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VITROBIOPHARMA MESENCHYMAL STEM CELL INFUSION IN ANTIGUA

ABOUT VITROBIOPHARMA: We inject locally or infuse intravenously mesenchymal stem cells (MSC) from VBP, Vitro Biopharma (vitrobiopharma.com) in Golden Colorado. They are cGMP, FDA registered, 9001 and 13485 internationally ISO certified lab and, in my opinion, produce the highest quality stem cells in the world. These are NOT fetal or embryonic. Rather ladies donate their umbilical cords after term Cesarean Section deliveries. After testing the stem cells are isolated from the umbilical cord Wharton’s jelly, expanded in culture and cryopreserved at minus 196 degrees in liquid nitrogen. Every month our necessary quantity of cells are flown by special courier under strict temperature control to Antigua where they continue to be stored in liquid nitrogen until they are ready for use.

STEM CELL PROTOCOL: When a patient is ready for treatment in the medical surgical associates medical center in Antigua an IV is started. Then the stem cells for that patient are removed from their liquid nitrogen freezer and carefully thawed and drawn into a syringe in a laminar flow hood using strict sterile technique by an experienced member of our team. They are then ready for intravenous infusion or for local injection. Injections into joints are carried out by board certified surgeon Chadwick Prodromos MD. Injections into the back, neck or scalp are carried out by world renowned pain specialist Ken Candido MD. Injections into the penis or pelvic floor are carried out by experienced urologist Adrian Rhudd.

DISORDERS TREATED In the “What We Treat” link is a list of the most common disorders we treat with an indication as to whether we treat with VPB MSCs or T cell vaccine or Effector Cells. For some disorders there is more than one option.

T CELL VACCINE (TCV) FOR THE TREATMENT OF AUTOIMMUNE DISORDERS IN BUENOS AIRES AND ANTIGUA

We are able to treat and often eliminate autoimmune disorders such as MS, Scleroderma, and Type 1 diabetes using this technique. The only other treatment which can eliminate autoimmune disease requires destruction of the patient’s immune system with toxic chemotherapeutic drugs with severe complications and occasionally death while the immune system is re-established. In contrast the TCV has no serious side effects and uses no drugs, only the patient’s own cells.

THEORY OF T CELL VACCINE TREATMENT: In autoimmune disorders rogue immune cells attack the patient. These may be T cells directly or B cells indirectly through antibodies. The T cell vaccine is created by using apheresis (see below) to identify and remove some of these rogue cells. They are then treated and killed and re-infused intravenously. They induce the body’s immune system to disarm these rogue cells by generating a colony of T regulatory cells so that these rogue cells no longer attack the patient.

APHERESIS: The patient has apheresis in Buenos Aires Argentina. This involves a catheter being put in an arm vein or the femoral vein in the groin. Blood is removed and replaced over about 2.5 hours, with a small percentage of the patient’s lymphocytes (a type of white blood cell) being removed. This removal produces no problem for the patient and is painless except for the minor discomfort of starting the IV. The rogue cells are identified and isolated for creation of the TCV.

CREATION OF THE VACCINE: The rogue lymphocytes are treated for a week and then killed thus creating a vaccine of cells that can no longer do harm. They are then infused intravenously to begin working.

TYPICAL SCHEDULE: The patient arrives in Buenos Aires on a Sunday. On Monday the patient has apheresis at a special facility. The following Tuesday, 8 days later, the patient receives the first intravenous dose of the T cell vaccine. Most patients feel nothing during or after the infusion. However some patients have transient minor symptoms such as fatigue or low-grade fever. No serious side effects have ever been seen. Minor fatigue is common for 3 weeks after the infusion.

REPEAT TREATMENT: Repeat vaccine doses are carried out 3 -5 week intervals, generally monthly. These repeat doses may be given in Buenos Aires or in the Caribbean in Antigua. In Antigua the patient arrives in the afternoon and may have the vaccine infusion over about an hour in early evening. They may then return home the next day. The infusions generally produce no side effects, although minor fatigue is common for 3 weeks afterward. While the disease may be arrested after only a few vaccine infusions, it is usually recommended that patients have a total of 10 to 12 vaccine doses to prevent recurrence. Long term remissions for decades is the norm after treatment.

