THERAPY DOSSIER · th-2e3114efdf11

Small intestine submucosa-derived decellularised extracellular matrix (SIS-ECM)

Biologic

Evidence & regulatory context

Mechanism: Not recorded
Target: Not recorded
Injury models: Fracture
Reported indication: Not recorded
First approval: Not recorded
Development stage: Not recorded
ChEMBL record: Not recorded
ChEMBL max phase: Not recorded
Synonyms: Not recorded
Note: Not recorded

Clinical trials 4

0 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT02994589 ↗PHASE4withdrawn

A Comparison of OASIS Wound Matrix (porcine SIS) With Approved Dressings for Split Thickness Skin Graft Donor Sites

Skin Graft Complications

Enrolment: 0 · Results not recorded

NCT02887768 ↗EARLY_PHASE1completed

Cardiac Infarct Repair Using CorMatrix-ECM (SIS-derived): Clinical Feasibility Study

Acute Coronary Syndrome · Heart Failure

Enrolment: 8 · Results not recorded

NCT05789914 ↗NAunknown

Extracellular Matrix Scaffold of Small Intestinal Submucosa for Guided Tissue Regeneration (flap surgery + bone graft)

Guided Tissue Regeneration · Extracellular Matrix Scaffold of Small Intestinal Submucosa

Enrolment: 20 · Results not recorded

NCT07698171 ↗NAcompleted

Myringoplasty Using Porcine Small Intestinal Submucosa (Biodesign) Versus Autologous Grafts for Tympanic Membrane Perforation

Tympanic Membrane Perforation · Tympanoplasty · Myringoplasty

Enrolment: 60 · Results not recorded

Preclinical evidence 1

1 studies reported at therapy level; 1 evidence entries itemised.

PMID 27533905 ↗2016Reported harm

Decellularized extracellular matrix repair of volumetric muscle loss injury impairs adjacent bone healing in a rat model of complex musculoskeletal trauma.

RatFractureOpen tibiaLewismalen = n=10 total, n=5 per grouplocal surgical implantation into the volumetric muscle loss defectconcomitant with injury creation

Model: 3 mm segmental bone defect created concomitantly with a 6 mm full-thickness volumetric muscle loss injury to the tibialis anterior muscle, complex musculoskeletal trauma model

SIS-ECM repair of the volumetric muscle loss injury impaired adjacent open fracture healing, with significantly lower bone volume to total volume (27% lower at 6 weeks) versus no repair, and failed to improve tibialis anterior muscle strength, which showed similar deficits in both groups.

Extraction: extract · Subtype source: review · Supplied extraction confidence: 0.7. Machine-extracted fields require source verification.

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