Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis

Study Overview
=================
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.

Official Title
-----------------
Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis

Conditions
-----------------
Osteo Arthritis Knee

Intervention / Treatment
-----------------
* Biological: Bone Marrow Aspirate Concentrate
* Device: Angel Concentrated Platelet Rich Plasma (cPRP) System


Participation Criteria
=================
Eligibility Criteria
-----------------
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: -

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bone marrow aspiration concentrate using the Angel System<br>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<br>* 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.<br>* Other names: BMAC;Device: Angel Concentrated Platelet Rich Plasma (cPRP) System<br>* 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.<br>* Other names: The Angel System;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
moderate to severe knee osteoarthritis, total knee replacement, bone marrow, stem cell-based therapy, arthroscopy