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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 from implantation up to 12 months post implantation
Awards & highlights
Study Summary
This trial looks at the safety and effectiveness of VCTX211 to treat Type 1 diabetes.
Who is the study for?
This trial is for people who have had Type 1 Diabetes (T1D) for at least 5 years and are on a stable diabetes treatment plan. They can't join if they've used immunosuppressants recently, had certain organ transplants, other types of diabetes, gene therapy treatments, or frequent severe unexplained drops in blood sugar.Check my eligibility
What is being tested?
The study is testing VCTX211, a new combination product to see how safe and effective it is for treating T1D. It's an early-stage trial where everyone gets the same treatment without any placebos or comparison groups.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include immune system reactions due to the nature of autoimmune disease treatments like inflammation or allergic responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from implantation up to 12 months post implantation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from implantation up to 12 months post implantation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
C-Peptide
Incidence of adverse events with causality related to VCTX211 units, the surgical procedures and/or medical interventions required to implant and explant the VCTX211 units.
Secondary outcome measures
Insulin
Body Weight Changes
Hypoglycemia
+7 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: VCTX211 unitExperimental Treatment1 Intervention
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for autoimmune diseases often involve immune-modulating therapies that aim to reduce the abnormal immune response responsible for attacking the body's own tissues. For instance, intravenous immune globulin (IVIG) is used to modulate the immune system by providing antibodies that can neutralize harmful autoantibodies and reduce inflammation.
In the context of Type 1 Diabetes (T1D), treatments like the VCTX211 combination product may focus on enhancing insulin production or protecting pancreatic beta cells from immune-mediated destruction. These mechanisms are crucial for patients as they help in managing disease symptoms, preventing organ damage, and improving overall quality of life by restoring normal immune function and preserving essential physiological processes.
Therapy-Induced Tumor Cell Death: Friend or Foe of Immunotherapy?Graves' disease: developments in first-line antithyroid drugs in the young.Clinical characteristics of chronic idiopathic thrombocytopenia in Chinese children.
Therapy-Induced Tumor Cell Death: Friend or Foe of Immunotherapy?Graves' disease: developments in first-line antithyroid drugs in the young.Clinical characteristics of chronic idiopathic thrombocytopenia in Chinese children.
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Who is running the clinical trial?
CRISPR Therapeutics AGLead Sponsor
8 Previous Clinical Trials
852 Total Patients Enrolled
1 Trials studying Autoimmune Diseases
7 Patients Enrolled for Autoimmune Diseases
ViaCyteIndustry Sponsor
6 Previous Clinical Trials
160 Total Patients Enrolled
1 Trials studying Autoimmune Diseases
7 Patients Enrolled for Autoimmune Diseases
Sandeep Soni, MDStudy DirectorCRISPR Therapeutics
5 Previous Clinical Trials
33 Total Patients Enrolled
1 Trials studying Autoimmune Diseases
7 Patients Enrolled for Autoimmune Diseases
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had gene therapy or a gene-edited treatment before.My diabetes is not caused by Type 1 diabetes.I haven't taken immunosuppressants in the last 30 days and don't need them during the study.My diabetes treatment has been the same for the last 3 months.I've had 2 or more severe drops in blood sugar without explanation in the last 6 months.I have been diagnosed with Type 1 Diabetes for at least 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: VCTX211 unit
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.
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