A Phase II, Randomized, Parallel-Group Study to Investigate the Combined Use of PRP with Lipoaspirate And/or Bone Marrow Aspirate in Osteoarthritis
Who is this study for? Adult patients with Osteoarthritis
What treatments are being studied? Platelet-Rich Plasma
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 79
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
Canada
Pagdin Health
RECRUITING
Kelowna
Contact Information
Primary
Grant Pagdin, MD
info@pagdinhealth.com
250-717-3200
Backup
Michelle Murtha, MScN
michelle@pagdinhealth.com
250-717-3200
Time Frame
Start Date: 2020-09-01
Estimated Completion Date: 2027-12
Participants
Target number of participants: 240
Treatments
Active_comparator: Group A - PRP plus Lipoaspirate
Equal proportions of PRP plus micronized adipose tissue (lipoaspirate). Total Volume varies by joint.
Active_comparator: Group B - PRP plus Bone Marrow Aspirate
Equal proportions of PRP plus bone marrow aspirate. Total Volume varies by 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.
Related Therapeutic Areas
Sponsors
Leads: Dr. Grant M. Pagdin