Umbilical Cord Blood Transplant for Children With Lymphoid Hematological Malignancies (UCALL)
The purpose of this study is to determine the safety and effectiveness of UCBT to treat patients with lymphoid hematological diseases and to see if this treatment can decrease the incidence of leukemia relapse, GVHD and infections. These patients have a type of blood cell disorder that is very hard to cure. This treatment that is being used in this trial is known as a stem cell transplant. This treatment might help the patient live longer without the disease. It uses much stronger doses of drugs and radiation to kill the diseased cells that could be given without the transplant. We also think that the healthy cells from the donor may help fight any diseased cells left after the transplant. For the transplant to take place, we will administer stem cells from a 'donor' whose cells best 'match' the patient's. In this study umbilical cords will be the source of the stem cells. Before the transplant, two very strong drugs plus total body irradiation will be given to as preconditioning. This treatment will kill most of your blood-forming cells in the bone marrow. The patient will then get then healthy stem cells. If the patient has the disease in the central nervous system (CNS), they will receive radiation to the head and spine before starting the conditioning. This is to try to get disease control in the CNS. Radiation will not be given for children under 2 yrs old. Currently, many umbilical cord blood units are available in public banks for transplantation in patients lacking bone marrow donors. UCB transplants (UCBT) may offer several advantages over adult bone marrow or peripheral blood stem cell transplants, including: 1. rapid availability, 2. absence of donor risk, 3. low risk of transmissible infectious diseases, 4. low risk of acute GvHD (Graft vs. Host Disease) The three main causes of death after umbilical cord blood transplantation for these kind of disorders are graft failure, infection and disease relapse. In this study we are trying to address these three problems: To help improve engraftment we will add the drug Fludarabine to Cytoxan and total body irradiation. Fludarabine is a very strong medicine. We will try to decrease infections and reduce leukemia relapse by using fludarabine instead of antithymocyte globulin (ATG).
NCT01247688 — Lymphoid Hematological Malignancies
Status: Withdrawn
http://inclinicaltrials.com/lymphoid-hematological-malignancies/NCT01247688/
Allogenic Transplantation of Ex-vivo Expanded CB Progenitors for Haematological Disorders
The aim of this study is to evaluate the safety profile and tolerability of infusion of cord blood cells expanded in the lab and to evaluated whether through the infusion of expanded cells it is possible to expedite engraftment time after transplantation.
NCT01235468 — Hematological Malignancies
Status: Withdrawn
http://inclinicaltrials.com/hematological-malignancies/NCT01235468/
Pilot Phase. Cord Blood Serum in the Treatment of Ocular Surface Diseases
Human autologous serum (AS) eye drops have been successfully used in the treatment of severe ocular surface disorders and the enhancement of corneal wound healing, due to their growth factor (GF) content. Umbilical cord serum (UCS) contains even higher GF concentrations and the objective of the study was to prove whether UCS eye drops 1. are effective in the healing of corneal epithelial defects. 2. ameliorate the painful subjective symptoms
NCT01234623 — Graft vs Host Disease
Status: Completed
http://inclinicaltrials.com/graft-vs-host-disease/NCT01234623/
Double-blind Randomized Controlled Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Allogenic Umbilical Cord Blood and Erythropoietin for Children With Cerebral Palsy
This randomized control study is aimed to determine efficacy of umbilical cord blood and erythropoietin combination therapy for children with cerebral palsy.
NCT01193660 — Cerebral Palsy
Status: Completed
http://inclinicaltrials.com/cerebral-palsy/NCT01193660/
Optimization of the T Regulatory Cell and T Effector Cell Doses in Recipients of Double UCB Transplantation for Treatment of Hematological Malignancies
This is a unique dose-escalation trial that will titrate doses of umbilical cord blood (UCB) Treg and CD3+ Teff cells with the goal of infusing as many CD3+ Teff cells as possible without conferring grade II-IV acute graft-versus-host disease (GVHD). In this study, the investigators propose to add UCB Treg and UCB CD3+ Teff cells to the two TCD UCB donor units with the goal of transplanting as many CD3+ Teff cells as possible without reintroducing risk of acute GVHD. The investigators hypothesize that Treg will permit the reintroduction of CD3+ Teff cells that will provide a bridge while awaiting HSC T cell recovery long term. The co-infusion of Treg will prevent GVHD without the need for prolonged pharmacologic immunosuppression.
NCT01163201 — Acute Myeloid Leukemia
Status: Withdrawn
http://inclinicaltrials.com/acute-myeloid-leukemia/NCT01163201/
In this prospective, cross-sectional study, the aim was to investigate the possible role of cord stress hormones; adrenocorticotropic hormone (ACTH), cortisol, epinephrine, sT3, sT4, and thyroid-stimulating hormone (TSH) in the development of Transient Tachypnea of the Newborn (TTN), via their modulatory effect on epithelial sodium channels and Na-K-ATPase.
NCT01149928 — Wet Lung
Status: Completed
http://inclinicaltrials.com/wet-lung/NCT01149928/
Is Autologous Umbilical Cord Blood Reinfusion Beneficial in Children With Cerebral Palsy: A Randomized, Blinded, Placebo-Controlled, Crossover Study
The purpose of this study is to determine the efficacy of a single intravenous infusion of autologous umbilical cord blood (UCB) for the treatment of pediatric patients with spastic cerebral palsy.
NCT01147653 — Cerebral Palsy
Status: Completed
http://inclinicaltrials.com/cerebral-palsy/NCT01147653/
Autologous Umbilical Cord Blood Transfusion for Preterm and Low Birth Weight Neonates: A Pilot Feasibility Study
This is a pilot study to test feasibility of collection, preparation and infusion of a baby's own (autologous) umbilical cord blood in the first 14 days after birth if the baby is born premature <35 weeks of gestation.
NCT01121328 — Respiratory Distress Syndrome
Status: Withdrawn
http://inclinicaltrials.com/respiratory-distress-syndrome/NCT01121328/
Placenta and Cord Blood Analyses
The purpose of this study is to standardize methods in collecting and processing placenta, umbilical cord and cord blood samples. Samples will be used to determine potential differences between normal weight, overweight and obese individuals.
NCT01104454 — Healthy
Status: Completed
http://inclinicaltrials.com/healthy/NCT01104454/
Umbilical Cord Blood (UCB) Allogeneic Stem Cell Transplant for Hematologic Malignancies
RATIONALE: Giving chemotherapy before a donor umbilical cord blood transplant (UCBT) helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from an unrelated donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor umbilical cord blood stem cell transplant works in treating patients with hematologic malignancies.
NCT01093586 — Chronic Myelomonocytic Leukemia
Status: Completed
http://inclinicaltrials.com/chronic-myelomonocytic-leukemia/NCT01093586/