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Conventional Platelet-Rich Plasma Versus Concentrated Bone Marrow Stem Cell Injections for Osteoarthritis of the Knee

A Randomized, Single-Blinded, Controlled Trial Comparing Conventional Platelet Rich Plasma (PRP) to Concentrated Bone Marrow Aspirate (BMAC) for Osteoarthritis of the Knee


Phase 2

DESCRIPTION:

The Mayo Clinic in Florida is conducting a trial comparing two treatments for osteoarthritis of the knee: injections of bone marrow aspirate concentrate (BMAC) stem cells taken from the patient’s hip bone, and injections of platelet-rich plasma drawn by IV. Both treatments are delivered directly into the knee. Follow up will be needed at 1 week, 6 weeks, 6 months, and 12 months after the injections, plus X-rays before the treatment and at 12 months.


PATIENT MUST:

  • Be 18 years of age and older
  • Have a diagnosis of osteoarthritis in both legs and pain in one knee meeting certain grades
  • Subjects must have previously tried 6 weeks of one of the following conservative treatments: Activity modification, weight loss, physical therapy, anti-inflammatory, or injection therapy
  • Not be pregnant or breastfeeding

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. Recovery of the plasma or bone marrow aspirate. Each require a short hospital visit, though the bone marrow aspirate is a more complex procedure.
  3. Follow up will be needed at 1 week, 6 weeks, 6 months, and 12 months after the injections, plus X-rays before the treatment and at 12 months.

LOCATIONS AND CONTACTS:

The study site is at the Mayo Clinic in Jacksonville, FL. Map.

Contacts:

Shane Shapiro, MD  |  (904) 953-2496  |  [email protected]

 

 

SPONSOR INFORMATION:

Mayo Clinic

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03271229

 

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