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Tests treatment safety and results for Diabetes Mellitus, Type 1
Official title A Safety, Tolerability, and Efficacy Study of E-islet 01 in Participants With Type 1 Diabetes
ClinicalTrials.gov ID: NCT07126873
What this study is testing
What is Allogeneic Human E-islet (E-islet 01)?
Allogeneic Human E-islet (E-islet 01) is an investigational medicine, being studied as a potential treatment for diabetes mellitus, type 1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- Uncontrolled systemic infections, including but not limited to pulmonary tuberculosis, active hepatitis, a history of positive hepatitis B surface...
- 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...
- Other situations judged by the investigator as unsuitable for participation in the trial
See the full eligibility 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:
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.