Ready or Not...Here we come!

The long awaited day has finally come.

Thank you for all your prayers and support.

Kirk, Kennedy, Grandma Deb and I are headed to North Carolina. We leave on December 2nd and return the 8th.

Kennedy is participating in an extended protocol of a Duke University Medical Center research study. On Tuesday, Kennedy will have a physical and full medical history review. On Wednesday, she will have the stem cell infusion.

Information from Duke...
"On the day of infusion, the cord blood cells will be thawed, washed, and transported to the Pediatric clinic for your child’s infusion under the supervision of the research team and/or clinic staff. Your child will have an IV (intravenous) placed in his/her arm, hand, foot or leg either by the research team or clinical staff. Some children may require numbing cream and/or intranasal or oral Midazolam (Versed) prior to IV placement. The midazolam may be given to help your child relax prior to having the IV placed. Prior to the infusion of cells pre-medications will be given: Benadryl and Solumedrol will be given through your child’s IV and Tylenol will be given by mouth (if your child is able to take). The Benadryl and Solumedrol are given to help prevent your child from having an allergic reaction to the cord blood infusion. The cord blood will be infused over approximately 5-15 minutes. Your child will receive IV fluids after the cord blood infusion and will be observed in the clinic for a minimum of one hour after the infusion. Your child will be able to leave the clinic after at least one hour after the umbilical cord blood infusion, providing your child’s blood pressure, oxygen, heart rate and breathing are at their baseline, your child is awake, taking liquids by mouth, and no reactions noted."

The following excerpt was taken directly from the research information.

WHY IS THIS STUDY BEING DONE?
The purpose of this study is to enable access to autologous (their own) or sibling umbilical cord blood (UCB) for children with various brain disorders. Children with cerebral palsy, hypoxic brain injuries, stroke, congenital hydrocephalus, apraxia, autism and other related brain injuries will be eligible if they do not qualify for or are unable to participate in another active clinical trial at Duke. Children with qualifying partially or fully matched sibling or autologous cord blood units will be eligible.

The use of UCB in this fashion is based on safety and efficacy data from prior and ongoing clinical trials at Duke University Medical Center in patients with these diagnoses who were infused with autologous or sibling UCB over the past decade. The majority of these infusions have been in children using their own cord blood. Of note, the UCB is infused intravenously (through an infusion into your child’s vein) in the outpatient clinic without prior or post-infusion immunosuppression (medicine to prevent the body from rejecting the UCB).

Blood cells produced in a fetus before birth circulate through the fetus’s body, umbilical cord, and placenta throughout pregnancy. The blood cells circulating from the baby through the placenta and back again bring oxygen and nutrition from the mother to the baby. When the baby is born, the umbilical cord is cut and the baby is separated from the placenta and the mother. The placenta, or “afterbirth,” is delivered several minutes later and is usually thrown away. The placenta contains one-third to one-half of a cup of residual blood from the baby, which is rich in many types of cells. These cells can be collected shortly after birth and frozen in qualified laboratories (cord blood banks) for potential future use. These cells, referred to as “umbilical cord blood” could be used to replace the blood cells in a person who has leukemia, bone marrow failure, sickle disease, or a rare inherited disease. Because the goal of this use of cord blood cells is to replace abnormal cells, in these situations, patients are treated with high doses of chemotherapy and or radiation therapy before undergoing blood stem cell, or umbilical cord blood, transplantation.

Umbilical cord blood also contains cells that instruct the body to repair damaged organs and tissues, and not replace abnormal cells. For this reason, umbilical cord blood infusions have been tested in children and adults with various brain injuries without giving high doses of chemotherapy and or radiation therapy . While early results have demonstrated potential for benefit, the use of umbilical cord blood infusions to treat brain injuries is considered to be investigational. The word “investigational” means the study product is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA). While additional clinical trials are conducted, some children will not be eligible for those studies. This expanded access protocol was developed to provide access to autologous cord blood cells or cord blood cells from a sibling for these patients. The purpose of this study is to collect additional information about the safety of autologous or sibling cord blood cell infusions in these patients.

Additional Information:

Stem cells: What are they and what do they do?


Thank you for your support and prayers. Please continue to remember us as it takes time for the cells to repair the damaged tissue. We will not see progress until a couple of months after the infusion. We will do our best to keep you updated.

Blessings,
Krystal & Kirk