A Randomised, Double Blind, Multi-center, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of NT100 in Pregnant Women With a History of Unexplained Recurrent Pregnancy Loss (RPL)

This is a randomised, double blind, multi-center, placebo-controlled study of subcutaneous NT100 in pregnant women with a history of unexplained recurrent pregnancy loss. Approximately 150 participants will be randomised to receive subcutaneous NT100 or placebo.

Start Date01 Jun 2014

Sponsor / Collaborator

Nora Therapeutics, Inc.

EUCTR2014-000084-40-GB / Not yet recruitingPhase 2

A randomized, double blind, multi-center, placebo-controlled study to evaluate the efficacy, safety, and tolerability of NT100 in pregnant women with a history of unexplained recurrent pregnancy loss (RPL).

Start Date07 Apr 2014

Sponsor / Collaborator

Nora Therapeutics, Inc.

NCT01978561 / CompletedPhase 2

Pregnancy, Delivery, And Neonatal Outcomes In Subjects With Ongoing Pregnancies Established During Study NT-03 (Thrive-IVF Follow-Up)

The purpose of this study is to evaluate pregnancy, delivery, and neonatal outcomes in subjects who maintain ongoing clinical pregnancies through Week 10 of gestation in NT-03.

Start Date01 Oct 2013

Sponsor / Collaborator

Nora Therapeutics, Inc.

100 Clinical Results associated with NT-100

100 Translational Medicine associated with NT-100

100 Patents (Medical) associated with NT-100

Literatures (Medical) associated with NT-100

18 Mar 2024·Ying yong sheng tai xue bao = The journal of applied ecology

Effects of long-term no-tillage and different stover mulching amounts on soil carbon and nitrogen contents and enzyme activities of carbon and nitrogen cycle in Mollisols.

Article

Author: Xu, Xin ; Xie, Hong-Tu ; Yang, Ya-Li ; Bao, Xue-Lian ; Yu, Yang ; Zheng, Tian-Tian ; Lyu, Fu-Ze ; Zhang, Chang-Ren

To understand the effects of different stover mulching amounts in no-tillage on soil carbon and nitrogen contents and enzyme activities, finding a stover mulching amount which can meet the requirement of soil carbon and nitrogen accumulation while maximizing economic benefits, we conducted a long-term conservation tillage field experiment since 2007 in Mollisols area of Northeast China. We analyzed soil carbon and nitrogen contents, enzyme activities and economic benefits under conventional tillage (Control, CT), no-tillage without stover mulching (NT₀), no-tillage with 33% stover mulching (NT₃₃), no-tillage with 67% stover mulching (NT₆₇), and no-tillage with 100% stover mulching (NT₁₀₀) before planting in May 2020. The results showed that compared with CT, NT₀ did not affect soil organic carbon (SOC) and total nitrogen (TN) contents, but increased soil organic carbon recalcitrance and decreased the availability of dissolved organic nitrogen (DON) and ammonium nitrogen. Compared with NT₀, no-tillage with stover mulching significantly increased SOC contents in 0-10 cm layer and increased with the amounts of stover. In addition, NT₆₇ and NT₁₀₀ significantly increased SOC stocks, facilitating the accumulation of soil organic matter. The effects of different stover mulching amounts on soil nitrogen content in 0-10 cm layer were different. Specifically, NT₃₃ increased DON content and DON/TN, NT₆₇ increased DON content, while NT₁₀₀ increased TN content. Compared with CT, NT₀ decreased peroxidase (POD) activity in 0-10 cm layer. Compared with NT₀, NT₃₃ increased β-glucosidase (βG), cellobiase (CB), 1,4-β-N-acetylglucosaminidase (NAG), polyphenol oxidase (PPO) and POD activities, while NT₆₇ only increased CB, NAG and POD activities in 0-10 cm soil layer, both alleviated microbial nutrient limitation. NT₁₀₀ increased PPO activity in 10-20 cm layer. NT₃₃ increased carbon conversion efficiency of stover compared with NT₁₀₀, and had the highest economic benefit. In all, no-tillage with 33% stover mulching was the optimal strategy, which could promote nutrient circulation, boost stover utilization efficiency, improve the quality of Mollisols, and maximize guaranteed income.

