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NCT Number: NCT04716803

Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis

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.

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Key information

Conditions

Osteo Arthritis Knee

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Diego Koman Outpatient Pavilion

La Jolla, California, 92037, United States

Location status: Recruiting

Location contact

Karen Cuervo, BS

CONTACT

[email protected]

858-249-3038

Kenneth Kalunian, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

-

Treatment and study plan

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.

Other names: BMAC

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.

Other names: The Angel System

Primary outcomes

  1. Patients with at least one severe adverse event

    Time frame: End 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.

Secondary outcomes

  1. 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).

    Time frame: End of study (12 months)

    The VAS ranges from 0 to 100 with 0 indicating no damage and higher scores indicating more severe damage.

  2. 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).

    Time frame: End of study (12 months)

    SF-36 scores are measured via ranges from 0 to 100.

Other outcomes

  1. Rheumatic disease characterization

    Time frame: End of study (12 months)

    Biological samples (blood, urine, synovial tissue) are characterized via molecular and histological analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Kenneth Kalunian, MD

CONTACT

[email protected]

858-246-2381

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Acronym: BMAC

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 20, 2021
Registry last updated
Jan 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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