Rheumatoid Arthritis Stem Cell Studies

Rheumatoid arthritis is an autoimmune disease common in middle age, especially in women. The disease affects peripheral joints, including the wrists, feet, ankles, and knees. The cause is unknown and eyes and skin also can be involved. Early aggressive therapy with immunosuppressive drugs and anti-inflammatories appears to delay joint destruction.

Joint inflammation is a hallmark of rheumatoid arthritis. That includes: Stiffness, Swelling, Pain, Redness and Warmth, Fatigue, Malaise, Loss of Appetite and Muscle Aches.

Stem cells are unprogrammed cells in the human body that can be described as "shape shifters." These cells have the ability to change or “differentiate” into other types of cells. Stem cells are at the center of a new field of science called regenerative medicine. Because stem cells can become bone, muscle, cartilage and other specialized types of cells, they have the potential to treat many diseases, including Parkinson's, Alzheimer's, Diabetes and more.

StemGenex offers stem cell therapy using Adult stem cells only. There are four known types of stem cells:

• Adult Stem Cells - derived from the adult human body
  The use of adult stem cells in research and therapy is not as controversial as the use of embryonic stem cells, because the production of adult stem cells does not require the destruction of an embryo. Additionally, in instances where adult stem cells are obtained from the intended recipient, the risk of rejection is essentially non-existent. Consequently, more US government funding is being provided for adult stem cell research. This is why StemGenex offers stem cell studies using Adult stem cells only.
• Embryonic Stem Cells - derived from embryos
  These cells require specific signals to differentiate to the desired cell type. If they are simply injected directly, they will differentiate into many different types of cells, resulting in a tumor derived from this abnormal pluripotent cell development (a teratoma). The directed differentiation of ES cells and avoidance of transplant rejection are just two of the hurdles that ES cell researchers still face. StemGenex does not use embryonic stem cells.
• Fetal Stem Cells - derived from aborted fetuses
  Have developed further than embryonic stem cells and are a little more specialized – their options are slightly more limited. However, they can still produce most types of cell in the body. StemGenex does not use fetal stem cells.
• Induced Pluripotent Stem Cells (iPSCs) - from some parts of the human body
  These stem cells are engineered from older, fully specialized cells – for example, skin cells, which are limited naturally to being only skin cells. Scientists encourage these limited cells to act like embryonic stem cells again, with the ability to become any type of human cell. This is a complex technique that has only recently been developed and is the subject of much ongoing research. StemGenex does not use induced pluripotent stem cells.

Stem cell therapy is an intervention strategy that introduces new adult stem cells into damaged tissue in order to treat disease or injury. Many medical researchers believe that stem cell treatments have the potential to change the face of human disease and alleviate suffering. The ability of stem cells to self-renew and give rise to subsequent generations with variable degrees of differentiation capacities, offers significant potential for generation of tissues that can potentially replace diseases and damaged areas in the body, with minimal risk of rejection and side effects.

Currently, RA is treated with immune suppressive agents such as steroids, methothrexate, cyclosporine, gold, and more recently infliximab (Remicade). Despite inducing temporary improvement, these approaches possess long-term adverse effects due to non-specific inhibition of immune responses. Additionally, current treatments do not address the issue of damage that has already occurred to the joints or extra-articular tissues.

StemGenex is currently studying the effect of adult stem cell therapy on patients diagnosed with Rheumatiod Arthritis. Because Rheumatoid Arthritis complications include inflammation and tissue damage adult stem cells may target inflamed areas of the body and produce anti-inflammatory agents. StemGenex is also studying the stem cells ability to produce Regulatory T cells, a type of immune cell whose responsibility is to regulate the immune system while maintaining tolerance to self-antigens. By differentiating into these types of healthy cells StemGenex hopes that adult mesenchymal cells will be able to address the complications caused by Rheumatoid Arthritis.

StemGenex is studying potential ways to directly target the conditions and complications themselves. These studies consist of multiple ways to deliver the highest amount of activated stem cells to the areas patients need them most. When stem cells are studied through StemGenex, as potential therapy for Rheumatoid Arthritis, there are multiple ways they can be administered:

• Full body IV – directed into the vein
• Intra Nasal – administration to access a highly vascular pathway of the nose to encourage more stem cells to travel past the blood brain barr
• Direct site injections – injected directly into the site that needs repair, i.e., muscles and tendons

Yes. Scientists around the world believe there is enough evidence to suggest that stem cells hold real potential as a therapy for Rheumatoid Arthritis. This evidence comes from a multitude of early clinical studies. They believe that it is now time for a concerted effort in stem cell research and an international effort to support clinical studies of stem cells for Rheumatoid Arthritis.

No. There are currently no FDA approved stem cell therapies for Rheumatoid Arthritis. All stem cell therapies for Rheumatoid Arthritis are currently ‘unproven’, ‘experimental’ therapies. This means that the FDA does not know whether stem cells are effective for people with Rheumatoid Arthritis. The only way to determine the effectiveness of stem cell therapy is through the type of clinical studies and trials which are currently being conducted in the US.

One of the goals of StemGenex, through our stem cell studies, is to understand what a particular stem cell therapy might be able to achieve. For example, does it have the potential for slowing the disease's progression, replacing damaged cells and memories, or both? With this goal in mind, StemGenex continues to study these diseases and the full effect of stem cell therapy on each disease. Anecdotally, these results have been overwhelmingly positive but there is more that needs to be done to determine the exact effectiveness of these therapies.

After stem cells have been administered into someone’s body they have to make their way to the correct place (e.g. area of damage) and then have their desired effect. This process takes time and although it is difficult to predict exactly how long, it is likely that it will take several weeks or months on average to see the full desired effect.

Yes, a stem cell therapy may be repeated. Current studies indicate the strong possibility of a cumulative effect from multiple stem cell therapies a patient received for their condition. Long-term studies will attempt to better understand this in detail.

We don’t know yet. This will not be studied in early clinical trials, as this would make it very difficult to measure the true effects of the stem cell therapy. However, a combination therapy may be effective for Rheumatoid Arthritis and is likely to be studied in the future.