The Combined Use of PRP with Lipoaspirate And/or Bone Marrow Aspirate in Osteoarthritis
Recruiting · NCT03984461 · Interventional (participants receive a specific treatment) · Lead sponsor: Dr. Grant M. Pagdin
View the official record on ClinicalTrials.gov →Interventions studied
Autologous cell therapy
What this trial is about
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.
Who can take part
Age range
19 Years to 79 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 Should a participant become pregnant during the study, she will be withdrawn from further treatment and imaging, but can participate in symptom follow-up.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.
Where it is running
1 location listed.
- Pagdin Health - Kelowna, British Columbia, Canada