A Safety, Tolerability, and Efficacy Study of E-islet 01 in Participants With Type 1 Diabetes
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEndoCell Therapeutics, Inc.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
At least one episode of documented severe hypoglycemia in the 12 months prior to enrollment;
Unaware hypoglycemia evaluated using the Clarke scoring system
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
Allogeneic Human E-islet (E-islet 01)
Biological/VaccineAllogeneic Human E-islet (E-islet 01), Infused into the hepatic portal vein
Treatment groups
21 Participants
are divided into 1 treatment groupGroup A: Allogeneic Human E-islet (E-islet 01)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame
From E-islet 01 infusion to end of study (up to 5 years)2
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
Time frame
At 1 year after E-islet 01 infusionSecondary outcomes
1
Proportion of Participants who are Time in range (TIR) >70%
Time frame
At 1 year after E-islet 01 infusion2
Number of participants with increase in fasting C-peptide and stimulated C-peptide from baseline
Time frame
At 1 year after E-islet 01 infusion3
Proportion of Participants who are Insulin Independent or Reduction in Exogenous Insulin
Time frame
At 1 year after E-islet 01 infusionSponsors and contacts
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Source ClinicalTrials.gov