Efficiency Evaluation of Allogenic Umbilical Cord Blood (UCB) Transfusion in Patients With Autism
Autism is one of those disorders in Autism spectrum disorders (ASD), which characterized by social interaction abnormalities, impaired verbal and non-verbal communication, and repetitive, obsessive behavior, while the therapeutic effect of current treatments remains limited progress. The possible reason for ASD is neural hypoperfusion and immune deregulation. The Human Umbilical Cord Blood Mononuclear Cells (hUCB-MNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy. In this study, the safety and efficacy of hUCB-MNCs infusion will be evaluated in patients with Autism.
NCT03786744 — Autism Spectrum Disorder
Status: Completed
http://inclinicaltrials.com/autism-spectrum-disorder/NCT03786744/
Fetal Hemoglobin Levels and Umbilical Cord or Adult Blood RBC Transfusions in Preterm Neonates.
Repeated transfusions have been associated with very poor outcome of preterm infants. Fetal hemoglobin (HbF) and adult Hb (HbA) have different affinity for oxygen. The high level of adult Hb may contribute to exacerbating the oxidative damage responsible for prematurity diseases. The investigators hypothesized that transfusing red blood cells (RBC) obtained from allogeneic cord blood (CB) of healthy full-term babies (which contains almost exclusively HbF) may prevent the non-physiological decrease of HbF in premature neonates, likewise protecting them from oxygen radical diseases. Cord blood transfusion in preterms - CB TRIP - is a monocentric prospective nonrandomized study aimed to monitor HbF levels in preterm neonates receiving RBC transfusions from either umbilical blood of full-term healthy babies (CB-RBC) and/or from adult donors (A-RBC).
NCT03764813 — Transfusion Related Complication
Status: Completed
http://inclinicaltrials.com/transfusion-related-complication/NCT03764813/
Safety of Autologous Cord Blood Cells for Preterm Infants.
To assess the safety of autologous volume- and red blood cell (RBC)-reduced non-cryopreserved umbilical cord blood (UCB) cell infusion to preterm infants.
NCT03760900 — Safety Issues
Status: Completed
http://inclinicaltrials.com/safety-issues/NCT03760900/
Evaluation of the Safety and Efficacy of HPC, Cord Blood
This is a phase one study investigating the safety and efficacy profile of allogeneic cord blood hematopoietic progenitor cells (HPC, Cord Blood), when administered by intravenous infusion and intrathecal injection, in subjects who have sustained an acute ischemic stroke within the past 9 days. Treatment period consisting of 3 sessions of both intravenous infusion and intrathecal injection (or intravenous infusion in conjunction with mannitol for subjects unable to tolerate intrathecal injection). Follow-up phone calls for adverse event (AE) assessment will be conducted at 1 week, 1 month, and 2 months after the first intravenous/intrathecal treatment. A follow up clinic visit at 3 months, 6 months and 12 months will include a neurological exam, MRI, and clinical laboratory tests/urinalysis.
NCT03735277 — Acute Ischemic Stroke
Status: Not yet recruiting
http://inclinicaltrials.com/acute-ischemic-stroke/NCT03735277/
The Treatment of Premature Infants With Brain Injury by Autologous Umbilical Cord Blood Stem Cells
To study the safety and effect of autologous umbilical cord blood stem cells for treatment brain injury
NCT03696745 — Safety Issues
Status: Not yet recruiting
http://inclinicaltrials.com/safety-issues/NCT03696745/
Recombinant Human Interleukin-7 (CYT107) to Promote T-Cell Recovery After Cord Blood Transplantation
Participant is being asked to take part in this study because participant received an umbilical cord blood transplant as part of participant's standard treatment. Umbilical cord blood is a source of blood-forming cells that can be used for transplantation, also known as a graft. The problem with this type of transplant is the small number of blood-forming cells available in cord blood transplants, which may delay the "take" of the graft in the transplant recipient. There are 2 parts to this study. The goal of Part 1 of this clinical research study is to learn if it is safe and practical to give recombinant human interleukin-7 (CYT107) to patients who have received a cord blood transplant. Researchers want to learn if CYT107 affects the "take" of the graft and the recovery of certain blood cells related to the immune system (called T-cells, NK cells, and B cells) in patients who have had a cord blood transplant. The goal of Part 2 of this study is to learn if CYT107 may prevent or reduce the effects of graft-versus host disease (GVHD) or the likelihood of developing infections (such as cytomegalovirus [CMV], Epstein-Barr virus [EBV], and BK virus). GVHD happens when transplanted donor tissue attacks the tissues of the recipient's body. This is an investigational study. CYT107 is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how CYT107 is designed to work. Up to 34 participants will be enrolled in this study. All will take part at MD Anderson.
