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The Combined Use of PRP With Lipoaspirate and/or Bone Marrow Aspirate in Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03984461
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Grant M. Pagdin, Pagdin Health

Brief Summary:
To demonstrate the efficacy of the combined use of platelet-rich plasma (PRP) with lipoaspirate and/or bone marrow aspirate in osteoarthritis of major joints, and to compare the outcomes achieved using three combinations: PRP plus lipoaspirate, PRP plus bone marrow aspirate, and PRP plus both lipoaspirate and bone marrow aspirate.

Condition or disease Intervention/treatment Phase
Osteoarthritis Biological: Autologous cell therapy Phase 2

Detailed Description:

The purpose of this study is to demonstrate the efficacy of the combined use of platelet-rich plasma (PRP) with lipoaspirate and/or bone marrow aspirate in osteoarthritis of major joints, and to compare the outcomes achieved using three combinations: PRP plus lipoaspirate, PRP plus bone marrow aspirate, and PRP plus both lipoaspirate and bone marrow aspirate.

A total of 255 participants will be randomly assigned to one of three treatment groups: Group A will receive PRP plus lipoaspirate, Group B will receive PRP plus bone marrow aspirate, and Group C will receive tri-partite therapy of PRP + lipoaspirate + bone marrow aspirate which allows for 85 in each group. The combination of biologic materials will be injected in to an arthritic joint.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group A - PRP plus Lipoaspirate Group B - PRP plus Bone Marrow Aspirate Group C - PRP plus Lipoaspirate plus Bone Marrow Aspirate
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Parallel-Group Study to Investigate the Combined Use of PRP With Lipoaspirate and/or Bone Marrow Aspirate In Osteoarthritis
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: Group A - PRP plus Lipoaspirate
Equal proportions of PRP plus micronized adipose tissue (lipoaspirate). Total Volume varies by joint.
Biological: Autologous cell therapy
Biologic material is harvested from the participant and re-injected into an osteoarthritic joint

Active Comparator: Group B - PRP plus Bone Marrow Aspirate
Equal proportions of PRP plus bone marrow aspirate. Total Volume varies by joint.
Biological: Autologous cell therapy
Biologic material is harvested from the participant and re-injected into an osteoarthritic joint

Active Comparator: Group C - PRP plus Lipoaspirate plus Bone Marrow Aspirate
Equal proportions of PRP plus micronized adipose tissue (lipoaspirate) plus bone marrow aspirate. Total Volume varies by joint.
Biological: Autologous cell therapy
Biologic material is harvested from the participant and re-injected into an osteoarthritic joint




Primary Outcome Measures :
  1. Changes from baseline through to end of study for the Visual Analogue Scale (VAS). [ Time Frame: The VAS will be measured at baseline (week 1) through to the end of the study (week 104). To test for improvement, comparisons to baseline will be made at 6 months (week 26,) 12 months (week 52) and 24 months (week 104). ]
    Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity. This scale measures ranges from 0 whereby the patient has no discomfort or distress to 10 where the patient has agonizing pain and is in unbearable distress. (0 - None, 1, 2 - Annoying, 3, 4 - Uncomfortable, 5, 6 - Dreadful, 7, 8 - Horrible, 9, 10 - Agonizing). The patient can place an x anywhere on the continuum between 0-10 based on their level of discomfort . We will then measure the scale using a ruler to the tenth of a point. The VAS scale will be completed at each visits 2-7. Comparisons will be made from baseline to end of study to determine the overall improvement.

  2. Changes from baseline through to the end of study for the Short Form 12 item version 2 (SF12-v2) [ Time Frame: The SF12-v2 will be measured at baseline (week 1) through to the end of the study (week 104). To test for improvement, comparisons to baseline will be made at 6 months (week 26,) 12 months (week 52) and 24 months (week 104). ]
    The SF-12 is a validated and widely used twelve question health survey used to assess health related quality of life from the patients perspective. The SF12-v2 items are scored so that a higher score means a better health. For example, the functioning items are scored so that a higher score represents better functioning, whereby pain items scored so that a high score indicates freedom from pain. The SF12-v2 will be completed at each visits 2-7. Comparisons will be made from baseline to end of study to determine the overall improvement.


