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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03984461
• Other study ID #: OASC2015
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2020
• Est. completion date: December 2025

Study information

• Verified date: September 2022
• Source: Pagdin Health
• Contact: Grant Pagdin, MD
• Phone: 250-717-3200
• Email: info[@]pagdinhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Biological:
• Autologous cell therapy
Biologic material is harvested from the participant and re-injected into an osteoarthritic joint

Locations

Country	Name	City	State
Canada	Pagdin Health	Kelowna	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Grant M. Pagdin

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	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.	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).
Secondary	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.	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	Flow cytometry	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.