deltatrials
Recruiting PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT06575426

A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus

A Phase I/IIa, Single Site, Open-Label, Ascending Dose Study to Evaluate the Safety and Efficacy of OPF-310 [Encapsulated Porcine Islet Cells for Xenotransplantation] in Subjects With Type 1 Diabetes Mellitus

Sponsor: Otsuka Pharmaceutical Factory, Inc.

Interventions OPF-310
Updated 8 times since 2024 Last updated: Feb 26, 2026 Started: Jun 10, 2025 Primary completion: Jun 30, 2027 Completion: Jun 30, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT06575426, this PHASE1/PHASE2 trial focuses on Autoimmune Diseases and Diabetes Mellitus, Type 1 and remains actively recruiting participants. Sponsored by Otsuka Pharmaceutical Factory, Inc., it has been updated 8 times since 2025, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Sep 2024 – ~Apr 2025 · 7 months · monthly snapshotNot Yet Recruiting~Apr 2025 – ~May 2025 · 30 days · monthly snapshot~May 2025 – ~Jul 2025 · 2 months · monthly snapshotRecruiting~Jul 2025 – ~Sep 2025 · 2 months · monthly snapshotRecruiting~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – ~Feb 2026 · 4 months · monthly snapshotRecruiting~Feb 2026 – ~Mar 2026 · 28 days · monthly snapshot~Mar 2026 – present · 2 months · monthly snapshotRecruiting

Change History

8 versions recorded
  1. Mar 2026 — Present [monthly]

    Recruiting PHASE1/PHASE2

  2. Feb 2026 — Mar 2026 [monthly]

    Recruiting PHASE1/PHASE2

  3. Oct 2025 — Feb 2026 [monthly]

    Recruiting PHASE1/PHASE2

  4. Sep 2025 — Oct 2025 [monthly]

    Recruiting PHASE1/PHASE2

  5. Jul 2025 — Sep 2025 [monthly]

    Recruiting PHASE1/PHASE2

Show 3 earlier versions
  1. May 2025 — Jul 2025 [monthly]

    Recruiting PHASE1/PHASE2

  2. Apr 2025 — May 2025 [monthly]

    Recruiting PHASE1/PHASE2

    Status: Not Yet RecruitingRecruiting

  3. Sep 2024 — Apr 2025 [monthly]

    Not Yet Recruiting PHASE1/PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Otsuka Pharmaceutical Factory, Inc.
Data source: Otsuka Pharmaceutical Factory, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations