Stem cell therapy for arthritis: A discussion with Dr. Moira Dolan

Background:
Rheumatoid arthritis (RA) is an autoimmune disease that affects about 1.5 million Americans. Treatment can help manage symptoms but there is no established cure for RA. In the past few years, research has shown promising results using adult stem cells taken from autologous adipose tissue for the treatment of inflammatory, degenerative, and autoimmune diseases—including rheumatoid arthritis. In this interview, Dr. Moira Dolan explains how adult stem cell therapy for RA is performed and how patients have fared following treatment.

MDLinx: How are stem cells used for joint regeneration?

Dr. Dolan: Adult stem cells—including mesenchymal stem cells (MSCs)—are repair cells that have been studied for many years in bone marrow, but are also found in many tissues of the body. They are known to “home in” to signals of inflammation in damaged tissue and organs to do their job repairing normal wear and tear on the body. However, aging and degeneration are a failure of those stem cells in the local environment (such as a knee or hip) due to the decreasing numbers and potency of cells as we grow older.

Adipose tissue is a superior source of adult stem cells—researchers have found up to 2,500 times more of these cells (again, including MSCs) in adipose tissue compared with bone marrow. Furthermore, these stem cells require no manipulation, culturing, or expansion and, according to research, appear to be relatively unaffected by age in terms of population and potency.

Although the initial promise of stem cell research was/is that we will be able to re-grow whole joints for transplantation, this is not the case today. In addition to the ability of MSCs to repair and replace damaged cartilage, bone, etc., these cells are known to have a number of paracrine secretions (a form of cell-to-cell communication) that can address widespread inflammation, halt continued premature cell and tissue death, reduce scarring (such as post-surgical scarring), modulate abnormal immune responses, and stimulate the growth of new blood vessels for improved blood flow.

MDLinx: Can you explain the process from the harvesting of cells to their implantation in the patient?

Dr. Dolan: This is a minimally invasive, same-day outpatient procedure with little recovery or down time needed. Before the procedure, our center [Okyanos Cell Therapy in Austin, TX] develops a customized treatment plan based on an assessment of imaging studies and each patient’s medical and surgical history.

For the procedure itself, we first perform water-assisted fat harvesting to obtain about a cup and a half of adipose tissue from the abdominal area. Both stem cells and regenerative cells are separated from the fat tissue and prepared for injection using an EU-approved cell processing device.

The adult stem cells are then immediately delivered intravenously or by direct injection (or both) in accordance with the individualized treatment plan developed for the patient by our medical team.

Response times vary from patient to patient. Some patients report a benefit within the first 4 to 6 weeks post-op, while others report a response at 4 to 6 months. We commonly hear from patients that they experience better function, decreased pain, increased mobility, better sleep quality, and less pain medication dependence. These are indicators of the anti-inflammatory and other paracrine effects of MSCs.

MDLinx: Recent research suggests that MSCs may not be directly replacing damaged areas but rather coordinating the reparative response. Is that a fair assessment of the current understanding of the mechanism of action?

Dr. Dolan: Yes, in fact this is a large part of our patient education process. We want patients to understand that we will not be “curing” their heart disease or arthritis, and we will not be growing them a new knee. What we know is that adult stem cells are capable of encouraging the body’s natural repair mechanisms to address underlying factors associated with chronic, degenerative conditions like arthritis.

MDLinx: Do you have any outcomes data on RA patients?

Dr. Dolan: Though we aren’t a research institute, following the outcomes of our patients and maintaining a relationship with them is very important to us. Anecdotally, we hear from approximately 80% to 90% of our patients that they are experiencing improvement following cell therapy. We are in the process of developing a robust follow-up program that will allow us to publish outcomes reports and will be beneficial to the research community.

MDLinx: Your center performs these procedures outside of the US. What’s the current state of investigation/approval?

Dr. Dolan: Unfortunately, cell therapy is not yet reimbursed by most insurance companies due to the fact that the technology necessary to perform cell therapy is not yet FDA approved.

The current regulatory status in the US bars the non-homologous use of tissue, as well as “more than minimal manipulation” of said tissue. In other words, doctors are allowed to obtain adult stem cells from bone marrow, process them minimally, and re-inject them into joints for certain orthopedic conditions. This presents obvious limitations, not the least of which is potency of the cell product.

All clinics in the US that currently offer adipose stem cell therapies are doing so using inferior technology and outside of the FDA’s current rules on the subject. We don’t see evidence that this therapy will be approved or sufficiently regulated in the US anytime soon, and so have opted to remain in a jurisdiction [Freeport, Grand Bahama Island] where it is safer for both patients and practitioners.

About Dr. Dolan: Moira Dolan, MD, is an internal medicine physician and patient consultant at Okyanos Cell Therapy. She is a diplomate of the American Board of Internal Medicine and is certified by the American Board of Anti-Aging and Regenerative Medicine.