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

Primary Purpose

Osteoarthritis

Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Autologous cell therapy
Sponsored by
Dr. Grant M. Pagdin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Platelet Rich Plasma (PRP), Micronized Lipoaspirate (MAT), Bone Marrow Aspirate (BMA)

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 Should a participant become pregnant during the study, she will be withdrawn from further treatment and imaging, but can participate in symptom follow-up.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.

Sites / Locations

  • Pagdin HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group A - PRP plus Lipoaspirate

Group B - PRP plus Bone Marrow Aspirate

Group C - PRP plus Lipoaspirate plus Bone Marrow Aspirate

Arm Description

Equal proportions of PRP plus micronized adipose tissue (lipoaspirate). Total Volume varies by joint.

Equal proportions of PRP plus bone marrow aspirate. Total Volume varies by joint.

Equal proportions of PRP plus micronized adipose tissue (lipoaspirate) plus bone marrow aspirate. Total Volume varies by joint.

Outcomes

Primary Outcome Measures

Changes from baseline through to end of study for the Visual Analogue Scale (VAS).
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.
Changes from baseline through to the end of study for the Short Form 12 item version 2 (SF12-v2)
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

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.
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.
Comparison to evaluate the degree of change among treatment arms (Group A, Group B and Group C) baseline visit through to end of study.
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.
Flow cytometry
Numbers and viability of stem cells

Full Information

First Posted
May 28, 2019
Last Updated
September 26, 2022
Sponsor
Dr. Grant M. Pagdin
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1. Study Identification

Unique Protocol Identification Number
NCT03984461
Brief Title
The Combined Use of PRP With Lipoaspirate and/or Bone Marrow Aspirate in Osteoarthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Grant M. Pagdin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 240 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 80 in each group. The combination of biologic materials will be injected in to an arthritic joint.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, Platelet Rich Plasma (PRP), Micronized Lipoaspirate (MAT), Bone Marrow Aspirate (BMA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A - PRP plus Lipoaspirate
Arm Type
Active Comparator
Arm Description
Equal proportions of PRP plus micronized adipose tissue (lipoaspirate). Total Volume varies by joint.
Arm Title
Group B - PRP plus Bone Marrow Aspirate
Arm Type
Active Comparator
Arm Description
Equal proportions of PRP plus bone marrow aspirate. Total Volume varies by joint.
Arm Title
Group C - PRP plus Lipoaspirate plus Bone Marrow Aspirate
Arm Type
Active Comparator
Arm Description
Equal proportions of PRP plus micronized adipose tissue (lipoaspirate) plus bone marrow aspirate. Total Volume varies by joint.
Intervention Type
Biological
Intervention Name(s)
Autologous cell therapy
Intervention Description
Biologic material is harvested from the participant and re-injected into an osteoarthritic joint
Primary Outcome Measure Information:
Title
Changes from baseline through to end of study for the Visual Analogue Scale (VAS).
Description
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.
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).
Title
Changes from baseline through to the end of study for the Short Form 12 item version 2 (SF12-v2)
Description
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.
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).
Secondary Outcome Measure Information:
Title
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.
Description
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.
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).
Title
Comparison to evaluate the degree of change among treatment arms (Group A, Group B and Group C) baseline visit through to end of study.
Description
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.
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).
Title
Flow cytometry
Description
Numbers and viability of stem cells
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Capable of providing written informed consent and willing and able to adhere to all protocol requirements. Male or female at least 19 years of age at the time of providing written informed consent. 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: BMI > 35 Arthroscopic surgery to the treatment joint within 12 months Cortisone or HA injection within the last 3 months prior to stem cell injection Inability to hold antiplatelet therapy according to treating provider prior to procedure Kellgren & Lawrence Grade 4 Osteoarthritis Participants with a platelet count less than 100 x 109 Participants with a Hemoglobin less than 100 g/L Participants who have an active Infection with fever and/or elevated white blood cell (WBC) count Participants with an active Cancer diagnosis. Participants with autoimmune disorders including rheumatoid arthritis and lupus. 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. Participants with allergies to lidocaine, heparin, or epinephrine.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grant Pagdin, MD
Phone
250-717-3200
Email
info@pagdinhealth.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsey Hovey
Phone
250-717-3200
Email
lindsey@pagdinhealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Rosenfeld, MD
Organizational Affiliation
Quorum Review IRB
Official's Role
Study Chair
Facility Information:
Facility Name
Pagdin Health
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 6T8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. G Pagdin, MD
Phone
2507173200
Ext
2507173200
Email
info@pagdinhealth.com
First Name & Middle Initial & Last Name & Degree
Lindsey Hovey
Phone
2507173200
Ext
2507173200
Email
lindsey@pagdinhealth.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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