Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT04716803
Status
Recruiting
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Conditions

  • Osteo Arthritis Knee

Eligibility Criteria

Sex
ALL
Age
45 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Bone Marrow Aspirate Concentrate — BIOLOGICAL
    Aspiration of bone marrow will be collected from the patient's pelvic bone region and subsequently concentrated with the Angel Concentrated Platelet Rich Plasma (cPRP) System.
  • Angel Concentrated Platelet Rich Plasma (cPRP) System — DEVICE
    Aspiration of bone marrow will be collected from the patient's pelvic bone region and subsequently concentrated with the Angel Concentrated Platelet Rich Plasma (cPRP) System.

Study Details

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.

Key Dates

Start date
Jul 8, 2020
Status verified
Jan 2022
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Patients with at least one severe adverse event [ Time Frame: End of Study (12 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San Diego Koman Outpatient PavilionLa JollaCalifornia92037
Karen Cuervo, BS
[email protected]
858-249-3038
Kenneth Kalunian, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of California San Diego Koman Outpatient Pavilion· La Jolla, CA

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