A Phase II Study of IL-6 Receptor Blockade to Ameliorate Acute Graft Versus Host Disease and Early Toxicity After Double Unit Cord Blood Transplantation in Adults With Hematologic Malignancies.
The aim of the research in this study is to make participants' transplant safer by reducing the risk of developing GVHD and GVHD-related complications by giving participants a dose of the drug tocilizumab in addition to the standard approach for GVHD prevention. Tocilizumab reduces the risk of inflammation by blocking the effect of Interleukin-6, a protein that exists in high levels in the blood when there is inflammation. Participants who receive stem cell transplants have high levels of this protein in their blood early after transplant. Therefore, the goal of this study is to reduce the risk of inflammation after transplant with the addition of Tocilizumab. This could decrease the risk of developing GVHD and GVHD-associated complications.
NCT03434730 — Leukemia
Status: Active, not recruiting
http://inclinicaltrials.com/leukemia/NCT03434730/
Safety Study of Autologous Cord Blood Stem Cell Treatment in Hypoplastic Left Heart Syndrome Patients Undergoing the Norwood Heart Operation
This study aims to evaluate the safety and feasibility of coronary infusion of autologous placental cord blood mononuclear cells during the Norwood heart operation in newborn hypoplastic left heart syndrome (HLHS) patients.
NCT03431480 — Heart Defects, Congenital
Status: Completed
http://inclinicaltrials.com/heart-defects-congenital/NCT03431480/
Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries
This protocol is designed to enable access to intravenous infusions of banked umbilical cord blood (CB), that is thawed and not more than minimally manipulated, for children with various brain disorders. Children with cerebral palsy, congenital hydrocephalus, apraxia, stroke, hypoxic brain injury and related conditions will be eligible if they have normal immune function and do not qualify for, have previously participated in, or are unable to participate in an active cell therapy clinical trial at Duke Medicine. For the purpose of this protocol the term children refers to patients less than 26 years of age. Cord blood is administered as a cellular infusion without prior treatment with chemotherapy or immunosuppression. The mechanism of action is through paracrine signaling of cord blood monocytes inducing endogenous cells to repair existing damage.
NCT03327467 — Cerebral Palsy
Status: Available
http://inclinicaltrials.com/cerebral-palsy/NCT03327467/
Determining Overall Improvement in the Quality of Life of Individuals Receiving Human Umbilical Cord Blood Plasma
This study aims to look at whether human umbilical cord blood plasma (HUCBP) is safe for intravascular (iv) administration; and whether it provides any reversal of frailty or other age-related biological measures.
NCT03229785 — Aging
Status: Not yet recruiting
http://inclinicaltrials.com/aging/NCT03229785/
Compare the Q-Cup With Other Umbilical Cord Blood Collection Techniques: A Feasibility Study
Currently there is no standardized method of collecting and transferring umbilical cord blood to laboratory vacuum tubes. Current methods are messy and may require needles to draw the blood presenting risk of blood exposure and percutaneous injury to obstetrical personnel. A safer, more efficient method of collecting cord blood is needed. The investigators propose to use the Q-Cup technology for collecting cord blood. The Q-Cup device is a two-piece injection molded blood collection and transfer device that enables safe and easy collection of blood from the newborn's umbilical cord and readily transfers the blood into a laboratory vacuum tube. The device consists of a collection cup with a wide opening to easily collect blood from the umbilical cord and a guide tube with a recessed needle which is attached to the collection cup. The operator is enabled to fill the required vacuum containing tubes in a clean, quick, efficient and safe manner by simply inserting the vacuum tube into the guide tube of the Q-Cup. As a result, there is less risk of blood exposure and percutaneous injury and blood is collected more efficiently. This device allows the practitioner to collect and transfer umbilical cord blood: without the need for removing the stopper from the vacuum tube (reducing mess and contamination) and without the need for a syringe and exposed needle (reducing injury and infection).
NCT03144180 — Pregnant
Status: Completed
http://inclinicaltrials.com/pregnant/NCT03144180/
To Investigate the Immediate Effect of Birth on Immunological Parameters in Cord Blood, and Compare With Data of CS Born Infants Collected in the JULIUS SN Study
The purpose of the study is to understand the immediate effect of birth on immunological parameters in vaginally born cord blood.
NCT03134768 — Immunologic Activity Alteration
Status: Completed
http://inclinicaltrials.com/immunologic-activity-alteration/NCT03134768/
Mechanism of Allogeneic Umbilical Cord Blood Therapy in Cerebral Palsy
In our prior study on the therapeutic mechanism of UCB, changes in cytokine levels were observed but the results are inconclusive and further studies on animal models and changes of protein expression before and after UCB therapy in the clinical settings are required. The changes in protein expression will be assessed by multiplex RT-PCR mRNA assay. Clinical efficacy of UCB therapy will be evaluated with various functional assessment tools. Factors regarding UCB therapy (number of transplanted cells, HLA matching status, serum level of immunosuppressant, etc.) and patient factors (age, functional status, etc.) will be analyzed for correlation with protein expression after UCB therapy. Several target proteins for analysis are available. Pentraxin and toll-like receptor (TLR) 4 are receptors modulating intrinsic immune reaction and was shown to have a significant correlation with clinical efficacy of stem cell therapy. Ubiquitine is a regulatory protein that combines with the target protein and affects its degradation, interaction, localization and activation. The ubiquitine system controls total protein quantity for homeostasis and can be found in all tissues. Deubiquitination (DUB) enzyme down-regulates this ubiquitine and is known to modulate all cellular changes
NCT03130816 — Cerebral Palsy
Status: Completed
http://inclinicaltrials.com/cerebral-palsy/NCT03130816/
Cord Blood Ex-Vivo MSC Expansion Plus Fucosylation to Enhance Homing and Engraftment
This phase II trial studies how well an umbilical cord blood transplant with added sugar works with chemotherapy and radiation therapy in treating patients with leukemia or lymphoma. Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The umbilical cord blood cells will be grown ("expanded") on a special layer of cells collected from the bone marrow of healthy volunteers in a laboratory. A type of sugar will also be added to the cells in the laboratory that may help the transplant to "take" faster.
NCT03096782 — Acute Myeloid Leukemia
Status: Completed
http://inclinicaltrials.com/acute-myeloid-leukemia/NCT03096782/
Safety Study of Sibling Cord Blood Cell Infusion to Children With Cerebral Palsy
This study will investigate the safety of single dose intravenous infusion of cord blood cells which were cryopreserved after the birth of a brother or sister to a child with cerebral palsy.
NCT03087110 — Cerebral Palsy
Status: Completed
http://inclinicaltrials.com/cerebral-palsy/NCT03087110/
A Multicenter, Randomized, Open-label, Two-arms Phase I/II Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy
This is a multicenter, randomized, open-label, two-arms phase I/II, clinical trial, in which 42 patients will be enrolled with the principal objective to evaluate the efficacy through changes in lesion size and, secondary, to evaluate the safety and efficacy through corneal sensibility, corneal opacity, visual acuity and complications of Neurotrophic Keratopathy (NK). Patients will be randomized 1:1 to receive experimental treatment (cord blood eye drops) or conventional treatment (artificial tears and therapeutic contact lens).
NCT03084861 — Neurotrophic Keratopathy
Status: Terminated
http://inclinicaltrials.com/neurotrophic-keratopathy/NCT03084861/