Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis

Status: Recruiting
Location: See location...
Intervention Type: Biological, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
University of California San Diego Koman Outpatient Pavilion
RECRUITING
La Jolla
Contact Information
Primary
Kenneth Kalunian, MD
kkalunian@health.ucsd.edu
858-246-2381
Time Frame
Start Date: 2020-07-08
Estimated Completion Date: 2023-12-31
Participants
Target number of participants: 10
Treatments
Experimental: Bone marrow aspiration concentrate using the Angel System
Bone marrow aspirate concentrate (BMAC) will be administered via injection to the knee of interest on day 14 of the study.~Bone marrow aspiration will be concentrated using the Angel System.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov