The Register · A provider

PolTREG S.A.

Gdańsk · Poland

Specialties

cell therapy development regulatory T cell therapy type 1 diabetes treatment T-regulatory cell therapy Type 1 Diabetes Multiple sclerosis stem cell manufacturing

Reports that name this provider

Stem Cell Legality in Poland: GMP certification from GIF in March 2024; initiated Phase II Treg cell therapy trial for pre-symptomatic type 1 diabetes in October 2024; positive EMA Pediatric Committee opinion issued in May 2025; GMP-certified manufacturing facility; active Phase II clinical trials with URPL oversight; CAR-Treg first-in-human trials in multiple sclerosis and amyotrophic lateral sclerosis anticipated.
Stem Cell Therapy Quality in Poland: CGMP certification from Chief Pharmaceutical Inspectorate March 2024; 2,100 m² manufacturing facility with 15 production lines capable of distributing live cell products across Europe within 24 hours; conducting EMA-approved Phase 2 clinical trials; 17+ years of patient experience; published long-term safety data extending to 12 years

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