Diabetes Mellitus, Type 1Phase 1/2NCT07126873
A Safety, Tolerability, and Efficacy Study of E-islet 01 in Participants With Type 1 Diabetes
A Phase 1/2 study testing Allogeneic Human E-islet (E-islet 01) in people with Diabetes Mellitus, Type 1 and Impaired Hypoglycemic Awareness, run by EndoCell Therapeutics, Inc. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness, Severe Hypoglycemia
- What is being tested?
- Allogeneic Human E-islet (E-islet 01)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2025to 31 Dec 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality
Hao Yin, 13901677738, yinhaoshanghai@163.com
About this study
Official title: 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
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
- Being tested
- Allogeneic Human E-islet (E-islet 01)
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Human E-islet (E-islet 01)Biological
Allogeneic Human E-islet (E-islet 01), Infused into the hepatic portal vein
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic Human E-islet (E-islet 01) | Experimental | Not described Receives: Biological: Allogeneic Human E-islet (E-islet 01) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: 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
Measured: At 1 year after E-islet 01 infusion
Secondary outcomes (3)
Proportion of Participants who are Time in range (TIR) >70%
Measured: At 1 year after E-islet 01 infusion
Number of participants with increase in fasting C-peptide and stimulated C-peptide from baseline
Measured: At 1 year after E-islet 01 infusion
Proportion of Participants who are Insulin Independent or Reduction in Exogenous Insulin
Measured: At 1 year after E-islet 01 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start11 Aug 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EndoCell Therapeutics, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126873
- Sponsor's protocol ID
- ENDOCELL-T1DM-101
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07126873
- Acronym / sponsor ID
- ENDOCELL-T1DM-101
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- EndoCell Therapeutics, Inc.University, hospital or other
- Study start
- 11 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogeneic Human E-islet (E-islet 01) | Experimental | Biological: Allogeneic Human E-islet (E-islet 01) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Willing and able to conduct self-blood glucose monitoring as required, with good compliance
- Voluntarily participate and sign the informed consent form
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic Human E-islet (E-islet 01)Allogeneic Human E-islet (E-islet 01), Infused into the hepatic portal vein | Biological | Allogeneic Human E-islet (E-islet 01) |
Primary outcome
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)
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 infusion
3 secondary outcomes
Proportion of Participants who are Time in range (TIR) >70%
Time frame: At 1 year after E-islet 01 infusion
Number of participants with increase in fasting C-peptide and stimulated C-peptide from baseline
Time frame: At 1 year after E-islet 01 infusion
Proportion of Participants who are Insulin Independent or Reduction in Exogenous Insulin
Time frame: At 1 year after E-islet 01 infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Allogeneic Human E-islet (E-islet 01) in people with Diabetes Mellitus, Type 1 and Impaired Hypoglycemic Awareness, run by EndoCell Therapeutics, Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yanyan ma (+8618621591910, mayanyan@endocell.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.