IMMUNE TOLERANCE INDUCTION
HLA MATCHED LIVING DONOR
KIDNEY AND BONE MARROW TRANSPLANTATION
A Phase 3 Prospective, Randomized, Multi-Center, Open-Label, Controlled Trial to Assess the Efficacy and Safety of Cellular Immunotherapy with MDR-101 for Induction of Immune Tolerance in Recipients of HLA-matched, Living Donor Kidney Transplants.
Funded by: Medeor Therapeutics, Inc.
INFORMATION FOR DONORS
Who can participate? Patients scheduled to donate a kidney with someone that would like to take part in this study.
What is the procedure? The purpose of this study is to determine if a single infusion of MDR-101 can prevent the immune system from rejecting a transplanted kidney without any or minimal anti-rejection drugs. MDR-101 is made form stem cells from the blood of the kidney donor. MDR-101 will be given to the kidney recipient to see if the immune system can be reprogrammed. The study drug MDR-101 has not been approved by the United States Food and Drug Administration (FDA) for kidney transplants and is considered expermiental.
There are several parts to this procedure.
First, you will be given a drug called granulocyte-colony stimulating factor (G-CSF) which causes bone marrow to release large numbers of stem cells into the blood stream. Stem cells are cells that can become all the different cells in the blood. They normally live in the bone marrow in the center of the bones, they are also found in the blood in very small numbers. (G-CSF is approved by the FDA to help in the production of stem cells). You will need to inject this drug under your skin (subcutaneously) with a needle for 5 days in a row in order for this to work.
Then, these stem cells are collected by a special machine called apheresis. The apheresis machine captures the stem cells only and returns the remaining blood product back to the donor. If not enough stem cells are collected then you will be asked to go through a 2nd cycle of G-CSF injections.
What happens during apheresis?
You will have a needle placed into a vein in each arm. From one arm your blood is passed through a tube into an apheresis machine. The machine separates some of the stem cells and white blood cells from the red blood cells, platelets and plasma(the clear yellowish fluid part of the blood). Through the other arm, most of the red blood cells, platelets and plasma will be returned to you. During apheresis, about 5-10 fluid ounces of blood is outside your body. At the end of each session, you to 6 tablespoons of red blood cells and 16 ounces of plasma may have been removed. The apheresis procedure can last between 2 to 4 hours.
Several follow up visits will be required, for which the cost of travel will be reimbursed.
There are additional procedures and risks which are not part of the normal care for donors. You may still choose to donate your kidney to the recipient and not participate in this study. If you decide to participate in this study, your participation will start 2 months before the kidney transplant and finalize 1 month after the surgery. If you will be placed in the Investigational group, you will need to attend up to 6 study visits before the surgery. If in the control group, up to 2 study visits before the surgery.
What are the risks?
•G-CSF risks: Most common complaints reported by healthy people are: bone pain, headache, flu-like symptoms like general feeling of being unwell (malaise), nausea, low-grade fever and night sweats.
* G-CSF less often side effects: muscle pain, sleeplessness, loss of appetite, vomiting.
* Apheresis risks: bruising, infection, fainting, pain at the side of neddle insertion into each arm, numbness or tingling sensation of the lips and fingertips during apheresis.
What are the benefits?
•You may benefit from being closely watched by the study team coordinators and Dr. Witkowski.
•You will help scientists learn how to improve therapy for other patients undergoing kidney transplant in the future.
The decision whether or not you wish to participate in this study will not affect your care at the University of Chicago Medical Center.
Have there been any unexpected complications in the previous study?
No, The risk to the cell and organ donors who participated in the previous study (phase 2) appear to have been minimal and the apheresis required was not associated with significant complications.
Are there any preliminary results indicating potential for success?
The MDR-101 cell product has been already used in the study in limited number of patients (phase 2 study) and found safe and results indicated some effectiveness. Now, it is being tested on a larger group of patients to confirm its effectiveness and safety.