RECRUITING

Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis

Quick Facts

Study Start:2020-07-08
Study Completion:2023-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04716803

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Kellgren Lawrence radiographic grade IV
  2. 2. Need for a total knee arthroscopy by the patients primary care provider/or orthopedist.
  3. 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. 4. Males or females aged 45-75.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Kenneth Kalunian, MD
CONTACT
858-246-2381
kkalunian@health.ucsd.edu

Study Locations (Sites)

University of California San Diego Koman Outpatient Pavilion
La Jolla, California, 92037
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-08
Study Completion Date2023-12-31

Study Record Updates

Study Start Date2020-07-08
Study Completion Date2023-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Osteo Arthritis Knee