Clinical trial NCT03984461: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Platelet Rich Plasma (PRP)
Micronized Lipoaspirate (MAT)
Bone Marrow Aspirate (BMA)
Lead sponsor: Pagdin Health
Sponsor class: OTHER
First posted: 2019-06-13
Enrollment: 240
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A - PRP plus Lipoaspirate Group B - PRP plus Bone Marrow Aspirate Group C - PRP plus Lipoaspirate plus Bone Marrow Aspirate
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Changes from baseline through to end of study for the Visual Analogue Scale (VAS).
timeFrame: 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).
measure: Changes from baseline through to the end of study for the Short Form 12 item version 2 (SF12-v2)
timeFrame: 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:
measure: 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.
timeFrame: 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).
measure: Comparison to evaluate the degree of change among treatment arms (Group A, Group B and Group C) baseline visit through to end of study.
timeFrame: 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).
measure: Flow cytometry
timeFrame: 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.
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: Pagdin Health
state: British Columbia
Study officials:
affiliation: Quorum Review IRB
name: Stephen Rosenfeld, MD
role: STUDY_CHAIR
References: