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Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis (BMAC)

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ClinicalTrials.gov Identifier: NCT04716803
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : January 26, 2022
Sponsor:
Information provided by (Responsible Party):
Kenneth Kalunian, University of California, San Diego

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Biological: Bone Marrow Aspirate Concentrate Device: Angel Concentrated Platelet Rich Plasma (cPRP) System Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis
Actual Study Start Date : July 8, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
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.

 Biological: Bone Marrow Aspirate Concentrate
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 Name: BMAC

Device: Angel Concentrated Platelet Rich Plasma (cPRP) System
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 Name: The Angel System


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Rheumatic disease characterization [ Time Frame: End of study (12 months) ]
    Biological samples (blood, urine, synovial tissue) are characterized via molecular and histological analysis.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04716803


Contacts
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Contact: Kenneth Kalunian, MD 858-246-2381 kkalunian@health.ucsd.edu

Locations
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United States, California
University of California San Diego Koman Outpatient Pavilion Recruiting
La Jolla, California, United States, 92037
Contact: Karen Cuervo, BS    858-249-3038    kcuervo@health.ucsd.edu   
Principal Investigator: Kenneth Kalunian, MD         
Sponsors and Collaborators
University of California, San Diego
More Information
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Responsible Party: Kenneth Kalunian, Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04716803    
Other Study ID Numbers: 180916
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: January 26, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Kenneth Kalunian, University of California, San Diego:
moderate to severe knee osteoarthritis
total knee replacement
bone marrow
stem cell-based therapy
arthroscopy
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases