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Cell Therapy
Islet Transplant for Type 1 Diabetes
Phase 1 & 2
Waitlist Available
Research Sponsored by Kenneth Brayman, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 year of transplant
Awards & highlights
Study Summary
This trial is testing whether islet transplantation is safe and can better control blood sugar than state-of-the-art insulin treatment in people with type 1 diabetes who have had severe hypoglycemic episodes.
Eligible Conditions
- Type 1 Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 1 year of transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 year of transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of procedure related adverse events
Secondary outcome measures
Insulin independence achieved
Proportion of subjects free of severe hypoglycemic events between 6 and 12 months from the time of first islet cell infusion or from the time insulin therapy is withdrawn
Proportion of subjects with HbA1c less than or equal to 7.0%
Trial Design
1Treatment groups
Experimental Treatment
Group I: Allogenic Islet Cell TransplantationExperimental Treatment1 Intervention
Transplantation of allogenic islet cell will be given to eligible patients, up to three times during the study, using cell quantities based on body weight.
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Who is running the clinical trial?
Kenneth Brayman, MDLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a recent heart attack, have uncorrectable blockages in your heart arteries, or show signs of poor blood flow to the heart during a heart test.You are currently using alcohol or drugs in a way that may cause harm.You have a history of not following the study rules.You have a current infection with hepatitis C, hepatitis B, or HIV.You have had tuberculosis in the past or currently have it.You have had any type of cancer, except for skin cancer.You had a stroke in the last 6 months.Your liver function test results are not normal at the start of the study.Your HbA1c level is higher than 12%.You have high levels of fats in your blood.You are taking coumadin or other medications that prevent blood clots.You have stomach ulcers with symptoms.Your kidneys are not filtering waste as well as they should be.Having high levels of albumin in the urine.Your baseline hemoglobin level is less than 12 grams per deciliter.You have a history of Factor V deficiency.If you have a recent episode of pancreatitis on top of an ongoing pancreas problem.You received a live vaccine within the past 2 months.You currently have a blood clotting problem.You need more than 0.7 units of insulin per kilogram of body weight each day.You have a history of Addison's disease.You are allergic to the dye used for X-ray tests.You have symptoms from gallstones in your gallbladder.You have ongoing severe diarrhea, vomiting, or other stomach problems that could make it hard for you to take pills.You are not able to recognize when your blood sugar gets too low.You have experienced very low blood sugar at least once in the last 3 years.You must be eligible for a pancreas transplant.You weigh more than what is considered healthy for your height.Your body's response to a hormone called glucagon after fasting.You have a history of untreated severe eye disease.You have had an organ transplant in the past, except for an islet transplant.You have taken non-insulin diabetes medication within the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Allogenic Islet Cell Transplantation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
Type 1 Diabetes Patient Testimony for trial: Trial Name: NCT03698396 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the overall enrollment of this experiment?
"Affirmative. Per the details available on clinicaltrials.gov, this clinical trial is actively searching for volunteers to participate. The study was initially published on August 1st 2019 and most recently updated on July 29th 2020 with a recruitment goal of 10 participants from one single site."
Answered by AI
Is it possible to enroll in this trial at present?
"Per information on clinicaltrials.gov, this medical experiment is searching for test subjects at the present moment. Initially posted in August 2019 and revised as recently as July 2020."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
Virginia
How old are they?
18 - 65
What site did they apply to?
University of Virginia
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
+17577603941 better quality of life. I would love to find some relief. on this illness.
PatientReceived 1 prior treatment
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