Collection and Storage of Umbilical Cord Blood for Sickle Cell Disease - Protocol Description [NCT 00012545, NIH protocol 01-H-0122]
If you are pregnant and expecting a baby that may have sickle cell disease you might be interested in our research study. We are collecting umbilical cord blood from newborns that may have sickle cell disease and we are freezing the hematopoietic stem cells that are in the cord blood. Hematopoietic stem cells are used in transplant treatment of sickle cell disease; the more cells the doctors use the better the outcome. The goal of our research is to come up with the best ways to harvest, freeze and thaw the stem cells from the umbilical cord blood so when it comes time to use the stem cells for treatment there will be a lot of high quality cells to use.
To be eligible for this program the pregnant mother must be between the ages of 18 - 45 and she must plan to deliver her infant at a hospital in the Washington Metropolitan Area. The pregnant mother needs to attend a meeting with the nurse coordinator in order to go over the program and give consent before labor begins. There is no cost to the family or their insurance carrier for this program.
For further information please contact the Office of Patient Recruitment 1-800-411-1222 or via email at PRPL@cc.nih.gov. Please reference study number NCT 00012545.
Natural History of Sickle Cell Disease – Protocol Description [NCT00081523, NIH protocol 04-H-0161]
This research protocol allows us to evaluate you because you have sickle cell disease. This will help us gain more understanding of your disease, painful attacks and organ complications often associated with the disease. We are looking for a relationship between sickle cell disease and specific variations of certain genes by studying fluid and cells obtained from your blood, tissue, and elsewhere. Samples collected will be used to study the role of genetic risk factors in sickle cell disease. Samples (blood or tissue) and data collected from medically-indicated procedures may be used for research purposes. You will not receive experimental treatment under this protocol.
This study enrolls individuals with sickle cell disease ages 2 and over. Your evaluation may also provide information indicating that you are eligible for another protocol at the NIH. If so, the other protocol will be discussed with you. You are under no obligation to participate.
For further information please contact the Office of Patient Recruitment at 1-800-411-1222 or via email at PRPL@cc.nih.gov. Please reference study number NCT00081523.
Pathophysiology of Acute Pain in Patients with Sickle Cell Disease-Protocol Description [NCT03049475, NIH protocol 17-H-0056]
This research will help our understanding of your sickle cell disease. We want to learn more about painful attacks and complications often associated with this disease. Blood samples collected during an acute painful attack and in between attacks (“steady state”) will be used to study the role of genetics, swelling that is generally painful (inflammation), and blood clotting factors in SCD. We intend to look for a relationship between acute painful attacks and specific changes in your blood. You will not receive experimental treatment under this protocol. This study enrolls individuals with sickle cell disease ages 18 and over.
For further information please contact the Office of Patient Recruitment at 1-800-411-1222 or via email at PRPL@cc.nih.gov. Please reference study number NCT03049475.
Stem Cell Transplant for Sickle Cell Disease - NIH Protocol
If you (or someone you know) have severe sickle cell disease, you may be eligible for a stem cell transplantation procedure at the Clinical Center of the National Institutes of Health (NIH). We are studying low-dose radiation and a new combination of medications to improve transplant results.
You must have a healthy first-degree family member (parent, child, or brother or sister) to participate. The most suitable donor depends on white blood cell (HLA) and red blood cell (ABO) typing.
- Transplant using fully matched donor (03-H-0170, PI: John Tisdale) - Protocol Description: NCT 00061568
- Transplant using fully matched donor, and the patient at high risk for transplant failure or with transfusion difficulties (14-H-0077, PI: Matthew Hsieh) - Protocol Description: NCT 02105766
- Transplant using half matched donor (17-H-0069, PI: Courtney Fitzhugh) – Protocol Description: NCT 03077542
We also have a gene therapy study where we take your own bone marrow stem cells and insert the correct gene. For this study, you are your own donor
- Gene therapy transplant (14-H-0155, PI: John Tisdale) – Protocol Description: NCT 02140554]
We pay for all medical costs related to the transplant procedure. You must be available to live near the NIH for approximately four to six months. A small daily allowance may be provided to help with living expenses while you are on the study and living away from home.
For further information on any of these studies, please contact the Office of Patient Recruitment at 1-800-411-1222 or via email at PRPL@cc.nih.gov. Please reference specific NCT study number as shown above.