Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis

Osteo Arthritis Knee Clinical Trial

— BMAC  

Official title:

Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04716803
• Other study ID #: 180916
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2022
• Source: University of California, San Diego
• Contact: Kenneth Kalunian, MD
• Phone: 858-246-2381
• Email: kkalunian[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of California San Diego Koman Outpatient Pavilion	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rheumatic disease characterization	Biological samples (blood, urine, synovial tissue) are characterized via molecular and histological analysis.	End of study (12 months)
Primary	Patients with at least one severe adverse event	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.	End of Study (12 months)
Secondary	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).	The VAS ranges from 0 to 100 with 0 indicating no damage and higher scores indicating more severe damage.	End of study (12 months)
Secondary	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).	SF-36 scores are measured via ranges from 0 to 100.	End of study (12 months)