The Combined Use of PRP with Lipoaspirate And/or Bone Marrow Aspirate in Osteoarthritis

NCT03984461 | Recruiting Phase 2

• 1 other identifier: OASC2015
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Osteoarthritis; Platelet Rich Plasma (PRP); Micronized Lipoaspirate (MAT); Bone Marrow Aspirate (BMA)

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  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 Outcomes (3)

• 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.

  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.

  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

  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.

Study Arms (3)

Group A - PRP plus Lipoaspirate

ACTIVE COMPARATOR

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

Biological: Autologous cell therapy

Group B - PRP plus Bone Marrow Aspirate

ACTIVE COMPARATOR

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

Biological: Autologous cell therapy

Group C - PRP plus Lipoaspirate plus Bone Marrow Aspirate

ACTIVE COMPARATOR

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

Biological: Autologous cell therapy

Interventions

Autologous cell therapy BIOLOGICAL

Biologic material is harvested from the participant and re-injected into an osteoarthritic joint

Group A - PRP plus Lipoaspirate; Group B - PRP plus Bone Marrow Aspirate; Group C - PRP plus Lipoaspirate plus Bone Marrow Aspirate

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Grant M. Pagdin: lead

Study Sites (1)

Pagdin Health

Kelowna, British Columbia, V1Y 6T8, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Stephen Rosenfeld, MD

  Quorum Review IRB

  STUDY CHAIR

Central Study Contacts

Grant Pagdin, MD

CONTACT

250-717-3200; info@pagdinhealth.com

Michelle Murtha, MScN

CONTACT

250-717-3200; michelle@pagdinhealth.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Qualified Investigator

Model Details: Group A - PRP plus Lipoaspirate Group B - PRP plus Bone Marrow Aspirate Group C - PRP plus Lipoaspirate plus Bone Marrow Aspirate

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 13, 2019
• Study Start: September 1, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)