To evaluate if HLA-mismatched, unrelated-donor umbilical cord blood stem and progenitor cell units (UCBU) offered a clinically acceptable alternative to matched unrelated-donor allogeneic bone marrow for transplantation with 180-day disease free survival as the endpoint. HLA typing was performed using DNA-base high resolution methods to determine HLA alleles. Patients with "true" HLA 3/6 and 4/6 matches were evaluated. In addition, a separate study in adults addressed the problem of limited cell dose and engraftment failure. The study was not planned as a randomized comparative clinical trial. Instead, it is a phase II/III efficacy study.
NCT00000603 — Leukemia
Status: Completed
http://inclinicaltrials.com/leukemia/NCT00000603/
A Phase I/II Study of Allogeneic Umbilical Cord Blood and Umbilical Cord Tissue-Derived Mesenchymal Stromal Cell Infusions in Children With Cerebral Palsy
The main purpose of this study is to estimate change in motor function 12 months after treatment with a single dose of allogeneic umbilical cord blood (AlloCB) or repeated doses of umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) in children with cerebral palsy. In addition, this study will contribute much needed data to the clinical trials community on the natural history of the motor function in CP over short-term (less than 1 year) time periods relevant to the conduct of clinical trials and assess the safety of AlloCB and hCT-MSC infusion in children with cerebral palsy.
NCT03473301 — Cerebral Palsy
Status: Completed
http://inclinicaltrials.com/cerebral-palsy/NCT03473301/
Evaluation of the 'SensPoint' Lactate Meter Validation of a Hand-Held Lactate Measuring System 'SensPoint' in the Estimation of Foetal Scalp Blood and Umbilical Cord Blood Lactate
A cardiotocograph (CTG) can be used in labour to assess the heartbeat and well-being of a baby. An abnormal CTG may be a sign that a baby has low oxygen levels (hypoxia) and is becoming distressed. In this situation a blood test can be taken from the scalp of the baby. A high lactate level in the blood indicates that urgent delivery is required to prevent long-term harm to the newborn. SensPoint is a new medical device that measures lactate. It has several potential benefits over the current method of measuring lactate in that it is a portable hand-held device (allowing for use in the delivery room), requires a much smaller volume of blood and produces results more quickly than the current method of measuring lactate. Before a new device is adopted into clinical practice, it is important that it is first confirmed that it is accurate and reliable for its intended use. This study will evaluate the ability of the SensPoint device to accurately and reliably detect lactate in fetal and umbilical cord blood by comparing its performance to the reference device currently in use.
NCT02522273 — Measurement of Fetal Blood Lactate
Status: Withdrawn
http://inclinicaltrials.com/measurement-of-fetal-blood-lactate/NCT02522273/
Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn, Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells, to Expedite Engraftment and Improve Transplant Outcome
Background: Severe aplastic anemia (SAA) and myelodysplastic syndrome (MDS) are bone marrow diseases. People with these diseases usually need a bone marrow transplant. Researchers are testing ways to make stem cell transplant safer and more effective. Objective: To test if treating people with SAA or MDS with a co-infusion of blood stem cells from a family member and cord blood stem cells from an unrelated donor is safe and effective. Eligibility: Recipients ages 4-60 with SAA or MDS Donors ages 4-75 Design: Recipients will be screened with: - Blood, lung, and heart tests - Bone marrow biopsy - CT scan Recipients will have an IV line placed into a vein in the neck. Starting 11 days before the transplant they will have several chemotherapy infusions and 1 30-minute radiation dose. Recipients will get the donor cells through the IV line. They will stay in the hospital 3-4 weeks. After discharge, they will have visits: - First 3-4 months: 1-2 times weekly - Then every 6 months for 5 years<TAB> Donors will be screened with: - Physical exam - Medical history - Blood tests Donors veins will be checked for suitability for stem cell collection. They may need an IV line to be placed in a thigh vein. Donors will get filgrastim injections daily for 5-7 days. On the last day, they will have apheresis: Blood drawn from one arm or leg runs through a machine and into the other arm or leg. This may be repeated 2 days or 2-4 weeks later.
NCT03173937 — Myelodysplastic Syndrome (MDS)
Status: Recruiting
http://inclinicaltrials.com/myelodysplastic-syndrome-mds/NCT03173937/
A Phase 2 Controlled Trial of a Single ProHema®-CB Unit (Ex Vivo Modulated Human Cord Blood) As Part of a Double Umbilical Cord Blood Transplant Following Myeloablative or Reduced Intensity Conditioning For Patients Age 15-65 Years With Hematologic Malignancies.
This study is an open-label randomized, prospectively and historically controlled trial of the safety and efficacy of a single ProHema-CB unit used as part of a double CB transplant following myeloablative or reduced intensity conditioning for subjects age 15-65 years with hematologic malignancies. A maximum of 60 eligible subjects will be enrolled and treated in the trial at approximately 10 centers within the U.S.
NCT01627314 — Hematologic Malignancies
Status: Terminated
http://inclinicaltrials.com/hematologic-malignancies/NCT01627314/
A Novel Post-transplant Regimen of PT/FLU+CY for Selectively Promoting Unrelated Cord Blood Engraftment in Haploidentical-Cord Transplantation in Childhood Leukemia: a Single-arm, Multi-center Trial
To determine if the novel regimen of PT/FLU+CY promotes cord blood engraftment in children's leukemia HSCT cohort
NCT06155188 — Leukemia
Status: Recruiting
http://inclinicaltrials.com/leukemia/NCT06155188/
A Multicenter Collaborative Clinical Study of Umbilical Cord Blood Combined With Umbilical Cord Derived Mesenchymal Stem Cells in the Treatment of Bone Marrow Failure Disorders
The multicenter collaborative clinical study conducted a systematic clinical observation in the treatment of bone marrow failure diseases via UCB&UC-MSCs , in order to observe its clinical efficacy and safety.
NCT05794425 — Bone Marrow Failure Disorders
Status: Recruiting
http://inclinicaltrials.com/bone-marrow-failure-disorders/NCT05794425/
Safety, Feasibility and Efficacy of Red Blood Cells From Umbilical Cord Blood for Transfusion of Extremely Preterm Infants: Clinical Phase
This study has been designed to demonstrate that red blood cell from umbilical cord blood (UCB-RBC) is a safe and available product for extremely preterm infants (EPI) transfusion and that transfusion of UCB-RBC is non-less effective than RBC from adult donor for the treatment of anemia of prematurity in this group of patients.
NCT05612919 — Erythrocyte Transfusion
Status: Recruiting
http://inclinicaltrials.com/erythrocyte-transfusion/NCT05612919/
The Correlation Between LIF Levels in Cord Blood to Maternal Blood in Women Treated With Mg During Labor
During embryonic development, there are several cytokines such as: LIF (Leukemia inhibitory factor), ciliary neurotrophic factor (CNTF), epidermal growth factor family (EGF), neuregulin 1 (NRG1) and transforming growth factor β (TGFβ) that were found are associated with neurogenesis and differentiation of brain cells. LIF is a cytokine that is essential for the development of the central nervous system, and has recently been shown in rats that maternal LIF stimulates placental ACTH (adrenocorticotropic hormone) that in turn promotes secretion of fetal LIF from nRBC (nucleated red blood cell ), which in turn promotes brain development of the fetus In other studies on rats a theory was proposed that LPS (lipopolysaccharide) and infection during pregnancy influence the normal development of the brain and may cause brain damage by altering placental ACTH thank in turn alters LIF secretion in the embryo which could be the cause of brain damage. Our hypothesis is that by treating the mother with Magnesium Sulphate we can protect the embryo's brain in one of two ways: 1. Altering Placental ACTH 2. Altering the number of receptors for LIF in the brain Women who are at risk for preterm labor prior to 32 weeks of gestation are treated with Magnesium Sulphate for neuroprotection, randomized controlled studies showed that if these women are treated in the 24 hours prior to labor with magnesium sulphate the risk for cerebral palsy and other severe motor problems are decreased. The mechanism for this decrease is unknown and that is the purpose of our study. The purpose of our research is to examine maternal LIF levels prior to birth and Maternal and cord levels after delivery and to see if levels are different if the mother was treated with Magnesium Sulphate. We will also check the placental ACTH level
NCT02507817 — LIF LEVELS IN CORD BLOOD AND MATERNAL BLOOD DURING LABOR
Status: Not yet recruiting
http://inclinicaltrials.com/lif-levels-in-cord-blood-and-maternal-blood-during-labor/NCT02507817/
Neuromodulation of Blood Pressure Using Transcutaneous Spinal Stimulation in Individuals With an Acute Spinal Cord Injury - A Safety, Feasibility and Efficacy Study
The goal of this clinical trial is to evaluate the effect of transcutaneous spinal cord stimulation on blood pressure in individuals with an acute spinal cord injury (within 30 days of injury). Blood pressure instability, specifically orthostatic hypotension (a drop in blood pressure when moving lying flat on your back to an upright position), appears early after the injury and often significantly interferes with participation in the critical rehabilitation time period. The main questions it aims to answer are: 1. Can optimal spinal stimulation increase blood pressure and resolve orthostatic symptoms (such as dizziness and nausea) when individuals undergo an orthostatic provocation (a sit-up test)? Optimal stimulation and sham stimulation (which is similar to a placebo treatment) will be compared. 2. What are the various spinal sites and stimulation parameters that can be used to increase and stabilize blood pressure to the normal range of 110-120 mmHg? Participants will undergo orthostatic tests (lying on a bed that starts out flat and then moved into an upright seated position by raising the head of bed by 90° and dropping the base of the bed by 90° from the knee) with optimal and sham stimulation, and their blood pressure measurements will be evaluated and compared.
NCT05731986 — Cardiovascular Diseases
Status: Recruiting
http://inclinicaltrials.com/cardiovascular-diseases/NCT05731986/