The aging process introduces many new challenges. Those with primary osteoarthritis face a debilitating disease materially impacting the aging population. The population of 65 and over are growing in numbers. Today they represent about 45 million; this will double by 2060. Over 237 million are afflicted with osteoarthritis worldwide. In the United States up to 52.5 million face the condition. It is estimated that 80% of the U.S. population have radiographic evidence of osteoarthritis by age 65, although only 60% will have symptoms. Nonetheless, that represents a lot of our aging population that will battle with a debilitating disease; they will face extensive joint damage, excruciating pain leading to loss of activity and in some cases, depression. This can lead to a downward spiral representing a hellish final years.
Last year the Marcus Foundation announced they would grant $13 million to fund a multicenter clinical trial studying various stem cell options to treat osteoarthritis. The grantees included the Emery Orthopedics & Spine Center, Sanford Health, Duke University, Andrews Institute and the Georgia Institute of Technology.
Principal Investigator Scott D. Bowden MD, professor of orthopaedic surgery at Emory University School of Medicine and director of the Emory Orthopaedics & Spine Center is to lead the comparison of traditional cortisone injection outcomes to outcomes using stem cell injections from autologous bone marrow concentrate (from the patient’s own bone marrow), manufactured stem cells from umbilical cord tissue, and adipose-derived stem cells (fat-storage cells).
TrialSite News has covered the great promise of stem cells but also the peril many of our community face with non-FDA approved clinics operating throughout the country. This study is landmark; it reflects a confluence of interests, expertise and subject matter of societal-level importance.
The Marcus Foundation-funded clinical trial has commenced. The sponsor, Emory University, describes the study as a multicenter trial conducted to compare the effectiveness of corticosteroid control to mesenchymal stem cell preparations from autologous bone marrow concentrate (BMAC), adipose derived stem cells in the form of Stromal Vascular Fraction (SVF), and third party human mesenchymal stem cells manufactured from umbilical cord tissue (UCT) for the treatment of unilateral Knee Osteoarthritis (OA). The study will be conducted in 4 sites in the United States, including Emory University. A total of 480 participants will be enrolled in this study.
The trial’s design includes two Primary Outcome Measures and two Secondary Outcome Measures.
TrialSite News includes the Principal Site Directors and their contact information should there be interest in participating in this critically important study. We know from reader feedback there is a tremendous amount of pain out there associated with osteoarthritis. This important study will contribute material knowledge to how we can potentially evolve the standard of care for improved outcomes.
Research sites include the following:
Andrews Institute, Joshua G. Hackel, MD 850-916-8783
The Emory Clinic, Kenneth Mautner, MD 404-778-7142
Duke University, Blake Boggess, DO 919-681-9525
Sanford Health (Fargo),Benjamin Noonan 605-312-6020
Sanford Health (Sioux Falls), Chad Kurtenbach, MD 605-312-6020
Scott D. Bowden is the study’s Principal Investigator and Hicham Drissi, PhD, is the Study Director. The study began March 28, 2019 and completes December 31, 2019.
The investigators will collect valuable data which will be utilized as a baseline to help develop new standards of care utilizing stem cell therapies as prospective options for treatment. The existing regimen of non-steroidal alternatives and cortisone injections can cause severe damage with continual use. In this critically important study, Bowden noted “all injected cells will undergo an unprecedented level of sophisticated characterization to identify which donor-patients are more likely to have positive results with their own stem cells and identify critical attributes needed to improve manufactured third party stem cells for equally and consistently effective outcomes.”
An exciting and potentially landmark study: this research team seeks to uncover the opportunity to correlate clinical data with comprehensive characterization of all cells for each patient. This study is occurring just in time. The severe pain many in our elderly population face on a daily basis reflects urgency to the issue. Imagine if stem cell injections could eradicate the harshest symptoms of the disease! This study brings a scientific rigor and methodical coverage to understanding the applied use of stem cells for a pervasive indication in society. Investigator Bowden notes that “while there is much enthusiasm about the regenerative capacity of stem cells, it is important for the science to catch up and we will provide quantitative and qualitative correlations of cell characteristics to clinical outcomes and determine the relative effectiveness and conditions predictive of success of each possible option.”
TrialSite News will be monitoring this landmark study carefully. There are many in our network that struggle with debilitating pain. We applaud the Marcus Foundation and the research team led by Emory and Dr. Bowden.
Scott D Bowden, MD