Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis

NCT04716803 | Recruiting DMC FDA Device

• 1 other identifier: 180916
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee

Keywords

moderate to severe knee osteoarthritis; total knee replacement; bone marrow; stem cell-based therapy; arthroscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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).

  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).

  End of study (12 months)

Other Outcomes (1)

• Rheumatic disease characterization

  End of study (12 months)

Study Arms (1)

Bone marrow aspiration concentrate using the Angel System

EXPERIMENTAL

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; Device: Angel Concentrated Platelet Rich Plasma (cPRP) System

Interventions

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.

Also known as: BMAC

Bone marrow aspiration concentrate using the Angel System

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.

Also known as: The Angel System

Bone marrow aspiration concentrate using the Angel System

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego Koman Outpatient Pavilion

La Jolla, California, 92037, United States

RECRUITING

MeSH Terms

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Kenneth Kalunian, MD

CONTACT

858-246-2381; kkalunian@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: January 20, 2021
• Study Start: July 8, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 26, 2022

Record last verified: 2022-01

Locations

US (1)