NCT03600896 — Umbilical Cord Blood Transplant
Status: Withdrawn
http://inclinicaltrials.com/umbilical-cord-blood-transplant/NCT03600896/
Pilot Study to Assess the Efficacy of Autologous Umbilical Cord Blood Treatment of Brain and Heart Injury in Neonates With Congenital Heart Defect
The aim of the study is to evaluate the feasibility and safety and efficacy of collecting and infusing autologous umbilical cord blood (UCB) in newborn infants with hypoplastic left heart syndrome (HLHS) and transposition of great arteries (TGA). Rationale: Neonates with HLHS and TGA have significant brain injury as demonstrated by peri-surgical MRI. Moreover, there a substantial tendency to suffer from chronic cardiac condition as low cardiac output state and valvular insufficiency. Treatment of neonates after hypoxic ischemic injury at birth with autologous UCB was shown to safe and improved developmental outcome. The effect of UCB is most likely achieved by reduction of free radicals injury and pro-inflammatory and apoptotic process. Hypothesis: Treatment with UCB immediately after the first cardiac surgey, with in the first week life will reduce the brain injury demonstrated by MRI and reduce the choronic cardiac problems
NCT03558269 — Congenital Heart Disease
Status: Recruiting
http://inclinicaltrials.com/congenital-heart-disease/NCT03558269/
Umbilical Cord Blood Mononuclear Cells for Hypoxic Neurologic Injury in Infants With Congenital Diaphragmatic Hernia (CDH)
The purpose of this study is to investigate the use of autologous umbilical cord blood (UCB) mononuclear cells to mitigate hypoxic neurologic injury among infants with high-risk congenital diaphragmatic hernia (CDH).
NCT03526588 — Congenital Diaphragmatic Hernia
Status: Recruiting
http://inclinicaltrials.com/congenital-diaphragmatic-hernia/NCT03526588/
A Phase 1 Open-Label, Multi-Center Trial of AB-110 in Adults With Hematologic Malignancies Undergoing Cord
A phase 1b, open label, multi-center trial of AB-110 in adults with hematologic malignancies, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplasia (MDS) undergoing cord blood transplantation. Subjects will receive unmanipulated cord blood (UCB) and AB-110 expanded CD34 enriched hematopoietic progenitor cells (HSPC).
NCT03483324 — Acute Myeloid Leukemia
Status: Completed
http://inclinicaltrials.com/acute-myeloid-leukemia/NCT03483324/
A Phase I-II Open-label Study of Reduced Intensity-allogeneic Transplant of ECT-001 (UM171/ Fed-batch Culture System) Expanded Cord Blood in Patients With High-risk Multiple Myeloma
Multiple Myeloma (MM) is a morbid disease associated with a poor outcome and while current therapies with new drugs have improved survival, MM still remains incurable in most patients. The only potential curative treatment remains allogeneic Hematopoietic stem cell transplant (HSCT), as shown by our cohort of 92 newly diagnosed patients who received a sibling tandem auto-allo (HSCT) with an estimated 10-year progression free survival (PFS) of 43%. However, the high incidences of toxicities including chronic graft-versus-host-disease (GVHD) (up to 79%) and disease progression (up to 49%) impair improvement in cure rate. Using umbilical cord blood (CB) as an alternative source of hematopoietic stem cells (HSC) could be superior biologically because of their increased proliferative capacity, greater number of progeny with longer telomeres and better anti-tumor efficacy in presence of positive residual disease. Moreover, using CB has been shown to decrease incidence of chronic GVHD. However, CBs have the disadvantage of having a limited HSC dose leading to prolonged cytopenia and higher risk of infections. In a first in-human trial using CB expanded with the ECT-001 (UM171) molecule (clinicaltrial.gov # NCT02668315), the median net expansion of HSC was 36 fold, which allows for the selection of better HLA matched CB regardless of their lower HSC dose. Moreover, the ECT-001 expanded CBs have a different cell composition than regular CBs, with more than 25% of dendritic cell precursors. This, combined to better HLA matched CBs, may reduce chronic GVHD incidence and improve immune reconstitution. To date, 22 patients received an ECT-001 expanded CB and the procedure proved to be safe and feasible. In this new trial, the goal is to evaluate the safety and efficacy of ECT-001 expanded CB transplant in high risk MM patients.
NCT03441958 — Multiple Myeloma
Status: Active, not recruiting
http://inclinicaltrials.com/multiple-myeloma/NCT03441958/