NCT07126873 A Safety, Tolerability, and Efficacy Study of E-islet 01 in Participants With Type 1 Diabetes
| NCT ID | NCT07126873 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | EndoCell Therapeutics, Inc. |
| Condition | Diabetes Mellitus, Type 1 |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2025-08-11 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 21 participants in total. It began in 2025-08-11 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07126873 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Diabetes Mellitus, Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07126873 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07126873 currently recruiting?
Yes, NCT07126873 is actively recruiting participants. Contact the research team at mayanyan@endocell.cn for enrollment information.
Where is the NCT07126873 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07126873 clinical trial?
NCT07126873 is sponsored by EndoCell Therapeutics, Inc.. The trial plans to enroll 21 participants.
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