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A Safety, Tolerability, and Efficacy Study of E-islet 01 in Participants With Type 1 Diabetes

RecruitingPhase 1, Phase 2Ages 18 Years - 75 YearsAllEndoCell Therapeutics, Inc.
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In plain words

What the trial is, and whether it could suit you

This study will evaluate the safety, tolerability and efficacy of E-islet 01 in participants with Type 1 diabetes mellitus (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Clinical history of Type 1 Diabetes with \> 5 years of duration * 2-hour C-peptide level \<0.3 ng/mL after a mixed meal stimulation test * Under continuous insulin therapy, Participants have at least one of the following conditions: 1. At least one episode of documented severe hypoglycemia in the 12 months prior to enrollment; 2. Unaware hypoglycemia evaluated using the Clarke scoring system * Willing and able to conduct self-blood glucose monitoring as required, with good compliance * Voluntarily participate and sign the informed consent form Exclusion Criteria: * Uncontrolled systemic infections, including but not limited to pulmonary tuberculosis, active hepatitis, a history of positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (TP-Ab). * History of malignancy within the past 5 years or undergoing antitumor treatment * Participation in other clinical trials in the 3 months or islet cell transplant, organ transplant, or cell therapy in the 12 months prior to enrollment * Other situations judged by the investigator as unsuitable for participation in the trial
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What it tests

  • Allogeneic Human E-islet (E-islet 01)
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Where

1 site
Shanghai Changzheng Hospital
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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