We here report the results of a Phase I/IIa open-label four dose-escalation clinical study assessing the safety, tolerability, and possible therapeutic efficacy of a single intramuscular administration of DVC1-0101, a new gene transfer vector based on a nontransmissible recombinant Sendai virus (...
To assess the safety and feasibility of MSCs in preterm infants with severe IVH, we performed a phase I dose‐escalation clinical trial. The first three patients received a low dose of MSCs (5 × 106 cells/kg), and the next six received a high dose (1 × 107 cells/kg). We assessed...
All participants remained on effective anti-retroviral therapy (viral load (VL) <50 copies per milliliter) throughout this phase 1, dose-escalation clinical trial (NCT03374202). AAV8-VRC07 was given at doses of 5 × 1010, 5 × 1011 and 2.5 × 1012 vector genomes per ...
A phase 1, dose-escalation, single centre clinical trial was conducted in Madrid, Spain, including 9 patients. We describe the safety and feasibility of the infusion. No serious adverse effects were reported. Inflammatory parameters were stabilised post-infusion. All participants’ clinical status ...
A single arm, multi-center, phase II, dose escalation prospective clinical trial employing the i3 + 3 design is being conducted to examine the safety of a radiation dose-escalation strategy aimed at inducing transmural scar formation. The ultimate objective of this trial is to decrease the ...
This prospective phase Ib dose-escalation clinical trial evaluated the tolerability of intravenous administration of radiosensitizing AGuIX nanoparticles plus WBRT for patients with multiple brain metastases (ClinicalTrials.gov identifier: NCT02820454). This investigator-initiated trial was sponsored by the Gr...
[medical learning] dose-escalation study A study that determines the best dose of a new drug or treatment. In a dose-escalation study, the dose of the test drug is increased a little at a time in ...
[31] reported a dose escalation trial with simultaneously given doxorubicin and described high rates of acute gastrointestinal grade III-IV toxicity (18%) and hematological toxicity (27%) in patients treated at the 50.4 Gy dose level, although at least parts of the side effects might be ...
The influence of this selection and dose escalation on freedom from biochemical progression (bNED) was analyzed. Results: The median follow-up of the whole group was 30 months, the median pre-SRT PSA was 0.28 ng/ml. Of the patients, 27% (82/301) developed biochemical progression, 31% ...
1. 剂量递增 中心第一期剂量递增(dose-escalation) www1.cde.org.tw|基于2个网页 2. 剂量渐增试验 ...低的起始剂量(starting dose)试起,作剂量渐增试验(dose-escalation);也可以是很小的样本数(sample size),例如先 … itissandra.pixnet.net|基于2个网页 ...