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Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Phase: Phase 2/3 to Phase 3v7 Show 10 more changesShow less
    • Enrollment target: 50 to 80
    • Primary completion date: Oct 20, 2024 to Oct 20, 2027
    • Primary endpoint revised
    • Study completion date: Jun 20, 2025 to Dec 20, 2028
    • Secondary endpoints: 4 to 7
    • Study description shortened, about 61 words
    • Study sites revised (2)
    • Study arms: 2 to 1
    • Eligibility criteria shortened, about 2 words
    • Collaborators shortened, about 3 words
  2. Primary completion date: Mar 20, 2023 to Oct 20, 2024
    • Study completion date: Mar 20, 2024 to Jun 20, 2025
    v6
  3. Trial status: Not Yet Recruiting to Recruitingv5 Show 5 more changesShow less
    • Start date changed from estimate of Oct 4, 2021 to Sep 20, 2022
    • Study sites: 1 to 2
    • Primary completion date: Oct 30, 2022 to Mar 20, 2023
    • Study completion date: Dec 30, 2022 to Mar 20, 2024
    • Publications: 4 to 5
  4. Primary completion date: Oct 31, 2021 to Oct 30, 2022v4 Show 5 more changesShow less
    • Start date: Jan 22, 2020 to Oct 4, 2021
    • Study completion date: Dec 20, 2021 to Dec 30, 2022
    • Eligibility criteria revised
    • Site contact updated
    • Study arms: 1 to 2
  5. Start date: Nov 1, 2019 to Jan 22, 2020v3
  6. Primary endpoint revised
    • Secondary endpoints revised (4)
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Type 1 diabetes (T1D) is a T cell-mediated autoimmune disease that causes a deficit of pancreatic islet beta cells. Millions of individuals worldwide have T1D, and incidence increases annually. Several recent clinical trials point to the need for an approach that produces comprehensive immune modulation at both the local pancreatic and systemic levels. Stem Cell Educator (SCE) therapy offers comprehensive immune modulation at both the local and systemic levels in T1D by using a patient's own immune cells (including platelets) that are "educated" by cord blood stem cells. Tested clinically in more than 300 patients, SCE therapy has shown lasting reversal in autoimmunity in T1D patients, including improved C-peptide levels, reduced median glycated hemoglobin A1C (HbA1C) values, and decreased median daily usage of insulin. SCE therapy circulates a patient's blood through a blood cell separator, briefly cocultures the patient's immune cells with adherent Cord Blood Stem Cells (CB-SC) in vitro, and returns the "educated" autologous immune cells to the patient's circulation.
Trial Details
NCT Number NCT04011020
Lead Sponsor Throne Biotechnologies Inc.
Conditions
(from sponsor)		 Type 1 Diabetes
Related terms Diabetes Mellitus, Type 1
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov