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Type 1 DiabetesEarly Phase 1NCT03728296

A Study of Autologous Induced Islet Body With Type 1 Diabetes

A Early Phase 1 study testing islet body in people with Type 1 Diabetes, run by Allife Medical Science and Technology Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a single centre、single arm、open-label study，to investigate the safety and efficacy of Autologous induced islet body With Type 1 diabetes Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
islet body
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Jan 2019to Jan 2021
Phase
Early Phase 1
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, 18 to 70 years old (including 18 and 70 years old)
  • Diagnosed as type I diabetes, the diagnostic criteria refer to the 1990 WHO diabetes diagnostic criteria:
  • （1）Diabetes symptoms (hyperglycemia caused by polydipsia, polyphagia, weight loss, itchy skin, blurred vision and other acute metabolic disorders) + random blood glucose ≥ 11.1nmol / L; （2）Fasting blood glucose ≥7.0mmol/L or 75g glucose meets 2-hour blood glucose ≥11.1mmol/L.
  • 3、Voluntary informed consent is given, agree to follow the trial treatment and visit plan.
  • Note: 2 is the venous plasma glucose level, if there is no diabetes symptoms, it is necessary to repeat the test on the next day.

Who cannot join

  • Patients with acute complications of diabetes: including diabetic ketosis, diabetic ketoacidosis, diabetes, hyperglycemia, hypertonic state, etc.
  • Patients with Severe bacterial and viral infections
  • patients are participating in other clinical trials and treating with other immune cellular products (DC, CIK, T, NK, and Car T products with CD19 or other targets)
  • Patients with severe cardiovascular and cerebrovascular disease (NYHA class 3-4) cannot cooperate with the study
  • Patients with severe liver dysfunction(liver function AST and ALT exceeded 2.5 times the normal upper limit).
  • Patients with kidney disease or moderate to severe renal insufficiency (renal function eGFR <60 ml/min/1.73 m2)
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  • Women in pregnancy (urine/blood pregnancy test positive) or lactation; men or women with pregnancy plans in the last year; patients are not guaranteed to take effective contraceptive measures during the trial;
  • patients were diagnosed as tumor or tumor chemotherapy, radiotherapy and acute uric acid nephropathy within 5 years.
  • Other circumstances that researchers do not consider suitable for research.
  • Withdrawal from trial, loss of follow-up or death due to other reasons
  • Incomplete data, affecting effectiveness and safety judges
  • Researchers believe that the need for termination of the trial is needed.

About this study

Official title: Clinical Study on the Safety and Efficacy of Autologous Induced Islet Body With Type 1 Diabetes

This is a single centre、single arm、open-label study，to investigate the safety and efficacy of Autologous induced islet body With Type 1 diabetes

Conditions
Type 1 Diabetes
Being tested
islet body
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • islet bodyBiological

    Transplanting islet bodies under the diaphragm

Study groups in NCT03728296
Study groupRoleWhat they receive
islet body treatment groupExperimentalNot described
Receives: Biological: islet body

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of treatment related adverse events as assessed by CTCAE v4.0

    Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2018
  2. Study startJan 2019 (estimated)
  3. Primary completionJan 2020 (estimated)
  4. Study completionJan 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Intervention model
Sequential
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03728296
Sponsor's protocol ID
islet body-01
Status last verified
Oct 2018
First submitted
31 Oct 2018
Last updated
2 Nov 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing islet body in people with Type 1 Diabetes, run by Allife Medical Science and Technology Co., Ltd..

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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of treatment related adverse events as assessed by CTCAE v4.0 (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03728296.

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 2 Nov 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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