Clinical trial NCT04716803: Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis
Official title: Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: moderate to severe knee osteoarthritis
total knee replacement
bone marrow
stem cell-based therapy
arthroscopy
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 10
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

-

Primary outcomes:
measure: Patients with at least one severe adverse event
timeFrame: End of Study (12 months)
Secondary outcomes:
measure: Structural change in knee from baseline measured by the VAS (Visual Analog Scale) in the American College of Rheumatology/Knee Osteoarthritis Assessment Scale (ACR/KOAS).
timeFrame: End of study (12 months)
measure: Self reported health from baseline through end of study measured by the 36-Item Short Form Survey Instrument (SF-36) Health Survey and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
timeFrame: End of study (12 months)
Other outcomes:
measure: Rheumatic disease characterization
timeFrame: End of study (12 months)
Locations:
city: La Jolla
country: United States
facility: University of California San Diego Koman Outpatient Pavilion
state: California
Study officials:
References: