A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other Indications
Background: - Cord blood banks have been set up to collect and store umbilical cord blood for transplants. These transplants are used to treat different types of cancer. In October 2011, the Food and Drug Administration (FDA) began considering cord blood as a biological drug. Most of the cord blood units currently available in cord blood banks in the United States and other countries were collected before the FDA set these new standards. The units meet standards set by the National Marrow Donor Program (NMDP), but they were not collected, tested, or stored exactly according to FDA standards. As a result, the new guidelines state that they may only be used for transplant if the transplant is done as part of a study. Researchers have set up a study to provide these cord blood units to recipients and to study the effects of their use. Objectives: - To provide access to cord blood units for recipients whose best choice for a unit meets NMDP but not FDA standards. - To study the effects of these cord blood transplants. Eligibility: - Individuals who need to have a cord blood transplant to treat certain types of cancer. Design: - Participants will be screened with a physical exam, medical history. They will also have blood tests and imaging studies. - Participants will have the cord blood transplant and allow their medical data to be collected by the study researchers.
NCT01479582 — Multiple Myeloma
Status: Withdrawn
http://inclinicaltrials.com/multiple-myeloma/NCT01479582/
Cord Blood Fucosylation to Enhance Homing and Engraftment in Patients With Hematologic Malignancies
The goal of this clinical research study is to learn if it is safe and feasible to transplant changed cord blood for patients with leukemia or lymphoma. Researchers also want to learn if this can help to control the disease. The cord blood will be changed to make use of sugar that is found in small amounts in blood cells. It plays a role in signaling where in the body the transplanted cells should go to. Adding more sugars to the cord blood cells in the laboratory is designed to help the cord blood cells find their way faster to the bone marrow. This may help your blood counts to recover faster. This process is called fucosylation. Anti-thymocyte globulin (ATG) is a protein that removes immune cells that cause damage to the body. Clofarabine is designed to interfere with the growth and development of cancer cells. Fludarabine is designed to interfere with the DNA (genetic material) of cancer cells, which may cause the cancer cells to die. This chemotherapy is also designed to block your body's ability to reject the donor's bone marrow cells. Melphalan and busulfan are designed to bind to the DNA of cells, which may cause cancer cells to die. Mycophenolate mofetil (MMF) and tacrolimus are designed to block the donor cells from growing and spreading in a way that could cause graft versus host disease (GVHD -- a condition in which transplanted tissue attacks the recipient's body). This may help to prevent GVHD. Rituximab is designed to attach to cancer cells, which may cause them to die.
NCT01471067 — Lymphoma
Status: Completed
http://inclinicaltrials.com/lymphoma/NCT01471067/
Body Composition of Infants: Follow-up to Placenta and Cord Blood Analyses
Investigators will characterize the body composition and metabolism of infants born from lean, overweight or obese mothers from whom they had previously obtained a placenta and/or cord blood as part of the earlier placenta and cord blood study (#111576)
NCT01464684 — Infant Body Composition and Metabolism
Status: Withdrawn
http://inclinicaltrials.com/infant-body-composition-and-metabolism/NCT01464684/
The Efficacy and Safety of Allogeneic Umbilical Cord Blood Therapy for Chronic Traumatic Brain Injury Patients
This open label trial is conducted to investigate the efficacy and safety of umbilical cord blood therapy for chronic traumatic brain injury patients. The study hypothesis is that the participants will show significant improvement in cognition and function after Umbilical cord blood (UCB) transplantation.
NCT01451528 — Traumatic Brain Injury
Status: Withdrawn
http://inclinicaltrials.com/traumatic-brain-injury/NCT01451528/
Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units
For the next 5-10 years or possibly longer, a high proportion of the Cord Blood Banks (CBB) inventory worldwide will be composed of unlicensed umbilical cord blood (UCB) units. While Food and Drug Administration (FDA)-licensed units will be prioritized, it will always be possible that an unlicensed unit will have known attributes, making it a better source of cells for the given indication. Because of the wide variety of current and potential indications as a source of cells for hematopoietic reconstitution or other form of cellular therapy, it is critical that the investigators have access to unlicensed UCB units.