TOTAL PLASMA EXCHANGE: If the disease is particularly aggressive and produces severe symptoms of pain and tissue breakdown, for some disorders the apheresis may be combined with total plasma exchange. In this procedure the patient’s plasma, which contains the particles directly causing pain, is removed, discarded and replaced with albumin. This generally produces substantial symptom relief for 4 to 6 weeks. This can serve as a bridge for greater patient comfort while the vaccine is beginning to work.

EFFECTOR/PROGENITOR STEM CELL TREATMENT IN BUENOS AIRES

Using this technique we are able to treat spinal cord injury, stroke, cerebral palsy, eye disorders such as macular degeneration and retinitis pigmentosa, myocardial infarction (heart attack), hearing loss, arthritis with contracture and cartilage loss, and other disorders in which tissue has died and cannot otherwise regenerate. We are able to significantly regenerate this tissue. There is no other technique currently available which has this capacity.

BACKGROUND: Some types of tissue such as skin or tendon can regenerate after they are damaged. But other types of tissue such as brain, spinal cord, heart, or retina in the eye cannot. If this tissue is damaged and cell death occurs a limited amount of healing occurs within the first two weeks. This early acute and subacute period after injury is called the TH-1 (T helper 1) phase. During this period circulating lymphocytes in your blood are attracted to the damaged tissue and then themselves attract stem cells in your blood to the damaged area. Some healing of the dead tissue occurs by this mechanism between days 5 and 15 after injury. However, after this time the body modulates to a phase of healing called T-helper-2 or TH-2, and scar tissue is laid down over the affected tissue which inhibits the ability of stem cells to get to the tissue and severely limits any further healing.

THEORY BEHIND EFFECTOR CELL TREATMENT: The goal of effector cell treatment is to re-create the TH-1 phase wherein healing of the tissue can occur. Lymphocytes are withdrawn from the patient by apheresis (see below) and then challenged with antigens that mimic the early healing phase so that these lymphocytes develop an affinity for the damaged tissue. They are then injected intravenously and home to the damage tissue and label it and attract stem cells to the area. They also partially diminish the scarring that prevents healing thus enabling the stem cells to begin again to heal the tissue.

STEM CELL HARVEST: The patient is seen in Chicago, or Buenos Aires Argentina, and a small lipo-aspiration procedure is performed to remove a small amount of fat. This is relatively painless and is performed using only local anesthetic in our office. In Chicago patients routinely do this as a day trip arriving in the morning and leaving mid-afternoon. The fat specimen is then shipped to Buenos Aires Argentina. Fat is very rich in stem cells. In Buenos Aires the stem cells are extracted from the fat. They are then expanded in culture and frozen for later use. Prior to the lipo-aspiration one week is required for blood tests to be performed to make sure the stem cells do not carry viruses.

INFUSION OF EFFECTOR CELLS AND STEM CELLS: For brain, spinal cord, heart, the eye, and hearing the effector cells are infused first and the stem cells usually two days later, all intravenously. For joints for arthritis the effector cells and stem cells are injected into the affected joint, not intravenously, and are injected at the same time.

TYPICAL SCHEDULE: The patient arrives in Buenos Aires on a Sunday. On Monday the patient has apheresis at a special facility. On Thursday, for all diagnoses except arthritis, the patient has intravenous infusion of the newly created effector cells. The effector cells are cocultured with the patients stem cells to make progenitor cells. On Saturday the patient has intravenous infusion of the progenitor cells. Patients remain for observation in Buenos Aires on Sunday and then may return home Monday. Most patients feel nothing during or after the infusions however some patients have transient minor symptoms such as fatigue or low-grade fever. No serious side effects have ever been seen.

REPEAT TREATMENT: Benefit is usually apparent two months after treatment. Most patients will need to have the treatment repeated from one to three times more after the initial treatment. The number of potential repeat treatments is variable from patient to patient depending on their response to treatment.