01 Mar 2023·Biomedical Materials

TiO₂ nanotubes induce early mitochondrial fission in BMMSCs and promote osseointegration

Article

Author: Zhang, Zhouyang ; Xin, He ; Liu, Fuwei ; Hou, Yan ; Kong, Liang ; Ning, Xiaona ; Lv, Qian-Xin ; Chen, Yicheng ; Wang, Le ; Jia, Xuelian

AbstractNanotopography can promote osseointegration, but how bone marrow mesenchymal stem cells (BMMSCs) respond to this physical stimulus is unclear. Here, we found that early exposure of BMMSCs to nanotopography (6 h) caused mitochondrial fission rather than fusion, which was necessary for osseointegration. We analyzed the changes in mitochondrial morphology and function of BMMSCs located on the surfaces of NT100 (100 nm nanotubes) and ST (smooth) by super-resolution microscopy and other techniques. Then, we found that both ST and NT100 caused a significant increase in mitochondrial fission early on, but NT100 caused mitochondrial fission much earlier than those on ST. In addition, the mitochondrial functional statuses were good at the 6 h time point, this is at odds with the conventional wisdom that fusion is good. This fission phenomenon adequately protected mitochondrial membrane potential (MMP) and respiration and reduced reactive oxygen species. Interestingly, the MMP and oxygen consumption rate of BMMSCs were reduced when mitochondrial fission was inhibited by Mdivi-1(Inhibition of dynamin-related protein 1 fission) in the early stage. In addition, the effect on osseointegration was significantly worse, and this effect did not improve with time. Taken together, the findings indicate that early mitochondrial fission plays an important role in nanotopography-mediated promotion of osseointegration, which is of great significance to the surface structure design of biomaterials.

01 Jan 2020·Birth Defects ResearchQ4 · MEDICINE

Defect evaluation by infant photographs in a multicenter pharmaceutical clinical trial

Q4 · MEDICINE

Article

Author: Kwon, Paul ; Joing, Mark ; Scheuerle, Angela E.

AbstractObjectThe NT‐04 clinical trial of investigational medication NT100 had a limited, though geographically diverse, study population. To enhance potential birth defect identification, photographic dysmorphology exam of infants was performed along with review of prenatal and postnatal medical records.MethodsStandardized photographic views were developed: full body (prone and supine), face, both profiles, dorsal and ventral hands and feet, genitalia, and birthmarks/skin lesions. Professional photographers were identified and trained. Photos were taken in the first month of life at the subject's home and uploaded to a secure electronic online photo viewer. The evaluating geneticist accessed the photos electronically and submitted an evaluation.ResultsForty subjects had 39 evaluable outcomes (55 babies). Twelve photographers were recruited, 10 of whom worked with multiple subjects. Photographic dysmorphology evaluation was done on 38 pregnancy outcomes. Only one baby had missing photos due to an apparent protocol error. Four babies were photographed with diaper on.ConclusionsThe standardized photographs worked well. Advantages include: a single clinician evaluating all infants, the photographs could be reviewed repeatedly as needed, and minor malformations were more uniformly identified. Difficulties were: identifying local photographers and supplying training and training materials. There was no protocol for retaking or obtaining new photos and the study consent form did not include permission to publish the photographs. This was a successful pilot study of infant photographic assessment to detect congenital anomalies in a clinical trial.

100 Deals associated with NT-100

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Infertility, Female	Phase 3	GB	Nora Therapeutics, Inc.	-
Abortion	Preclinical	GB	Nora Therapeutics, Inc.	01 Jun 2014
Abortion, Habitual	Preclinical	GB	Nora Therapeutics, Inc.	01 Jun 2014
Ventricular Fibrillation, Paroxysmal Familial, 1	Preclinical	US	Nora Therapeutics, Inc.	01 May 2013

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