Treatment of Osteoarthritic Knee With High Tibial Osteotomy and Implantation of Allogenic Human Umbilical Cord Blood-derived Stem Cells.
The purpose of this study is to evaluate the clinical results after implantation of human umbilical cord blood-derived mesenchymal stem cells(hUCB-MSCs) and High tibia osteotomy in patients with medial compartment osteoarthritis(MCOA) as well as varus deformity of the knee joint. This study will prospectively evaluate 10 knees after hUCB-MSCs implantation and High Tibial Osteotomy(HTO) in the medial compartment osteoarthritis and varus deformity of the knee joint. Clinical outcomes will be evaluated using the International Knee Documentation committee(IKDC), Visual analogue scale(VAS), Western Ontario and McMaster Universities Arthritis Index(WOMAC), and patients satisfaction with the surgery.
NCT04234412 — Osteoarthritis, Knee
Status: Not yet recruiting
http://inclinicaltrials.com/osteoarthritis-knee/NCT04234412/
The Effect of Preoperative Anxiety on Fetal Cord Blood Tumor Necrosis Factor-Alpha and Interleukin-6 Levels in Pregnant Women
In the preoperative period, 60-80% of the patients had anxiety symptoms. This rate increases even more during pregnancy. There are a number of studies examining the role of anxiety symptoms on fetal outcome, but the mechanisms that explain the effects of maternal stress are not fully understood. The most extensively studied cytokines in neuropsychiatric disorders are TNF-α and IL-6 due to their effects on the central nervous system. TNF-α levels have been reported to be elevated in anxiety disorders. In our study, the investigators aimed to determine the relationship between preoperative anxiety levels and fetal cord blood TNF-α and IL-6 cytokine levels in pregnant women.
NCT04226573 — Preoperative Anxiety
Status: Completed
http://inclinicaltrials.com/preoperative-anxiety/NCT04226573/
Multi-center Clinical Study of Cord Blood Stem Cell Transplantation in The Treatment of Very Early-Onset Inflammatory Bowel Disease Caused by Interleukin-10 Receptor Gene Deficiency
Very early onset inflammatory bowel disease (VEO-IBD) is a special subtype of children's inflammatory bowel disease (IBD). VEO-IBD is mostly caused by single-gene defects and can be cured by allo-hematopoietic stem cell transplantation ( HSCT). Umbilical Cord Blood Transplantation (UCBT) is less reported in these patients.
NCT04170192 — Inflammatory Bowel Diseases
Status: Active, not recruiting
http://inclinicaltrials.com/inflammatory-bowel-diseases/NCT04170192/
A Phase II Open-Label Study of UM171-Expanded Cord Blood Transplantation in Patients With High and Very High Risk Acute Leukemia/Myelodysplasia
Cord blood (CB) transplants are an option for patients lacking an HLA identical donor but are hampered by low cell dose, prolonged aplasia and high transplant related mortality. UM171, a novel and potent agonist of hematopoietic stem cell self renewal could solve this major limitation, allowing for CB's important qualities as lower risk of chronic GVHD and relapse to prevail. In a previous trial (NCT02668315), the CB expansion protocol using the ECT-001-CB technology (UM171 molecule) has proven to be technically feasible and safe. UM171 expanded CB was associated with a median neutrophil recovery at day (D)+18 post transplant. Amongst 22 patients who received a single UM171 CB transplant with a median follow-up of 18 months, risk of TRM (5%) and grade 3-4 acute GVHD (10%) were low. There was no moderate-severe chronic GVHD. Thus, overall and progression free survival at 12 months were impressive at 90% and 74%, respectively. The UM171 expansion protocol allowed access to smaller, better HLA matched CBs as >80% of patients received a 6-7/8 HLA matched CB. Interestingly there were patients with high-risk hematologic malignancies and multiple comorbidities (5 patients who had already failed an allogeneic transplant and 5 patients with refractory/relapsed acute leukemia/aggressive lymphoma). Despite this high risk population, progression was 20% at 12 months. This new study seeks to test a similar strategy in a group of patients with high risk acute leukemia/myelodysplasia.
