Phase 2 Type 1 Diabetes Trial, Recruiting

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

Who might be able to join this trial:

• You must be able to understand the study and sign a consent form agreeing to take part
• You must be between 18 and 35 years old
• You must have been diagnosed with Type 1 diabetes within the last year, and still have some remaining insulin-producing function shown by a specific blood test (confirm with trial site)
• Your Type 1 diabetes diagnosis must meet standard medical guidelines and be confirmed by at least two specific diabetes-related antibodies in your blood (confirm with trial site)
• You must be mentally stable and able to follow the study's requirements
• You must be willing to manage your diabetes following standard medical care guidelines
• Your kidneys must be functioning above a certain level, shown by a blood test (confirm with trial site)
• If you are a woman who could become pregnant, you must have a negative pregnancy test when you enter the study
• Both men and women who could have children must agree to use two FDA-approved forms of birth control for the full two years of the study
• You must have veins accessible enough to allow the required blood draws throughout the study

Who may not be able to join:

• You are unwilling or unable to give consent or follow the study requirements
• Your BMI is above 28
• Your long-term blood sugar control measure (HbA1c) is above 9%
• You have poorly controlled high blood pressure (above 140/90 mmHg)
• You have any history of heart disease, heart attack, heart failure, or abnormal results from heart tests
• You have liver disease, high blood pressure in the liver, any blood clotting disorder, or are on long-term blood thinners (except low-dose aspirin)
• You have gallstones causing symptoms, pancreatitis, or an active stomach ulcer
• You have uncontrolled thyroid disease shown by abnormal thyroid hormone levels in your blood
• Certain blood test results fall outside acceptable ranges, including low red or white blood cells, abnormal liver enzymes, high cholesterol, or high triglycerides (confirm with trial site)
• You have evidence of a significant ongoing infection such as hepatitis B or C, tuberculosis, or HIV
• You currently have an active infection such as a respiratory, urinary, or stomach/gut infection
• You have an eating disorder
• You are using diabetes medications other than insulin, or medications that affect blood sugar levels
• You have received a live vaccine within 6 weeks of joining the study
• You have taken part in a previous clinical trial (not including observation-only studies)
• You are currently taking or have recently taken (within 3 months) immune-suppressing or immune-modifying medications
• You have a history of cancer, except for certain minor skin cancers
• You have a history of a stomach-emptying condition (gastroparesis) or other serious digestive disease
• You have received an organ or tissue transplant from another person
• You have a current or self-reported problem with drug or alcohol misuse
• You have a medical, mental, or social condition that the lead researcher feels would make it unsafe or difficult for you to complete the trial
• You are pregnant or breastfeeding, or are unwilling or unable to use reliable contraception for the full two years of the study
• You are unable to complete the assessments required by the study
• You have a known history of severe allergic reactions, including to heparin or the study treatment (CELZ-201) or its ingredients
• The trial investigator believes the trial is not in your best interest or considers you unsuitable for any reason
• You currently have COVID-19 confirmed by a test or show signs of active infection
• You have an allergy to iodine contrast dye or anesthesia
• You (as a female) are pregnant, nursing, planning to become pregnant, or unwilling to follow contraception requirements during the study
• You (as a male) have a female partner planning to become pregnant with you during the study, or you are unwilling to follow contraception requirements

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