ENCRT-103-hPI: Evaluation of an Immune-protected ENCRT-103-hPI Containing Primary Human Islets in Adults With Type 1 Diabetes, With and Without Standard-of-care Portal Vein Islet Infusion.
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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 different 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.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
British Columbia
-
Vancouver, British Columbia, Kanada
- Vancouver General Hospital
-
Huvudutredare:
- Michael Bleszynski, MD
-
-
Ontario
-
Toronto, Ontario, Kanada
- UHN
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Huvudutredare:
- Trevor Reichman, MD
-
Kontakt:
- Site coordinator, DDM
- Telefonnummer: 416-340-4800
- E-post: honey.lad@uhn.ca
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Enhetens genomförbarhet
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
Andra namn:
|
|
Experimentell: Cohort B: ENCRT-103-hPI only
Patients receive only an ENCRT implant (the intervention) and a drug for engraftment and immune management.
|
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Rate of device-related adverse events (AEs)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Assessment of IEQ (islet equivalent) population present in explants
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Exploratory functional outcomes
Tidsram: 4 months
|
Characterize potential functional engraftment via device removal and fixation for histopathological analysis (post-explant).
|
4 months
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ENCRT-103-hPI
- 2-IND-2026-1973-I-X (Annat bidrag/finansieringsnummer: Breakthrough T1D)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
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