Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis

NCT ID: NCT04716803

Last Updated: 2022-01-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-08
• Study Completion Date: 2023-12-31

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.

Conditions

Osteo Arthritis Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Bone Marrow Aspirate Concentrate

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: DEVICE

Other Intervention Names

BMAC; The Angel System

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

-

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Kenneth Kalunian

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of California San Diego Koman Outpatient Pavilion

La Jolla, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kenneth Kalunian, MD

Role: CONTACT

kkalunian@health.ucsd.edu

858-246-2381

Facility Contacts

Karen Cuervo, BS

Role: primary

kcuervo@health.ucsd.edu

858-249-3038

Other Identifiers

180916

Identifier Type: -

Identifier Source: org_study_id