Secondary Outcome Measures :
  1. Comparison to evaluate the degree of change among treatment arms (Group A, Group B and Group C) from baseline visit through to end of study. [ Time Frame: The VAS will be measured at baseline (week 1) through to the end of the study (week 104). To test for improvement, comparisons to baseline will be made at 6 months (week 26,) 12 months (week 52) and 24 months (week 104). ]
    To evaluate the variations among the three treatment arms (lipoapirate [group A], bone marrow aspirate [group B], and lipoasiprate and bone marrow aspirate [group c] we will use the overall average of the VAS for each group. It is the investigator's hypothesis that we anticipate that group c might have a superior outcome to either group A or group B.

  2. Comparison to evaluate the degree of change among treatment arms (Group A, Group B and Group C) baseline visit through to end of study. [ Time Frame: The VAS will be measured at baThe SF12-v2 will be measured at baseline (week 1) through to the end of the study (week 104). To test for improvement, comparisons to baseline will be made at 6 months (week 26,) 12 months (week 52) and 24 months (week 104). ]
    To evaluate the variations among the three treatment arms (lipoapirate [group A], bone marrow aspirate [group B], and lipoasiprate and bone marrow aspirate [group c] we will use the overall average of the SF12-v2 for each group. It is our hypothesis that we anticipate that group c might have a superior outcome to either group A or group B.

  3. Flow cytometry [ Time Frame: Visit 2 (Week 1) Samples are collected at visit 2 (week 1) and sent away for analysis by a university. The results will be received from the university prior to end for overall data analysis. ]
    Numbers and viability of stem cells



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Capable of providing written informed consent and willing and able to adhere to all protocol requirements.
  2. Male or female at least 19 years of age at the time of providing written informed consent.
  3. Evidence of OsteoArthritis in a major joint requires recent (within one year) imaging, either by x-ray or MRI. Kellgren & Lawrence Grades 1-3 are accepted for participation.

Exclusion Criteria:

  1. BMI > 35
  2. Arthroscopic surgery to the treatment joint within 12 months
  3. Cortisone or HA injection within the last 3 months prior to stem cell injection
  4. Inability to hold antiplatelet therapy according to treating provider prior to procedure
  5. Kellgren & Lawrence Grade 4 Osteoarthritis
  6. Participants with a platelet count less than 100 x 109
  7. Participants with a Hemoglobin less than 100 g/L
  8. Participants who have an active Infection with fever and/or elevated white blood cell (WBC) count
  9. Participants with an active Cancer diagnosis.
  10. Participants with autoimmune disorders including rheumatoid arthritis and lupus.
  11. Women who are pregnant will be excluded due to the possibility of fetal harm associated with x-rays. Should a participant become pregnant during the study, she will be withdrawn from further treatment and imaging, but can participate in symptom follow-up. Female participants of childbearing potential will be counseled at screening about contraception and encouraged to use birth control for the duration of the study.
  12. Participants with allergies to lidocaine, heparin, or epinephrine.

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): NCT03984461


Contacts
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Contact: Grant Pagdin, MD 250-717-3200 grant@pagdinhealth.com
Contact: Jordin Kupidy 250-717-3200 jordin@pagdinhealth.ca

Sponsors and Collaborators
Dr. Grant M. Pagdin
Investigators
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Study Chair: Stephen Rosenfeld, MD Quorum Review IRB

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Responsible Party: Dr. Grant M. Pagdin, Qualified Investigator, Pagdin Health
ClinicalTrials.gov Identifier: NCT03984461     History of Changes
Other Study ID Numbers: OASC2015
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Dr. Grant M. Pagdin, Pagdin Health:
Osteoarthritis
Platelet Rich Plasma (PRP)
Micronized Lipoaspirate (MAT)
Bone Marrow Aspirate (BMA)

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases