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A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extreme1
OHB Neonatology Ltd.
Bronchopulmonary Dysplasia
Chronic Lung Disease of Prematurity
Intraventricular Hemorrhage
Retinopathy of Prematurity (ROP)
The purpose of this study is to determine if an investigational drug can prevent
Bronchopulmonary Dysplasia, reducing the burden of chronic lung disease in extremely
premature infants, as compared to extremely premature infants receiving standard neonatal
care alone. expand
The purpose of this study is to determine if an investigational drug can prevent Bronchopulmonary Dysplasia, reducing the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants receiving standard neonatal care alone. Type: Interventional Start Date: May 2019 |
A Study of Auxora in Patients With AKI and Injurious Lung "Crosstalk"
CalciMedica, Inc.
Acute Kidney Injury
Approximately 150 patients with acute kidney injury (AKI) associated with acute hypoxemic
respiratory failure (AHRF) will be randomized at up to 40 sites. Patients will be
randomly assigned to either Auxora or matching placebo. Study drug infusions will occur
every 24 hours for five consecutive day1 expand
Approximately 150 patients with acute kidney injury (AKI) associated with acute hypoxemic respiratory failure (AHRF) will be randomized at up to 40 sites. Patients will be randomly assigned to either Auxora or matching placebo. Study drug infusions will occur every 24 hours for five consecutive days for a total of five infusions. Type: Interventional Start Date: Jul 2024 |
Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS)
Direct Biologics, LLC
Acute Respiratory Distress Syndrome
ARDS
To evaluate the safety and efficacy of intravenous (IV) administration of bone marrow
mesenchymal stem cell derived extracellular vesicles (EVs), ExoFlo, versus placebo for
the treatment of hospitalized patients with moderate-to-severe Acute Respiratory Distress
Syndrome (ARDS). expand
To evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles (EVs), ExoFlo, versus placebo for the treatment of hospitalized patients with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS). Type: Interventional Start Date: Jul 2022 |
High Dose Ascorbic Acid (HDAA) in Patients With Plasma Cell Disorders
University of Arkansas
Plasma Cell Disorder
The purpose of this research is to evaluate whether HDAA in combination with a single
dose of 100 mg/m2 IV melphalan followed by autologous stem cell transplantation (ASCT) is
safe and effective for subjects with relapsed refractory multiple myeloma. The proposed
melphalan dose is 50% of the curren1 expand
The purpose of this research is to evaluate whether HDAA in combination with a single dose of 100 mg/m2 IV melphalan followed by autologous stem cell transplantation (ASCT) is safe and effective for subjects with relapsed refractory multiple myeloma. The proposed melphalan dose is 50% of the current standard myeloablative dose (200 mg/m2). Based on our preclinical data, the investigator hypothesize that the combination of reduced dose melphalan with IV HDAA will have high efficacy and tolerability Primary Objective To determine tumor response using International Myeloma Working Group (IMWG) criteria (see Appendix B). Secondary Objectives Objectives: 1. Determine the safety and tolerability of HDAA in combination with reduced dose melphalan conditioning and autologous stem cell transplantation (ASCT) in relapsed refractory multiple myeloma subjects. 2. Determine the rate of Minimal Residual Disease (MRD) negativity at time point of response assessment using 8 color flow cytometry on BM sample. Functional imaging, such as positron emission tomography (PET) scan and magnetic resonance imaging (MRI), will also be performed to assess the disease status. 3. Categorize and quantify adverse events compared to historical control. 4. Determine quality of life parameters using standardized health-related quality of life measures 5. Determine oxidative stress parameters in plasma during treatment. Type: Interventional Start Date: Jul 2024 |
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