CLINICAL TRIAL

Islet Cell Transplant for Unconsciousness

Waitlist Available · 18+ · All Sexes · Chicago, IL

This study is evaluating whether islet transplantation is safe and effective for treating type 1 diabetes.

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About the trial for Unconsciousness

Eligible Conditions
Unconsciousness · Severe Hypoglycemic Unawareness · Type 1 Diabetes Mellitus

Treatment Groups

This trial involves 2 different treatments. Islet Cell Transplant 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 3 and have had some early promising results.

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

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Islet Cell Transplant
2004
Completed Phase 2
~10

Side Effect Profile for Islet Cells + Etanercept + Exenatide

Islet Cells + Etanercept + Exenatide
Show all side effects
Temporary nausea, vomiting, and weight loss
100%
Transient anemia
100%
Increased creatinine
33%
Intraperitoneal hematoma
17%
Scalene muscle myonecrosis and vertebral osteomyelitis
17%
Intrahepatic hematoma
17%
Irregular menstrual bleeding and ruptured ovarian cyst
0%
This histogram enumerates side effects from a completed 2020 Phase 1 & 2 trial (NCT00566813) in the Islet Cells + Etanercept + Exenatide ARM group. Side effects include: Temporary nausea, vomiting, and weight loss with 100%, Transient anemia with 100%, Increased creatinine with 33%, Intraperitoneal hematoma with 17%, Scalene muscle myonecrosis and vertebral osteomyelitis with 17%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Mentally stable and able to comply with the procedures of the study protocol
Patients who have been followed by a qualified physician for diabetes management for a minimum of 12 months
At least one episode of severe hypoglycemia in the past 12 months
Male and female patients age 18-65 years of age at consent
A Clarke score of 4 or more defining reduced awareness of hypoglycemia
Or, previous islet cell transplant recipients who have returned to partial or full insulin usage and are taking maintenance immunosuppression medications.
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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: Two years after the final islet transplant.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Two years after the final islet 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 Islet Cell Transplant will improve 1 primary outcome and 2 secondary outcomes in patients with Unconsciousness. Measurement will happen over the course of Two years after the final islet transplant..

To relate clinical transplant outcomes based upon islet quantity/quality to organ donor characteristics
TWO YEARS AFTER THE FINAL ISLET TRANSPLANT.
To assess the proportion of insulin-independent subjects at two years after the final islet transplant.
To demonstrate the safety and efficacy of islet transplantation under alemtuzumab induction for treatment of Type-1 Diabetes (T1D) in subjects with hypoglycemia unawareness and a history of severe hypoglycemic episodes.
TWO YEARS AFTER THE FINAL ISLET TRANSPLANT.
To assess the efficacy of islet cell transplantation under alemtuzumab induction immunosuppression on the proportion of subjects with a change in HbA1c and free of severe hypoglycemic events through two years after the final islet transplant.
To relate clinical transplant outcomes based upon islet quantity/quality to organ donor characteristics.
TWO YEARS AFTER THE FINAL ISLET TRANSPLANT.
To compare islet graft outcome between alemtuzumab induction and historical anti-thymocyte induction groups.

Who is running the study

Principal Investigator
D. B.
Daniel Borja-Cacho, Principal Investigator
Northwestern University

Patient Q & A Section

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

What are the signs of unconsciousness?

In the light of these signs, and the symptoms outlined, a clinician can help determine the presence and possible causes for unconsciousness. Furthermore, once the cause of unconsciousness has been determined, the clinician can help to establish the course of treatment for conscious patients.

Anonymous Patient Answer

What is unconsciousness?

Although unconsciousness may occur in most of the cases analyzed, there is an important element of wakeful consciousness. The occurrence of this element in the cases described is highly significant.

Anonymous Patient Answer

How many people get unconsciousness a year in the United States?

The incidence of the different categories of unconsciousness varies significantly across the entire population. The rates of transient unconsciousness and coma are highest among hospitalized people aged 65 years and older, and the incidence of persistent unconsciousness in the group with the highest comorbidity is also higher for persons aged 65 years and older. The incidence of persistent unconsciousness seems to be influenced by age and comorbidity.

Anonymous Patient Answer

What causes unconsciousness?

In all probability, the cause of unconsciousness is an abnormality of the brain and/or spinal cord, resulting in a disruption of the integration of different areas of the brain. On the other hand, a 'hidden' causes of unconsciousness have to be considered, as a consequence of unconsciousness, that can give rise to a "cause paradoxical paralysis".

Anonymous Patient Answer

What are common treatments for unconsciousness?

Unconsciousness is treated with sedative drugs. As discussed elsewhere, anesthetic drugs may cause amnesia, and other drugs may reduce consciousness like the atipamezole (brand name Ativan) or naloxone (trade names Vivactil and Narcan).

Anonymous Patient Answer

Can unconsciousness be cured?

Can unconsciousness be cured? I now answer the question 'no'. Consciousness is not an intrinsic quality in living beings but depends on the function of the central nervous system.

Anonymous Patient Answer

Has islet cell transplant proven to be more effective than a placebo?

Recent findings of this clinical trial clearly demonstrated that islet cell transplantation proved to be more effective than placebo in achieving and maintaining glucose lowering for 12 weeks and, therefore, more effective than no treatment in achieving and maintaining fasting blood glucose.

Anonymous Patient Answer

What is the latest research for unconsciousness?

We found out that unconsciousness can be triggered by traumatic or stressful events, even if such stimuli are too brief or too remote. The research on the mechanism for the link between unconsciousness and the emotional stressor was still being clarified. There is still no definitive way to cure the unconsciousness, but it can be treated with cognitive therapy, relaxation therapy, etc.

Anonymous Patient Answer

Does unconsciousness run in families?

The data are not consistent with the existence of a genetically determined predisposition to developing unconsciousness as an endophenotype of psychiatric illness, although a significant genetic influence could not be ruled out.

Anonymous Patient Answer

What are the latest developments in islet cell transplant for therapeutic use?

Over the last 10 years, the field has transitioned from a Phase 1, uncontrolled safety test to a Phase 2, controlled safety study. Newer immunosuppressive agents are being tested as well. At the same time, an increasing number of patients are coming with islet cell disease. It is likely that future trials should incorporate all of the latest clinical practices and therapeutic modalities.

Anonymous Patient Answer

Have there been any new discoveries for treating unconsciousness?

Patients with aneurismal subarachnoid hemorrhage and cardiac arrest, both of which may lead to coma, require intensive monitoring by medical personnel during the post-resuscitation period. Neuroprotective therapy, which includes the administration of NMDA antagonists, the application of hydrogen peroxide, the application of glutathione peroxidase, and hypothermia, may be helpful to patients after recovery from unconsciousness.

Anonymous Patient Answer

What is islet cell transplant?

In a recent study, findings showed that islet cell transplant (ICT) is a useful therapeutic option in refractory nephropathy and diabetes mellitus in diabetic recipients with severe CKD and can relieve the signs of end-stage kidney disease in the short time period, the major benefit of which is the improvement in QOL; thus, when possible, it should be considered when treating severe-cystic-kidney disease and diabetic nephropathy.

Anonymous Patient Answer
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