CLINICAL TRIAL

Allogenic Islet Cell Transplantation for Diabetes, Autoimmune

Recruiting · 18+ · All Sexes · Charlottesville, VA

Islet Transplant in Patients With Type I Diabetes

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About the trial for Diabetes, Autoimmune

Eligible Conditions
Diabetes Mellitus, Type 1 · Diabetes Mellitus

Treatment Groups

This trial involves 2 different treatments. Allogenic Islet Cell Transplantation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Allogenic Islet Cell Transplantation
BIOLOGICAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
At least 1 episode of severe hypoglycemia in the past 3 years
Reduced awareness of hypoglycemia
Must be a qualified candidate for pancreas transplant
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: within 1 year of transplant
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: within 1 year of transplant.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Allogenic Islet Cell Transplantation will improve 1 primary outcome and 3 secondary outcomes in patients with Diabetes, Autoimmune. Measurement will happen over the course of within 1 year of transplant.

Proportion of subjects with HbA1c less than or equal to 7.0%
WITHIN 1 YEAR OF TRANSPLANT
Measured by IV venous blood draw
Incidence of procedure related adverse events
WITHIN 1 YEAR OF TRANSPLANT
as evidenced by lack of bleeding during the procedure, incidence of portal vein thrombosis, incidence of biliary puncture during the procedure, incidence of wound complication for cases where laparotomy is performed, and incidence of increased transaminase levels >5 times upper limit of normal within 6 months.
Insulin independence achieved
WITHIN 1 YEAR OF TRANSPLANT
Measured by absence of exogenous insulin injection, HbA1c less than or equal to 7.0%, fasting capillary glucose level that does not exceed 140 mg/dl more than three times per week during a seven day period, and fasting plasma glucose levels less than or equal to 126 mg/dL
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
WITHIN 1 YEAR OF TRANSPLANT
An event with symptoms compatible with hypoglycemia in which the subject required assistance of another person and which was associated with either a blood glucose level of <50 mg/dl or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have there been any new discoveries for treating diabetes, autoimmune?

There have not been any significant breakthroughs in therapies for treating diabetes, autoimmune. However, it must be acknowledged that there are numerous medications available today which are effective, safe, and inexpensive, and many patients are able to obtain and afford them.

Anonymous Patient Answer

Is allogenic islet cell transplantation typically used in combination with any other treatments?

The majority of autologous and allogeneic islet cell transplantations in the Netherlands did not take into account any other treatment, in particular, other forms of immunosuppressive medication. The use of an immunosuppressive drug was not usually related to the outcome of the islet cell transplantation.

Anonymous Patient Answer

What are the signs of diabetes, autoimmune?

Diabetic ketoacidosis is a common symptom of diabetes. Other signs and symptoms of diabetes may include headaches, increased thirst, or feeling a 'pins and needles sensation' in the fingers or legs. An increased level of glycated haemoglobin (glycaemia) may be visible even on a blood test. Those diagnosed with diabetes face problems with their vision due to diabetic retinopathy. If you have symptoms of diabetes, see your doctor. Symptoms appear similar to signs of arthritis and can be misdiagnosed. People who have Type 1 diabetes, have a family history of the condition, or live with anyone with diabetes are at risk of having it themselves.

Anonymous Patient Answer

What is diabetes, autoimmune?

Diabetes, like thyroid disease, can be defined in terms of an abnormally high or low blood glucose level as well as in terms of a autoimmune disease like Graves' disease or diabetes mellitus. The latter type is most common in autoimmune-prone individuals, and thus, is often associated with the development of other autoimmune diseases such as, in particular, thyroid disease and type 1 diabetes mellitus.

Anonymous Patient Answer

How many people get diabetes, autoimmune a year in the United States?

Approximately 70 million will have been diagnosed with either diabetes mellitus, or type 1 or type 2 autoimmune diabetes in the year 2020. There are almost 2 million undiagnosed people with type 1 diabetes and almost 1.3 million undiagnosed people affected by diabetes that will be diagnosed by 2022.

Anonymous Patient Answer

What causes diabetes, autoimmune?

There is little information on causes of these autoimmune diseases, which suggests that there may be more than one cause for most of these common autoimmune diseases. The role of genetics, and environmental exposures are also not understood.

Anonymous Patient Answer

Can diabetes, autoimmune be cured?

Diabetic patients should have a structured and supervised follow-up and the potential risk of the patients is not low if they are well monitored and treated with hypoallergenic diet. The authors believe that these patients will get complete recovery from diabetes, autoimmune, and hypertension from the treatments.

Anonymous Patient Answer

What are common treatments for diabetes, autoimmune?

There are a few commonly used treatments for diabetes and autoimmune disease. These include weight loss and physical activity, but there is limited evidence that these management measures reduce the incidence or severity of complications.

Anonymous Patient Answer

Does diabetes, autoimmune run in families?

Diabetes and AITD do share similar and distinct characteristics, which suggest that they share common etiologic determinants and associated genes, and that shared genetic factors contribute to the two entities' risk. AITD cases may be associated with insulin resistance and increased risk of [type 2 diabetes](https://www.withpower.com/clinical-trials/type-2-diabetes).

Anonymous Patient Answer

What is the average age someone gets diabetes, autoimmune?

[In the general population, a median age of diabetes diagnosis is about 34 years old.] Because [most] people with diabetes develop symptoms in their 40s, this average age at diagnosis reflects a life course for most patients. While there may be some variation, the general pattern is that diabetes symptoms become more common after the age of 40 and that the [most] patients develop diabetes in their 50s. [About two thirds of diabetic patients have autoimmune hepatitis.] [About 40 percent of diabetic patients have some form of autoimmune diseases like diabetes, autoimmune thyroid disease, autoimmune hemolytic anemia, or celiac disease.] It is clear, therefore, that most people with diabetes will develop autoimmune diseases as they get older.

Anonymous Patient Answer

What is the primary cause of diabetes, autoimmune?

Patients with autoimmune diabetes have an increased risk for developing diabetes in comparison with the general population. However, the primary cause of diabetes may also be autoimmune disease. Therefore, a close control of autoimmune diabetes is important to prevent the development of the disease.

Anonymous Patient Answer

Does allogenic islet cell transplantation improve quality of life for those with diabetes, autoimmune?

Islet cell transplantation as primary treatment for persons with Type 1 diabetes achieves equivalent quality of life compared with conventional glucose-lowering therapy, especially for patients with diabetes for less than 2 years. Allocell transplantation treatment was found to be safe. The benefit was proportional to duration of diabetes prior to transplantation.

Anonymous Patient Answer
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