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
Qualifiers
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
Treatments tested in this trial
- Allogeneic Human E-islet (E-islet 01)
Treatment groups
21 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov