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Monoclonal Antibodies
Immunotherapy for Type 1 Diabetes
Phase 1 & 2
Waitlist Available
Research Sponsored by National Center for Research Resources (NCRR)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Primary islet allotransplant
Surgical or type 1 diabetes mellitus, complicated by signs and symptoms that persist despite intensive efforts made in close cooperation with their diabetes care team
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a new immunotherapy to improve islet transplants for type 1 diabetes.
Who is the study for?
This trial is for adults over 18 with type 1 diabetes that's hard to manage despite working closely with their doctors. It's specifically for those getting a primary islet cell transplant, which replaces the insulin-producing cells in the pancreas.Check my eligibility
What is being tested?
The study tests hOKT3gamma1 (Ala-Ala), an immunotherapy drug given shortly after an islet cell transplant. The goal is to see if it can prevent the immune system from attacking and rejecting these new cells over one year.See study design
What are the potential side effects?
As this trial involves immunotherapy, potential side effects may include allergic reactions, symptoms of cytokine release syndrome like fever or fatigue, and possibly increased risk of infections due to immune system suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am receiving a pancreas cell transplant from a donor.
Select...
I have type 1 diabetes with ongoing symptoms despite working closely with my care team.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Find a Location
Who is running the clinical trial?
National Center for Research Resources (NCRR)Lead Sponsor
537 Previous Clinical Trials
317,016 Total Patients Enrolled
29 Trials studying Diabetes Mellitus
9,163 Patients Enrolled for Diabetes Mellitus
Juvenile Diabetes Research FoundationOTHER
232 Previous Clinical Trials
141,749 Total Patients Enrolled
152 Trials studying Diabetes Mellitus
130,454 Patients Enrolled for Diabetes Mellitus
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am receiving a pancreas cell transplant from a donor.I have type 1 diabetes with ongoing symptoms despite working closely with my care team.I am 18 years old or older.
Research Study Groups:
This trial has the following groups: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do participants of this trial have to meet a particular age limitation?
"The qualifying age range for participation in this medical research is 18 to 60. Separately, there are 217 trials that accept participants below the age of consent and 917 suitable for those above 65 years old."
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