/CLINICALTRIAL/01/2021
First Posted: April 19, 2021    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: ANYTHING ASKED WILL BE SHARED ANYTIME
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: ANYTIME
Access Criteria: ANYONE INTERESTED TO CRITICALLY EVALUATE OR REPRODUCE
URL: http://DRHBF.ORG

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by anupama agrawal, Dr. Himanshu Bansal Foundation:
intra-discal PRPEx Chronic Low Back Pain
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases