Summary

Eligibility
for people ages 45-75 (full criteria)
Location
at La Jolla, California
Dates
study started
estimated completion
Principal Investigator
by Kenneth Kalunian, MD

Description

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.

Details

This is a pilot open-label, non-randomized, single institution study of BMAC administration in patient's with moderate to severe osteoarthritis of the knee who will undergo total knee replacement. Several weeks prior to total knee replacement, patients will have a sample of bone marrow taken from their pelvic region and concentrated using an investigational device called the Arthrex Angel Concentrated Platelet Rich Plasma (cPRP) System also known as the Angel System. The concentrated bone marrow will be immediately delivered back to the patient arthroscopically to the knee of interest. Blood and tissues samples will be collected at scheduled visits for molecular and histological analysis. Adverse events will be monitored throughout the trial. Assessment of healing will be performed by physical exam and standardized questionnaires related to the health of the patient.

Keywords

Osteo Arthritis Knee moderate to severe knee osteoarthritis total knee replacement bone marrow stem cell-based therapy arthroscopy Osteoarthritis Osteoarthritis, Knee Bone Marrow Aspirate Concentrate Angel Concentrated Platelet Rich Plasma (cPRP) System Bone marrow aspiration concentrate using the Angel System

Eligibility

You can join if…

Open to people ages 45-75

  1. Kellgren Lawrence radiographic grade IV
  2. Need for a total knee arthroscopy by the patients primary care provider/or orthopedist.
  3. 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.
  4. Males or females aged 45-75.

You CAN'T join if...

Location

  • University of California San Diego Koman Outpatient Pavilion accepting new patients
    La Jolla California 92037 United States

Lead Scientist at UCSD

  • Kenneth Kalunian, MD
    Research Interests - Innovative strategies for the treatment of patients with rheumatoid arthritis and other rheumatic diseases - Prognostic and predictive factors for outcomes in rheumatic diseases

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT04716803
Study Type
Interventional
Last Updated