NCT01451502 — Lymphatic Diseases
Status: Recruiting
http://inclinicaltrials.com/lymphatic-diseases/NCT01451502/
Autologous Cord Blood Cells for Patients With HLHS: Phase I Study of Feasibility and Safety
Further study details as provided by Duke University: Purpose: To evaluate the feasibility and safety of collecting and infusing autologous umbilical cord blood (UCB) in newborn infants with hypoplastic left heart syndrome (HLHS). Study Rationale and Hypotheses: The major goal of this study is to determine whether infusion of autologous UCB cells in neonates with hypoplastic left heart syndrome is feasible and safe. The rationale for the study and for the potential benefit of UCB is based upon the following hypotheses: 1. Infants with HLHS have significant neural injury evidenced from both prenatal and early antenatal brain MRI findings and infusion of UCB cells may lessen neural injury. Although the exact mechanism is unknown, UCB cell infusion may ameliorate neural injury via paracrine and anti-inflammatory effects that enhance post injury repair and may promote endogenous functional compensation of other cortical areas resulting in significant clinical improvements. 2. UCB cells may also enhance cardiac function, minimize scar formation, and reverse detrimental remodeling after cardiac injury.
NCT01445041 — Hypoplastic Left Heart Syndrome
Status: Terminated
http://inclinicaltrials.com/hypoplastic-left-heart-syndrome/NCT01445041/
An Exploratory Clinical Trial to Assess Treatment of Chronic Ischemic Stroke With Brain Transplants of Purified CD34+ Umbilical Cord Blood Stem Cells
The purpose of the study is to determine the safety and possible effectiveness of brain transplants of CD34+ stem cells obtained from umbilical cord blood (UCB) to treat stroke.
NCT01438593 — Ischemic Stroke
Status: Not yet recruiting
http://inclinicaltrials.com/ischemic-stroke/NCT01438593/
A Phase II Study of Reduced Intensity Double Umbilical Cord Blood Transplantation Using Fludarabine, Melphalan, and Low Dose Total Body Radiation
This trial will use two cord blood units for transplantation using a reduced intensity regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord blood units (double cord blood) are being used, as the numbers of blood cells in one unit are too few to allow successful growth of these cells. Because the risk of infection, particularly virus infection, is high after double cord blood transplant, this study seeks to reduce the rise of virus infection by using a reduced intensity regimen without a medicine called antithymocyte globulin (ATG), as used in prior cord blood transplants. Subjects will receive two chemotherapy drugs, melphalan and fludarabine, and low dose of total body radiation (one treatment) instead of the ATG. The number of patients with virus infections in this study will be compared to our prior experience using the ATG.
NCT01408563 — Multiple Myeloma
Status: Completed
http://inclinicaltrials.com/multiple-myeloma/NCT01408563/
The Telomere System in Cord Blood and in the Placenta in High Risk Pregnancies
The telomere system stabilizes the chromosomes. Telomeres are shortened during senescence, in cases of genetic instability and secondary to stress. The investigators aim is to study the telomere system in cord blood and in the placenta immediately after the delivery in pregnancies defined as high risk pregnancies following sterss events such as placental insufficiency, preeclampsia, diabetes. The investigators intend to compare the telomere system in maternal blood to cord blood and to placental biopsies and to study the influence of different stressogenes on this system.
NCT01384136 — Telomere Length
Status: Active, not recruiting
http://inclinicaltrials.com/telomere-length/NCT01384136/
Donor-Derived, CD19-Specific T Cell Infusion in Patients With B-Lineage Lymphoid Malignancies After Umbilical Cord Blood Transplantation
The goal of this clinical research study is to learn if an infusion of white blood cells (called T cells) that have been genetically changed is safe to give patients who have received an umbilical cord blood transplant (UCBT). Researchers want to learn if these genetically changed T-cells are effective in attacking cancer cells in patients with advanced B-cell lymphoma or leukemia after they have received an UCBT, how long the changed T-cells stay in the body, and if adding them to standard transplant could improve how patients respond to treatment. Funding Source - FDA OOPD
NCT01362452 — Lymphoma
Status: Completed
http://inclinicaltrials.com/lymphoma/NCT01362452/