Phase 2 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 aged 35 to 65 years old at the time of signing the consent form
• People who have been officially diagnosed with type 1 diabetes for at least 5 years, diagnosed according to American Diabetes Association standards
• People whose type 1 diabetes is unstable and not well-controlled despite using a specific closed-loop insulin system (a continuous glucose monitor paired with a compatible insulin pump) managed by a qualified diabetes care team for at least 6 months (confirm with trial site for which specific devices apply)
• People who have had at least three severe low blood sugar episodes in the past year that required help from another person to recover, as recorded in medical records or a personal log
• OR people who have had at least one such severe low blood sugar episode in the past year AND score 4 or higher on a test that measures awareness of low blood sugar (called the Clarke Score)
• OR people whose continuous glucose monitor data shows blood sugar levels below 70 mg/dL more than 1% of the time AND who score 4 or higher on the Clarke Score
• People whose pancreas produces little to no insulin, confirmed by a specific blood test (C-peptide level below 0.3 ng/mL after a test meal, or undetectable when fasting)
• People with a blood sugar control measure (HbA1c) of 9.0% or below
• People who are willing and able to use contraception as required by local rules for clinical trial participants
• People who agree to health check-ins for the rest of their life after the procedure
• People who are able to read, understand, and sign a consent form

Who may not be able to join:

• People whose bodies have shown resistance to insulin, meaning they needed an average of 0.8 units or more of insulin per kilogram of body weight per day during the week before enrolment
• People diagnosed with certain other forms of diabetes, including LADA, Flatbush diabetes, or MODY
• People with a blood inflammation marker (CRP) of 10 mg/L or higher
• People with an unstable thyroid condition where the thyroid-stimulating hormone (TSH) level is below the normal range (those with mildly abnormal TSH levels may be able to reapply once levels return to normal — confirm with trial site)
• People who have had any cancer in the past 5 years, except for certain common skin cancers (basal cell or squamous cell carcinoma)
• People who test positive for HIV, hepatitis B, or hepatitis C
• People with active or untreated advanced diabetic eye disease affecting the retina (those who have been successfully treated may be able to reapply — confirm with trial site)
• People who have had a limb amputation due to poor blood circulation in the past 12 months
• People with a history of moderate to severe heart failure (New York Heart Association Class II, III, or IV) or ongoing irregular heart rhythm (chronic atrial fibrillation)
• People with serious lung conditions such as COPD or asthma who have been hospitalised for a worsening episode, have needed a breathing machine at any point, or require long-term steroid tablets
• People with a high level of protein in their urine indicating significant kidney damage (albumin-to-creatinine ratio above 300 mg/g)
• People with significantly reduced kidney function (eGFR below 30 ml/min)
• People taking blood-thinning medication other than aspirin, or whose blood clotting test result (PT-INR) is above 1.5
• People taking steroid medications to treat adrenal insufficiency
• People who have previously had a severe infection affecting the entire abdominal cavity (pan-peritonitis)
• People with a history of heart or stroke-related conditions, including a heart attack in the past year, blocked coronary arteries that cannot be fixed, signs of reduced blood flow to the heart on cardiac testing, or heart failure above a mild level
• People with certain bone marrow or blood cell disorders, such as aplastic anaemia or myelodysplastic syndrome
• People who received a blood transfusion in the past 90 days, who expect to need surgery during the one-year study that may involve a transfusion, or who have donated blood in the past 90 days
• People who have previously received an organ, skin, or other tissue transplant from another person or an animal
• People currently taking immunosuppressant medications
• People who have had previous abdominal surgery, unless it was an uncomplicated appendix removal, gallbladder removal, exploratory keyhole surgery, or hernia repair performed more than 12 weeks before enrolment
• People taking any blood sugar–lowering medication other than insulin
• People taking acetaminophen (paracetamol) or hydroxycarbamide
• People who have taken part in another clinical trial or used an experimental treatment within 12 weeks before enrolment, or within 5 half-lives of that experimental product — whichever period is longer
• People with a known allergy to certain antibiotics used in making the study treatment (Amphotericin B, Cefazolin, Ciprofloxacin, or Gentamicin)
• People with a known allergy to insulin (including pork-derived insulin), pork products, or alginate/seaweed
• People with a high level of pre-formed immune antibodies (Panel Reactive Antibodies above 80%) that could react against donor tissue
• People with an active addiction to drugs, substances, or alcohol
• People with a Body Mass Index (BMI) above 27 kg/m²
• People with any other condition — including dementia, a psychiatric disorder, or a history of not following through with appointments or treatments — that the trial doctor believes could affect safe participation in the study

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