Actively Recruiting
Bone Marrow Aspirate Concentrate (BMAC) Treatment for Knee Osteoarthritis
Led by University of California, San Diego · Updated on 2022-01-26
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study the safety and potential effectiveness of bone marrow aspirate concentrate (BMAC) for patients with moderate to severe osteoarthritis of the knee. BMAC is a stem cell-based therapy that provides a rich source of mesenchymal stem cells (MSCs) and may help preserve or improve joint structure. The study uses the Angel System device to concentrate bone marrow and collect plasma-rich platelets before surgery. Patients who need total knee replacement will have bone marrow taken from their pelvic region several weeks before surgery. This marrow is concentrated using the Arthrex Angel Concentrated Platelet Rich Plasma (cPRP) System and then injected arthroscopically into the affected knee. This is a pilot, open-label, non-randomized study conducted at a single institution. Blood and tissue samples will be collected for detailed analysis, and adverse events will be monitored. Participants will undergo physical exams and complete standardized health questionnaires to assess healing and health status. The primary outcome measures include monitoring for severe adverse events over 12 months. Secondary outcomes involve measuring structural knee changes using pain and function scales such as the Visual Analog Scale (VAS) and American College of Rheumatology/Knee Osteoarthritis Assessment Scale (ACR/KOAS), along with self-reported health surveys. The total study duration for each participant is 12 months.
CONDITIONS
Brief Title
Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Kellgren Lawrence radiographic grade IV osteoarthritis
- Need for total knee replacement surgery as determined by a healthcare provider
- Persistent knee pain unresponsive to standard treatments including acetaminophen, anti-inflammatory drugs, physical therapy, corticosteroids, or hyaluronic acid
- Adults aged 45 to 75 years, male or female
You will not qualify if you...
- None specified
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day treatment on Day 14
Participants undergo bone marrow aspiration from the pelvic region. The aspirate is concentrated using the Angel Concentrated Platelet Rich Plasma (cPRP) System and immediately administered arthroscopically to the knee of interest.
1 treatment visit (in-person)
Duration - Up to 12 months after treatment
Participants are monitored through physical exams, standardized questionnaires, and sample collections to assess healing and adverse events.
Multiple follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
University of California San Diego Koman Outpatient Pavilion
La Jolla, California, United States, 92037
Actively Recruiting
Research Team
K
Kenneth Kalunian, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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