Bone Marrow Aspirate Concentrate (BMAC) for Knee Osteoarthritis

This study is looking at whether Bone Marrow Aspirate Concentrate (BMAC) is a safe and effective treatment for people with moderate to severe knee osteoarthritis. BMAC uses your own bone marrow, which contains special cells called mesenchymal stem cells (MSCs) that may help repair joints. In this study, bone marrow will be taken from your hip bone and concentrated using a device called the Angel Concentrated Platelet Rich Plasma (cPRP) System. This concentrated bone marrow will then be put into your knee. The study is enrolling about 10 people between 45 and 75 years old who have severe knee osteoarthritis (Kellgren Lawrence radiographic grade IV) and are scheduled for total knee replacement. To be eligible, your knee pain must not have improved with standard treatments like pain relievers, physical therapy, or injections. The main goal is to see if there are any severe side effects after 12 months. The current recruitment status is unclear.

Study design
This is a pilot, open-label study, meaning both you and the study team will know what treatment you are receiving. It is not randomized and will take place at a single location, involving about 10 participants.
What's involved
You will have bone marrow taken from your pelvic bone and then immediately put back into your knee several weeks before your total knee replacement. Blood and tissue samples will be collected at scheduled visits, and you will have physical exams and fill out questionnaires.
Compensation
Not stated in the trial record.
Follow-up
You will be monitored for adverse events throughout the trial, with severe adverse events measured at the end of the study (12 months).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04716803

Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis

Recruiting
NAAges 45–75InterventionalTreatment
University of California, San Diego
~10 participants
Updated 2022-01-26 on ClinicalTrials.gov
What's tested:Bone Marrow Aspirate ConcentrateAngel Concentrated Platelet Rich Plasma (cPRP) System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patients with at least one severe adverse event
Measured over End of Study (12 months)
Osteo Arthritis Knee
1 sites across 1 states
California1

Opens a ready-to-send draft in your own email app — review before sending.

  • Patients with at least one severe adverse eventEnd of Study (12 months)

    The number of life-threatening severe adverse events as determined by the standard FDA guidelines for adverse events that are deemed to be related to autologous BMAC concentrated by the Angel System and delivered via intra-articular injection into the knee.