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Gastrin + Islet Transplant for Type 1 Diabetes
Study Summary
This trial will evaluate if the combination of these two products can help patients with type 1 diabetes who have difficulty controlling their blood sugar levels with insulin make insulin again and improve blood sugar control.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I currently have an active stomach ulcer.You are actively abusing alcohol, drugs, or smoking cigarettes, unless you have been abstinent for more than 3 months.I have had an organ or tissue transplant.You do not have antibodies for the Epstein-Barr virus.I have anemia or another blood disorder needing treatment.I have not received any live vaccines in the last 60 days.I use more than 1 unit of insulin per kilogram of my body weight daily.Your blood sugar levels are not stable and you have frequent low blood sugar episodes, are unaware of low blood sugar symptoms, have had severe low blood sugar episodes in the past year, or have erratic blood sugar levels that affect your daily life.I am between 18 and 68 years old.I am committed to following a strict post-transplant care plan, including medication adherence and health monitoring.You have a body mass index (BMI) higher than 33.I have had Type 1 diabetes for over 5 years with specific C-peptide levels.I have a high risk of bleeding or am on long-term blood thinners.I am on long-term medication for a chronic illness that cannot be used with the trial drugs.My blood pressure is high (140/90 or more) despite taking medication.My kidney function is low, and I have high levels of protein in my urine.I have an eye condition where new blood vessels are growing abnormally.You have a mental illness that is not being treated, or even with treatment, it may make it hard for you to follow the study rules.I am not pregnant, not planning to become pregnant, and willing to use effective birth control if of childbearing potential.I do not have serious heart or blood vessel diseases that can't be fixed with surgery.I have had cancer before, but it was either skin cancer that was completely removed or a non-invasive cervical cancer.My cholesterol or triglycerides are high despite treatment.Your white blood cell count is less than 3,000 per microliter.I do not have any current severe infections or long-term infections like TB, HIV, or hepatitis.I have not followed my doctor's advice on treatment recently.My health insurance does not cover post-study care costs.I have had a gastric bypass surgery.My liver function tests are not normal, or I have serious liver or gallbladder issues.
- Group 1: Single Arm Study
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What other empirical investigations have been conducted involving Allogenic Human Islet Cells?
"Presently, the search for Allogenic Human Islet Cells has yielded 4 live studies with none in their final clinical phase. Primarily based in Duarte, California; these investigations are also taking place at four other medical sites."
Is the enrollment period still open for this experiment?
"Affirmative. Clinicaltrials.gov records indicate that this investigation, initially posted on July 7th 2019, is actively recruiting patients at present. A total of 20 individuals from one site are needed for the trial's completion."
How many subjects are currently engaged in the research?
"Affirmative. As evidenced on clinicaltrials.gov, this experiment is actively seeking participants and has been since July 7th 2019; the trial was last modified on February 16th 2022. The researchers need to find 20 patients from a single site for their study."
Is participation in the trial open to seniors aged seventy-five or older?
"In accordance with the requirements for this research project, potential participants must be older than 18 and younger than 68."
Am I able to partake in this research experiment?
"Those who meet the criteria of having diabetes, an autoimmune disorder, and being between 18 to 68 years old may be accepted into this trial. The medical team is currently seeking 20 individuals for enrollment."
For what maladies are Allogenic Human Islet Cells routinely prescribed?
"Allogenic Human Islet Cells is frequently used to ameliorate anti-platelet syndromes. It can also offer relief for conditions such as peptic ulcer, gastric ulcer and gastroesophageal reflux disease."
Who else is applying?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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