Early Phase 1 Type 1 Diabetes Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have signed a consent form agreeing to take part in the study
• People who have been diagnosed with type 1 diabetes for at least 5 years, were diagnosed before the age of 18, and have had at least one blood sugar control reading (HbA1c) of 70 mmol/mol or higher recorded in their medical records or a Swedish national diabetes registry in the past 5 years
• People who are actively managing their diabetes with a continuous or scanning glucose monitor used at least 3 times per day on average, plus 3 or more insulin injections per day or an insulin pump, under the care of a specialist diabetes doctor and diabetes nurse at a specialist clinic for at least the past 12 months
• People whose pancreas produces no measurable insulin of its own, confirmed by a specific food-based test (called a mixed meal tolerance test)
• People who test positive for certain diabetes-related antibodies (GAD or IA2) at the screening appointment
• People who are between 30 and 45 years old at the time of enrolment
• People whose HbA1c (a measure of blood sugar control over time) is 70 mmol/mol or higher
• People whose daily insulin needs are less than 1 unit per kilogram of body weight
• People who weigh less than 80 kg
• Women who could become pregnant must agree to use effective contraception until one year after receiving the study treatment (specific contraception methods are listed in the trial's guidelines)
• Men must agree to use effective contraception (condoms) throughout the trial and not intend to father a child until one year after receiving the study treatment

Who may not be able to join:

• People who have previously had an organ transplant
• People who are currently taking medication that suppresses the immune system for any condition
• People who have ever been diagnosed with cancer
• People who have taken part in another clinical trial or used an experimental treatment within the past 4 weeks
• People who have used any diabetes medication other than insulin within the past 4 weeks
• People who have an active infection, including tuberculosis, HIV, hepatitis B, or hepatitis C
• People whose liver function blood test results fall outside the normal range used at Uppsala University Hospital
• People who show signs of infection with HTLV-I or HTLV-II viruses
• People who are pregnant, breastfeeding, or planning to become pregnant
• People with moderate to severe kidney disease (where the kidneys are functioning below a certain level, confirmed by blood tests)
• People with a history of heart disease, or who show signs of heart disease at their screening appointment
• People with certain immune system sensitivities related to tissue proteins (HLA immunisation or MIC A/B immunisation) (confirm with trial site)
• People with a known autoimmune condition other than type 1 diabetes, such as Hashimoto's thyroid disease
• People who have received a live vaccine within 6 months before the transplant procedure
• People whose levels of certain diabetes-related antibodies are above specific thresholds, or who test positive for ZnT8 antibodies (confirm with trial site for exact values)
• People with untreated advanced diabetic eye disease affecting the retina
• People with a significant ongoing psychiatric condition that the lead doctor believes could affect safe participation or willingness to follow the study requirements
• People with an ongoing or recent history of alcohol or drug misuse, or a history of not following medical treatment as directed
• People with a known allergy to ciprofloxacin, gentamicin, or amphotericin, as these are used in making the study treatment
• People with any other condition that the lead doctor believes makes participation unsafe

Important: Always verify eligibility with the trial site directly before applying.