Taking people in United StatesNo phase

Bone marrow cell treatment for knee osteoarthritis

Tests bone marrow aspirate concentrate in people with moderate to severe knee osteoarthritis.

Key facts

Who runs it: University of California, San Diego
Where: La Jolla, United StatesSee the site
Trial code: NCT04716803
Registry title: Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis
Status: Recruiting
People taking part: 10 people, planned
Started: 8 Jul 2020
Planned end: 31 Dec 2023
Type of study: Interventional
Treatments tested: Bone Marrow Aspirate Concentrate
Angel Concentrated Platelet Rich Plasma (cPRP) System
Record updated: 26 January 2022

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with severe knee osteoarthritis (wear-and-tear arthritis) who have been told they need knee surgery. It tests an injection made from their own concentrated bone marrow.

Age: 45 to 75 years
Sex: Men and women
Disease stage: Knee osteoarthritis at Kellgren Lawrence X-ray grade IV. The primary care provider or orthopedist says a total knee arthroscopy is needed.
Earlier treatment: Lasting pain in the knee that did not get better with standard care. This includes acetametaphine, non-steroidal anti-inflammatory drugs, physical therapy and/or intraarticular corticosteroids and/or hyaluronic acid preparations.

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

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

Who cannot take part

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 45 and 75 years old?

Where in United States

University of California San Diego Koman Outpatient PavilionLa Jolla, United StatesContact: Karen Cuervo, BSTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

Bone marrow aspiration concentrate using the Angel SystemTreatment being tested
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.
Treatment: Bone Marrow Aspirate Concentrate and Angel Concentrated Platelet Rich Plasma (cPRP) System