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Taking people in CanadaPhase 2

The Combined Use of PRP with Lipoaspirate And/or Bone Marrow Aspirate in Osteoarthritis

Key facts

Where
Kelowna, CanadaSee the site
Phase
Phase 2

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 19 and 79 years old?

Source: NCT03984461, who can take part

Where in Canada

  • Pagdin HealthKelowna, CanadaContact: Dr. G Pagdin, MDTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Dr. Grant M. Pagdin
Trial code
NCT03984461
Record updated
15 November 2024
Original description
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.Read full original descriptionShow less

A Phase II, Randomized, Parallel-Group Study to Investigate the Combined Use of PRP with Lipoaspirate And/or Bone Marrow Aspirate in Osteoarthritis

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.

Inclusion: 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: 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; Participants with an active Cancer diagnosis; Participants with autoimmune disorders including rheumatoid arthritis and lupus; Participants with allergies to lidocaine, heparin, or epinephrine; 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; BMI > 35; Kellgren \& Lawrence Grade 4 Osteoarthritis; 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.

ClinicalTrials.gov NCT03984461