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

September 26, 2022 updated by: Dr. Grant M. Pagdin

A Phase II, Randomized, Parallel-Group Study to Investigate the Combined Use of PRP With Lipoaspirate and/or Bone Marrow Aspirate In Osteoarthritis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 6T8

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
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.
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).
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 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.
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).
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Grant M. Pagdin

Investigators

  • Study Chair: Stephen Rosenfeld, MD, Quorum Review IRB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2020

Primary Completion (ANTICIPATED)

December 1, 2025

Study Completion (ANTICIPATED)

December 1, 2025

Study Registration Dates

First Submitted

May 28, 2019

First Submitted That Met QC Criteria

June 12, 2019

First Posted (ACTUAL)

June 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OASC2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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