NCT04083001: MATRISS

An Open, Study to Assess the Safety of RGTA® (OTR4132) in Patients With Acute Ischemic Stroke (AIS)

Completed NA Last updated 2 August 2024

What this trial tests

NA trial testing OTR4132MD in Stroke, Acute in 19 participants. Completed in 19 June 2024.

Timeline

3 March 2022

Primary endpoint
19 June 2024

19 June 2024

Quick facts

Lead sponsor	Organ, Tissue, Regeneration, Repair and Replacement
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	3 March 2022
Primary completion	19 June 2024
Estimated completion	19 June 2024
Sites	3 locations across France

Drugs / interventions tested

• OTR4132MD

Conditions studied

• Stroke, Acute — all drugs for Stroke, Acute →

Sponsor

Organ, Tissue, Regeneration, Repair and Replacement

Who can join

Adults 45 to 80, any sex, with Stroke, Acute. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mimicking Extracellular Matrix via Engineered Nanostructured Biomaterials for Neural Repair.
   Raspa A, Gelain F. · · 2021 · cited 14× · PMID 33176654 · DOI 10.2174/1570159x18666201111111102
2. Insights into Advances and Applications of Biomaterials for Nerve Tissue Injuries and Neurodegenerative Disorders.
   Pai V, Singh BN, Singh AK. · · 2024 · cited 13× · PMID 39348168 · DOI 10.1002/mabi.202400150
3. Perspective insights into hydrogels and nanomaterials for ischemic stroke.
   Yu Q, Jian Z, Yang D, Zhu T. · · 2022 · cited 8× · PMID 36761147 · DOI 10.3389/fncel.2022.1058753
4. Restoring brain barriers: an innovative approach for treating neurological disorders.
   Lemarchant S, Engelhardt B, Cicchetti F, Bix GJ, et al · · 2025 · cited 5× · PMID 40640916 · DOI 10.1186/s12987-025-00688-z
5. A review: Carrier-based hydrogels containing bioactive molecules and stem cells for ischemic stroke therapy.
   Yin W, Jiang Y, Ma G, Mbituyimana B, et al · · 2025 · cited 5× · PMID 40124600 · DOI 10.1016/j.bioactmat.2025.01.014
6. Hydrogel-based biomaterials for brain regeneration after stroke: Gap to clinical translation.
   Li H, Gu T, Xu J, Gan L, et al · · 2025 · cited 1× · PMID 40641992 · DOI 10.12336/bmt.24.00020
7. Biomaterials-driven stem cell therapy for tissue repair and functional rehabilitation after ischemic stroke.
   Wang M, Ran Y, Liang J, Li F, et al · · 2025 · PMID 41244328 · DOI 10.1002/btm2.70060
8. Intra-arterial Injection of OTR4132, a Novel Neuroprotector in Acute Ischemic Stroke: The MaTRISS Trial.
   Barreau X, Anxionnat R, Heck O, Sibon I, et al · · 2025 · PMID 41037228 · DOI 10.1007/s40261-025-01487-y