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

Официальное название

A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of E-islet 01 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia

Обзор

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

Вмешательства

• Биопрепарат Allogeneic Human E-islet (E-islet 01)
  Allogeneic Human E-islet (E-islet 01), Infused into the hepatic portal vein

Первичные конечные точки

• Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: From E-islet 01 infusion to end of study (up to 5 years)]
• Proportion of Participants Free of Severe Hypoglycemic Events With Either a Glycated Haemoglobin (HbA1c) <7.0% or a ≥ 1% Reduction in Glycosylated hemoglobin(HbA1c) From Baseline [Срок оценки: At 1 year after E-islet 01 infusion]

Вторичные конечные точки (3)

• Proportion of Participants who are Time in range (TIR) >70% [Срок оценки: At 1 year after E-islet 01 infusion]
• Number of participants with increase in fasting C-peptide and stimulated C-peptide from baseline [Срок оценки: At 1 year after E-islet 01 infusion]
• Proportion of Participants who are Insulin Independent or Reduction in Exogenous Insulin [Срок оценки: At 1 year after E-islet 01 infusion]

Критерии участия

Критерии включения

• 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:

• At least one episode of documented severe hypoglycemia in the 12 months prior to enrollment;
• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Changzheng Hospital — Шанхай

Идентификаторы

NCT: NCT07126873 · ENDOCELL-T1DM-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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