What is Rheumatoid Arthritis?Rheumatoid Arthritis (RA) is an autoimmune disease in which the patient’s immune system generates cellular and antibody responses to various components of the joint such as type I collagen. As a result of this immune response, not only does joint destruction occur, but also other secondary complications such as pulmonary fibrosis, renal damage, and even heart damage.
Can stem cells help rheumatoid arthritis?
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 FDA-approved treatments do not address the issue of damage that has already occurred to the joints or extra-articular tissues.
Advancements in FDA-approved rheumatoid arthritis (RA) treatment protocols and introduction of targeted biological therapies have markedly improved patient outcomes, despite this, up to 50% of RA patients still fail to achieve a significant clinical response.
Stem cell therapy has been demonstrated to induce profound healing activity in animals with various forms of arthritis. For example, the company Vet-Stem routinely utilizes stem cells in horses with various joint deformities to accelerate healing. Besides healing of damaged tissues, stem cells have the unique ability to modulate the immune system so as to shut off pathological responses while preserving ability to fight off disease. Stem cells and specifically, mesenchymal stem cells home to inflamed tissue and start producing anti-inflammatory agents. These mediators act locally and do not suppress the immune response of the patient’s whole body. Additionally, mesenchymal stem cells induce the production of T regulatory cells, a type of immune cell whose function is to protect the body against immunological self-attack.
Which kinds of stem cells are used for rheumatoid arthritis and how are they obtained?
The Stem Cell Institute uses adult stem cells called allogeneic mesenchymal stem cells for rheumatoid arthritis. These cells are harvested from human umbilical cords donated after normal, healthy births. All mothers who donate umbilical cords undergo infectious disease testing and medical history screening. Proper written consent is obtained from each family prior to umbilical cord donation.
All mesenchymal stem cells harvested from umbilical cords are screened for infectious diseases to International Blood Bank Standards before they are cleared for use in clinical investigations.
Only about one in ten umbilical cords pass our rigorous screening process.
What are the advantages of allogeneic human umbilical cord tissue (HUCT)-derived mesenchymal stem cells?
- Allogeneic stem cells can be administered multiple times over the course of days in uniform dosages that contain high cell counts.
- Umbilical cord tissue provides an abundant supply of mesenchymal stem cells.
- No need to collect stem cells through invasive procedures such as liposuction or bone marrow collection
- Anyone can receive them since HUCT mesenchymal stem cells are immune system privileged. Human Leukocyte Antigen (HLA) matching is not necessary.
- There is a growing body of evidence showing that mesenchymal stem cells from umbilical cords are more robust than mesenchymal stem cells from other sources such as fat.
The body’s immune system is unable to recognize human umbilical cord tissue (HUCT)-derived mesenchmyal stem cells as foreign and therefore they are not rejected. HUCT stem cells have been administered thousands of times at the Stem Cell Institute and there has never been a single instance of rejection. Umbilical cord-derived mesenchymal stem cells also proliferate/differentiate more efficiently than “older” cells, such as those found in the fat and therefore, they are considered to be more “potent”.
How are mesenchymal stem cells administered for rheumatoid arthritis?
They are typically given intravenously (IV) over the course of a few days.
Rheumatoid arthritis investigational stem cell treatment: clinical protocol
Below is an example of a 4-day rheumatoid arthritis schedule. Our investigational clinical protocol for RA (www.clinicaltrials.gov NCT01985464) has been approved by the National Institutional Review Board for Clinical Protocols.
- Medical evaluation and blood testing (day 1)
- 2 IV injections of allogeneic umbilical cord mesenchymal stem cells (day 2)
- IV injection of allogeneic umbilical cord mesenchymal stem cells (day 3)
- IV injection of allogeneic umbilical cord mesenchymal stem cells (day 4)
- Medical consult for hormone evaluation
- 1-month supply of Stem Kine supplement (only after medical evaluation in Panama)
What is the difference between a stem cell treatment for rheumatoid arthritis and an investigational treatment under clinical protocol for rheumatoid arthritis?
In Panama the term “stem cell treatment” is reserved for stem cell products that have been approved for use by the Panamanian Ministry of Health (PMH). Before PMH approval, use of these products are referred to as “investigational treatment under clinical protocol” to reflect the fact that they are not yet proven and still under investigation.
At present, we are conducting clinical research and administering investigational treatment under clinical protocols that are reviewed and approved by the National Committee for Bioethics in Research Institutional Review Board (IRB) approval. The IRB reviews all investigational clinical protocols and monitors stem cell research involving human subjects.
In the United States, stem cell treatments are regulated by the Food and Drug administration (FDA). In Europe, the European Medicines Agency holds jurisdiction over stem cell treatments.
Currently, no stem cell treatments for rheumatoid arthritis have been proven safe and effective in the United States, European Union or Panama.
Will anyone follow up with me after I return home?
Proper follow-up enables us to evaluate safety and effectiveness, and improve our clinical protocols based on observed outcomes. Therefore, one of our medical staff will contact you regularly to monitor your progress. We will contact you after 1 month, 3 months, 6 months, and 1 year.
May I speak with someone who has undergone an investigational stem cell treatment?
Yes you may. Several people have volunteered to speak you once you’ve been approved for investigational treatment. Your international coordinator will be happy to put you in touch with them at the appropriate time.
You may also view rheumatoid arthritis news, stories and videos. Please take a look!
How can I contact the Stem Cell Institute?
You may contact us by telephone 1 (800) 980-STEM (toll-free in US) and 1 (954) 358-3382.
To apply, please complete this Application Form.
Antigen Specific Therapy of Rheumatoid Arthritis
Ichim T. Zheng X, Suzuki M, Kubo N, Zhang X, Min L, Beduhn M, Riordan N, Inman R, Min W.
– Expert opin. Biol. Ther. 2008; 8(2): 191-199