RGTA® (ReGeneraTing Agent) are synthetic polysaccharides mimicking extra-cellular matrix scaffold elements and protective agents called Heparan Sulphates (HSPGs). OTR4132-MD is provided as a sterile injectable medical device. OTR4132-MD is indicated in anterior circulation acute ischemic stroke (AIS) patients re-vascularized (TICI score 2b - 3) by endovascular thrombectomy combined or not with thrombolysis.
The promising results of OTR4132-MD in the treatment of acute ischemic stroke in animal studies and the excellent results of biocompatibility tests reported in the Investigator's Brochure allowed to design a clinical investigation in humans named MATRISS. As this is a First-In-Man (FIM) study assessing OTR4132-MD, it is designed as a single ascending dose (SAD) to evaluate the safety, tolerability of a single intra-arterial injection of OTR4132-MD in AIS patients treated with thrombectomy combined or not with thrombolysis. The FIM will include up to 19 patients in up to six dose groups. Each group will comprise 3 subjects. This FIM study will also monitor a dose response relationship in humans: lesion volume change throughout the study period. Patients will be given a single intra-arterial injection of OTR4132-MD with a predefined dose of OTR4132. In the first dose group, the OTR4132 dose is 0.20 mg. The results of this study will serve as a groundwork for the design of a pivotal study in the intended patient population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
According to Regulation (EU) 2017/745(MDR), OTR4132-MD is an implantable medical device, for short term use which is specifically intended for use in direct contact with systemic circulation system. OTR4132-MD is by definition intended to come into contact with the patient when being injected. It is administered through intra-arterial injection, in an one-shot dose and the majority of the product is eliminated within 24 hours.
CHU Grenoble Alpes
Grenoble, Auvergne-Rhône-Alpes, France
CHU Nancy
Nancy, Grand Est, France
CHU Bordeaux Pellegrin
Bordeaux, Nouvelle-Aquitaine, France
Rate of severe adverse events device related and dose limiting
Severe adverse events
Time frame: 7 Days
Survival rates
survival rates
Time frame: 24 hours, 7 Days, 30 Days, 90 Days
All cause death
All cause death
Time frame: 24 hours, 7 Days, 30 Days, 90 Days
Stroke related death
Stroke related death
Time frame: 24 hours, 7 Days, 30 Days, 90 Days
Rate of device related adverse events (AEs) and serious adverse events (SAEs)
rate of device related adverse events
Time frame: 24 hours, 7 Days, 30 Days, 90 Days
Rate of adverse events (AEs) and serious adverse events (SAEs) procedure related
Rate of AEs and SAEs propcedure related
Time frame: 24 hours, 7 Days, 30 Days, 90 Days
Symptomatic intracranial haemorrhage
Intracranial haemorrhage
Time frame: 24 hours, 7 Days, 30 Days, 90 Days
Brain oedema on 24-hour follow-up imaging
brain oedema
Time frame: 24 hours
New ischaemic lesions
Ischaemic lesions in new territories on 24-hours follow-up imaging
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 24 hours