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Clinical Trial Summary

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 combined thrombolysis and endovascular thrombectomy within 6 hours of symptoms onset.


Clinical Trial Description

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 combined thrombolysis and thrombectomy. The FIM will include up to 18 patients in up to five 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 Design


Related Conditions & MeSH terms


NCT number NCT04083001
Study type Interventional
Source Organ, Tissue, Regeneration, Repair and Replacement
Contact
Status Active, not recruiting
Phase N/A
Start date March 3, 2022
Completion date April 2024

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