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The Purpose of the Study is to Evaluate the Safety and Performance of ENCRT-103-hPI in Patients With Type I Diabetes. ENCRT-103-hPI is an Implantable Product Shielding Primary Islets From the Immune System.

29. juni 2026 opdateret af: Encellin

Evaluation of ENCRT-103-hPI, an Immune-protected Combination Product Containing Primary Human Islets in Adults With Type 1 Diabetes, With and Without Standard-of-care Portal Vein Islet Infusion.

This study will evaluate the safety and performance of ENCRT-103-hPI, which is a cargo of primary islets inside Encellin's ENC-103-CED. The 103 offers a soft pillow-like encasing to contain and protect the cells from the immune system. The product is implanted in the upper arm or abdomen and is approximately the size of a quarter. Eligibility is open to both patients on a standard of care islet infusion wait list, as well as those who are not. Participation in this trial does not preclude future Encellin trial participation. The study duration is 4.5months and requires keeping the implant for 4 months, as well as adhering to a standard of care schedule of follow ups during the implant period.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is a dual-arm, three-centre, non-randomized, FIH trial that will evaluate the safety of the ENCRT-103-hPI in patients with T1D. Study subjects may be receiving standard of care islet infusion (cohort A), or not (cohort B). Cohort B will receive a special access drug regimen compared to cohort A's standard of care immune management.

Both cohorts will experience equivalent processes: donor matching, comparable ENCRT-103-hPI dosages, implant into the upper arm or abdomen, explant at 4 mo and post surgical followup.

The primary objective is to evaluate the safety, tolerability, and local tissue response of fully immune-protected ENCRT devices containing primary human islets in adults with Type 1 Diabetes. Included in assessments are vascular integration and immune cell exclusion.

The secondary objectives are to evaluate of the activity, function, and survival of the donor islets from the retrieved ENCRT-103-hPI.

The exploratory objectives include measures of circulating and stimulated C-peptide, HbA1c, insulin use doses, and when available, CGM trends.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

10

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Vancouver General Hospital
        • Ledende efterforsker:
          • Michael Bleszynski, MD
    • Ontario
      • Toronto, Ontario, Canada
        • UHN
        • Ledende efterforsker:
          • Trevor Reichman, MD
        • Kontakt:
    • Quebec
      • Montreal, Quebec, Canada
        • McGill University Health Centre
        • Kontakt:
        • Ledende efterforsker:
          • Rohan Kumar, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B).

Exclusion Criteria:

  • - follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Enhedens gennemførlighed
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cohort A: ENCRT-103-hPI with standard of care
Patients receive standard of care islet infusion and the intervention of an ENCRT implant on the same day. Cohort A also receives standard of care drug regimen for immune management.
Enhed: ENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo.

The ENC-103-CED is a unique device on the landscape. It is a soft, device made of non-fibrosis inducing material and design features. ENCRT-103-hPI that will be implanted consists of this device loaded with primary islets.

Both cohorts A and B will receive the intervention of an ENCRT-103-hPI implant.

Andre navne:
  • ENCRT
  • ENCRT-103
  • ENCRT-103-hPI
  • ENC-103
  • ENC-103-CED
Eksperimentel: Cohort B: ENCRT-103-hPI only
Patients receive only an ENCRT implant (the intervention) and a special access drug regimen for immune management.
Enhed: ENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo.

The ENC-103-CED is a unique device on the landscape. It is a soft, device made of non-fibrosis inducing material and design features. ENCRT-103-hPI that will be implanted consists of this device loaded with primary islets.

Both cohorts A and B will receive the intervention of an ENCRT-103-hPI implant.

Andre navne:
  • ENCRT
  • ENCRT-103
  • ENCRT-103-hPI
  • ENC-103
  • ENC-103-CED

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of device-related adverse events (AEs)
Tidsramme: 4.5-5 months
The primary objective is to evaluate the safety, tolerability, and local tissue response of fully immune-protected ENCRT devices containing primary human islets in adults with Type 1 Diabetes. Included in assessments are vascular integration and immune cell exclusion.
4.5-5 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Assessment of IEQ (islet equivalent) population present in explants
Tidsramme: 4 months
The secondary objectives are to evaluate of the activity, function, and survival of the donor islets from the retrieved ENCRT-103-hPI through marker expression in histological sections.
4 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Exploratory functional outcomes
Tidsramme: 4 months
Characterize potential functional engraftment via device removal and fixation for histopathological analysis (post-explant).
4 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Encellin

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

6. januar 2027

Primær færdiggørelse (Anslået)

6. juli 2028

Studieafslutning (Anslået)

1. januar 2029

Datoer for studieregistrering

Først indsendt

24. juni 2026

Først indsendt, der opfyldte QC-kriterier

29. juni 2026

Først opslået (Faktiske)

2. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ENCRT-103-hPI
  • 2-IND-2026-1973-I-X (Andet bevillings-/finansieringsnummer: Breakthrough T1D)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

Participating institutions may restrict.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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