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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 39 words Secondary endpoints revised (12)v11 Show 1 more changeShow less
    • Secondary endpoints revised (12)

    See this version in full on ClinicalTrials.gov ↗

  2. Eligibility criteria expanded, about 65 words Secondary endpoints revised (12)v10 Show 1 more changeShow less
    • Secondary endpoints revised (12)

    See this version in full on ClinicalTrials.gov ↗

  3. Study site revisedv9 See this version in full on ClinicalTrials.gov ↗
  4. Secondary endpoints: 16 to 12 Eligibility criteria shortened, about 3 wordsv8 Show 1 more changeShow less
    • Eligibility criteria shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv7
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  1. Start date: Apr 1, 2025 to Jun 10, 2025v6
  2. Eligibility criteria expanded, about 95 words Study title revisedv5 Show 1 more changeShow less
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  3. Study title shortened, about 2 wordsv4 See this version in full on ClinicalTrials.gov ↗
  4. Site contact updatedv3
  5. Trial status: Not Yet Recruiting to Recruiting Start date: Dec 28, 2024 to Apr 1, 2025 · Study sites: 0 to 1 · Interventions: OPF-310 (Drug) to OPF-310 (Combination Product) · 1 morev2 Show 4 more changesShow less
    • Start date: Dec 28, 2024 to Apr 1, 2025
    • Study sites: 0 to 1
    • Interventions: OPF-310 (Drug) to OPF-310 (Combination Product)
    • Eligibility criteria expanded, about 47 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Astex Pharmaceuticals
103 trials monitored
See 3 trials at risk
Diabetes
4,286 trials monitored
See 187 trials at risk
Type 1 Diabetes
853 trials monitored
See 38 trials at risk
This study is First In Human study for Encapsulated Porcine Islet Cells for Xenotransplantation (OPF-310). The purpose of this study to assess the safety, tolerability, and efficacy of OPF-310 transplantation and to define the recommended Phase 2 dose (RP2D) in adult subjects with unstable Type 1 Diabetes Mellitus (T1DM) and a level 3 (severe) hypoglycemic episode at least three times within the 1 year prior to enrollment despite treatment with a closed loop system (CLS) for at least 6 months.
Trial Details
NCT Number NCT06575426
Lead Sponsor Otsuka Pharmaceutical Factory, Inc.
Conditions Diabetes Mellitus, Type 1, Hypoglycemia, Islet Cell Transplantation, Type 1 Diabetes, Type 1 Diabetes Mellitus, T1D, T1DM, T1DM - Type 1 Diabetes Mellitus +9 more
Enrollment 13 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov