StemGenex’s New Rheumatoid Arthritis Clinical Study of Stem Cell Therapy Enrolling

StemGenex’s New Rheumatoid Arthritis Clinical Study of Stem Cell Therapy Enrolling

RA patients are enrolling in a clinical study from StemGenex that looks to harness the power of patient-specific, adipose-derived mesenchymal stem cells (MSCs) for their anti-inflammatory and potentially therapeutic properties.

RA is the most common form of an inflammatory autoimmune arthritis, affecting more than 1.3 million Americans. RA is a chronic (long-term) disease that causes pain, stiffness, swelling and limited motion and function of many joints. While RA can affect any joint, the small joints in the hands and feet tend to be involved most often. RA can have extra-articular manifestations in which inflammation affects organs including the skin, eye, heart, lung, renal, nervous and gastrointestinal systems.

Because of this, StemGenex is conducting a patient-centric observational clinical study using autologous adipose-derived stem cells in patients with rheumatoid arthritis. The cells, which are taken from a patient’s own stromal vascular fraction (SVF), are isolated during a surgical procedure conducted at StemGenex’s facility in California. According to the study design, patients will be monitored for pain and functionality over the course of a year following treatment.  “I am excited to be part of a study that investigates enhancing the body’s innate ability to regulate and heal itself,” said Dr. Andre P. Lallande, Principal Investigator of the studies.

To receive the best care possible, patients in the study travel to California for three days at StemGenex’s treatment facility. A consultation on the first day, a surgical procedure on the second day, and a follow-up consultation on the third day complete the trip. The surgical procedure consists of cell isolation, activation, and re-administration, where the cells are administered via full body intravenous injection, and site-specific injections. Afterward, patients are monitored for changes in disease activity using the Patient Activity Scale-II (PAS-II). This outcome measure includes 12 questions concerning the ability to conduct daily activities (e.g., “Are you able to stand up from a straight chair?”) and the pain associated with activities (e.g., “How much pain have you had because of your illness in the past week?”). Patients are evaluated regularly for one year to identify any significant changes from baseline. As secondary outcomes, the same scale is used to determine changes in overall pain and overall global activity, and a separate scale (Participants’ Response to the Health Assessment Questionnaire-II [HAQ-II]) is used to determine changes in overall health. Fifty patients are expected to enroll in this study.

One rheumatoid arthritis patient, Georgi Crocker, a 43-year-old pharmaceutical sales representative, has already had a positive experience with this investigational stem cell therapy. When Crocker began suffering from the symptoms of rheumatoid arthritis (swollen joints, fluid retention, and weight gain), she started taking common pharmaceuticals to treat rheumatoid arthritis (Enbrel®, Humira®, Simponi®, and Orencia®) but to no avail. “I would get frustrated and stop taking a drug, like Humira®, but once you stop a drug in the same class you can’t go back to it because your body produces antibodies to it. Then the drug either doesn’t work at all or you can have serious reactions,” said Crocker. Feeling hopeless, Crocker began looking into cell-based therapies and discovered StemGenex in her searches. Intrigued, Crocker and her newly-wed husband looked deeper into the treatment and became convinced when she saw that the founder and CEO of StemGenex, Rita Alexander, had rheumatoid arthritis. “Rita was a big factor,” recalled Crocker. “Here was someone with the same condition as me, who has had tremendous success with adipose adult stem cell treatment.” After Crocker underwent treatment, she saw results within a week: her blood markers of inflammation had decreased, and she could see her knuckles again.

StemGenex indicates that adipose-derived MSCs may have a therapeutic effect in patients with rheumatoid arthritis because the cells have immunomodulatory properties. The cells target areas of inflammation in the body and produce anti-inflammatory agents to attenuate inflammation in joints. Still in exploration is the possibility that these cells also produce regulatory T-cells (T-regs). T-regs could be important in managing rheumatoid arthritis because they keep the immune system in check while maintaining tolerance to self-antigens.

An article published in Stem Cells, “Human Adipose-Derived Mesenchymal Stem Cells Modulate Experimental Autoimmune Arthritis by Modifying Early Adaptive T Cell Responses,” describes how MSCs can attenuate rheumatoid arthritis apparently through T-reg immunomodulation. During the study, researchers induced rheumatoid arthritis in mice and injected human adipose-derived MSCs in a single dose. Soon after receiving the stem cells researchers observed a reduction in rheumatoid arthritis disease activity and the level of damaging T-cells, but an increase in T-regs, especially T-regs that produce anti-inflammatory interleukin-10 in draining lymph nodes. “All these cellular responses, ultimately, lead to the reestablishment of the regulatory/inflammatory balance in the draining lymph nodes,” concluded the authors.

Dr. Mark Youssef, Co-Investigator of the StemGenex Clinical Study stated, “We are confident that our research on Stem cell treatments for RA will show the therapeutic benefits that have already been shown in these animal model studies. We will also be looking at how ADSC treatments affect inflammatory markers that are typically measured laboratory tests for RA patients.”

Additional evidence that corresponds with the work conducted by StemGenex researchers comes from the First Department of Internal Medicine in Kitakyushu, Japan. At the School of Medicine, Dr. Yoshiya Tanaka, MD, PhD, has been studying “Human Mesenchymal Stem Cells as a Tool for Joint Repair in Rheumatoid Arthritis.” According to the study, published in Clinical and Experimental Rheumatology, MSCs are able to differentiate into cell types that can repair bone surfaces damaged by inflammatory conditions, prevent the creation of cells that induce the damage to bone, and attenuate existing inflammation. This group has also looked at alternative methods of delivering cells: instead of using injections, Dr. Tanaka has studied implanted nano-fibre scaffolds in animal models of rheumatoid arthritis.

There are evidently many ways adipose-derived MSCs may be proposed to act in reducing rheumatoid arthritis. Treatment regimens are being developed in a clinical setting, and studied by researchers such as StemGenex doing this observational clinical study.

It is estimated the current StemGenex study, initiated in January 2015, will have primary results collected in January 2018 for researchers at StemGenex to use in determining if future clinical trials are warranted.

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