The Combined Use of PRP with Lipoaspirate And/or Bone Marrow Aspirate in Osteoarthritis
NCT ID: NCT03984461
Last Updated: 2024-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
240 participants
INTERVENTIONAL
2020-09-01
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Bone Marrow Aspirate Compared to Platelet Rich Plasma for Treating Knee Osteoarthritis
NCT03289416
Conventional Platelet-Rich Plasma Versus Concentrated Bone Marrow Stem Cell Injections for Osteoarthritis of the Knee
NCT03271229
Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis
NCT01931007
Microfragmented Adipose Tissue Versus Platelet-rich Plasma for Knee Osteoarthritis: a Randomized Comparative Trial
NCT04351087
Autologous BMA vs Saline and LAM + LP-PRP vs Saline Evaluations in Knee OA
NCT05517434
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A - PRP plus Lipoaspirate
Equal proportions of PRP plus micronized adipose tissue (lipoaspirate). Total Volume varies by joint.
Autologous cell therapy
Biologic material is harvested from the participant and re-injected into an osteoarthritic joint
Group B - PRP plus Bone Marrow Aspirate
Equal proportions of PRP plus bone marrow aspirate. Total Volume varies by joint.
Autologous cell therapy
Biologic material is harvested from the participant and re-injected into an osteoarthritic joint
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.
Autologous cell therapy
Biologic material is harvested from the participant and re-injected into an osteoarthritic joint
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Autologous cell therapy
Biologic material is harvested from the participant and re-injected into an osteoarthritic joint
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
19 Years
79 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dr. Grant M. Pagdin
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Grant M. Pagdin
Qualified Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stephen Rosenfeld, MD
Role: STUDY_CHAIR
Quorum Review IRB
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pagdin Health
Kelowna, British Columbia, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OASC2015
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.