RecruitingNot ApplicableNCT04716803

Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis


Sponsor

University of California, San Diego

Enrollment

10 participants

Start Date

Jul 8, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to investigate the safety and effectiveness of bone marrow aspirate concentrate (BMAC) in patients with moderate to severe osteoarthritis of the knee. BMAC provides a rich source of mesenchymal stem cells (MSCs) and is a stem cell-based therapy that has been reported to preserve or improve the structure of joints. The Angel System is the device used in this study to concentrate bone marrow from the patient and is intended to separate a mixture of blood and bone marrow and collect plasma rich platelets preoperative to a surgical procedure. The goal of this study is to identify whether BMAC can be an effective and safe treatment for patients with osteoarthritis of the knee.


Eligibility

Min Age: 45 YearsMax Age: 75 Years

Inclusion Criteria4

  • Kellgren Lawrence radiographic grade IV
  • Need for a total knee arthroscopy by the patients primary care provider/or orthopedist.
  • Persistent pain in target knee that is unresponsive to standard of care including acetametaphine, non-steroidal anti-inflammatory drugs, physical therapy and/or intraarticular corticosteroids and/or hyaluronic acid preparations.
  • Males or females aged 45-75.

Exclusion Criteria1

  • \-

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Interventions

BIOLOGICALBone Marrow Aspirate Concentrate

Aspiration of bone marrow will be collected from the patient's pelvic bone region and subsequently concentrated with the Angel Concentrated Platelet Rich Plasma (cPRP) System.

DEVICEAngel Concentrated Platelet Rich Plasma (cPRP) System

Aspiration of bone marrow will be collected from the patient's pelvic bone region and subsequently concentrated with the Angel Concentrated Platelet Rich Plasma (cPRP) System.


Locations(1)

University of California San Diego Koman Outpatient Pavilion

La Jolla, California, United States

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NCT04716803


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