NCT04103879 — Cord Blood Transplant
Status: Active, not recruiting
http://inclinicaltrials.com/cord-blood-transplant/NCT04103879/
A Phase I/II Study of Recombinant Human Interleukin-7 to Promote T-Cell Recovery After Haploidentical and Cord Blood Stem Cell Transplantation
This phase I/II trial studies side effects and best dose of recombinant interleukin-7 in promoting immune cell recovery in patients with acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia, or myeloproliferative disease after a haploidentical or cord blood stem cell transplant. A haploidentical transplant is a transplant that uses stem cells from a donor that is partially (at least 50%) matched to the patient. Umbilical cord blood is a source of blood-forming cells that can be used for transplant, also known as a graft. However, there is a small number of blood-forming cells available in the transplant, which may delay the "take" of the graft in the recipient. Recombinant interleukin-7 may affect the "take" of the graft and the recovery of certain blood cells related to the immune system (called T-cells, natural killer cells, and B cells) in patients who have had a haploidentical or cord blood stem cell transplant.
NCT03941769 — Acute Myeloid Leukemia
Status: Completed
http://inclinicaltrials.com/acute-myeloid-leukemia/NCT03941769/
Phase I Study of Valproic Acid Expanded Cord Blood Stem Cells as an Allogeneic Donor Source for Adults With Hematological Malignancies
In this Phase I study, the study team will evaluate the safety of Valproic Acid (VPA) expanded cord blood stem cells defined by the lack of serious infusion reactions or graft failure in patients with hematological malignancies undergoing umbilical cord blood transplantation. Moreover, the study team will also evaluate time to neutrophil and platelet engraftment as well as transplant related outcomes such as graft versus host disease (GVHD), treatment related mortality (TRM), and overall survival (OS).
NCT03885947 — Myelodysplastic Syndromes
Status: Completed
http://inclinicaltrials.com/myelodysplastic-syndromes/NCT03885947/
Collect of Cord Blood From Subjects at Risk for Sickle Cell Disease, for the Purpose of Laboratory Research
The study consists in collecting umbilical cord blood cells from newborns at risk of sickle cell disease, to perform laboratory experiments aiming to characterize the cells with HbS/HbS mutation, to develop methods to prepare, to gene-modify and to preserve these cells.
NCT03876821 — Sickle Cell Disease
Status: Completed
http://inclinicaltrials.com/sickle-cell-disease/NCT03876821/
Sequential Transplantation of Umbilical Cord Blood Stem Cells and Islet Cells in Children and Adolescents With Monogenic Immunodeficiency Type 1 Diabetes Mellitus
This study evaluates the efficacy of sequential transplantation of umbilical cord blood stem cells and islet cells in children with monogenic immunodeficiency type 1 diabetes mellitus. Umbilical cord blood stem cell transplantation will be performed first. Children with stable immune reconstruction will than receive islet cell transplantation.
NCT03835312 — Diabetes Mellitus, Type 1
Status: Recruiting
http://inclinicaltrials.com/diabetes-mellitus-type-1/NCT03835312/
Phase IIb Study of Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Stage II Surgical Repair of Right Ventricular Dependent Variants of Hypoplastic Left Heart Syndrome (AutoCell-S2)
Researchers want to better understand what happens to the heart when the stem cells are injected directly into the muscle of the right side of the heart during the Stage II palliative surgery for single ventricle patients with hypoplastic left heart syndrome (HLHS) or HLHS variant. Researchers want to see if there are changes in the heart's structure/function following this stem cell-based therapy and compared to children that have not had cell-based therapy.
NCT03779711 — Hypoplastic Left Heart Syndrome
Status: Active, not recruiting
http://inclinicaltrials.com/hypoplastic-left-heart-syndrome/NCT03779711/
The Effect of Maternal Long Term High Flow Oxygen Administration During Labor on Umbilical Cord Blood Gases
Supplementary oxygen is routinely administered to patients, even those with adequate oxygen saturations, in the belief that it increases oxygen delivery. However, oxygen delivery depends not just on arterial oxygen content but also on perfusion. Maternal oxygen administration has been used in an attempt to lessen fetal distress by increasing the available oxygen from the mother. However, the effect of supplemental maternal oxygen therapy on fetal acid base status has been debated for more than seven decades. The investigators found the use of 2 L/min maternal oxygen during the second stage of labor did not adversely affect either the umbilical artery pH value or the fetal heart rate (FHR) pattern distribution.
NCT03764696 — Fetal Distress
Status: Completed
http://inclinicaltrials.com/fetal-distress/NCT03764696/