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Stem Cell Therapy
Stem Cell Educator Therapy for Type 1 Diabetes
Phase 2 & 3
Recruiting
Research Sponsored by Throne Biotechnologies Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate venous access for apheresis
Must have a diagnosis of type 1 diabetes mellitus based on the 2015 American Diabetes Association criteria for the Clarification and Diagnosis of diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month
Awards & highlights
Study Summary
This trial uses a patient's own immune cells that are "educated" by cord blood stem cells in order to improveC-peptide levels, reduce median glycated hemoglobin A1C (HbA1C) values, and decrease median daily usage of insulin in Type 1 diabetes (T1D) patients.
Who is the study for?
This trial is for adults and children over 14 with Type 1 Diabetes, diagnosed within the last two years. Participants must have a certain level of C-peptide, use continuous glucose monitoring, consent to study requirements including birth control for women, and not be on immunosuppressants or have other autoimmune diseases.Check my eligibility
What is being tested?
Stem Cell Educator therapy is being tested in this trial. It involves circulating a patient's blood through a device where immune cells are 'educated' by cord blood stem cells to potentially reverse autoimmunity in Type 1 Diabetes patients.See study design
What are the potential side effects?
Specific side effects are not listed but may include discomfort from venous access for apheresis (blood processing), potential reactions related to immune modulation, and typical risks associated with blood handling.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My veins are suitable for apheresis.
Select...
I have been diagnosed with type 1 diabetes according to the 2015 ADA criteria.
Select...
My blood test shows I have antibodies against pancreatic cells.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment Adverse Events in T1D Subjects
Secondary outcome measures
Efficacy of SCE therapy in immune modulation
Preliminary efficacy of SCE therapy to improve beta cell function
Preliminary efficacy of SCE therapy to improve glucose control
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Treatment of T1D with Stem Cell Educator therapyExperimental Treatment1 Intervention
Recruited T1D subjects will receive one treatment with SCE therapy.
Group II: Conventional insulin therapyExperimental Treatment1 Intervention
Control group will receive conventional insulin therapy.
Find a Location
Who is running the clinical trial?
Hackensack Meridian HealthOTHER
131 Previous Clinical Trials
28,194 Total Patients Enrolled
Throne Biotechnologies Inc.Lead Sponsor
6 Previous Clinical Trials
290 Total Patients Enrolled
YONG ZHAO, MD,PhDStudy ChairThrone Biotechnologies Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your liver enzymes (AST or ALT) are higher than a certain limit.I am on a blood thinner that is not aspirin.You are pregnant or breastfeeding.Your creatinine level is higher than 2.0 mg/dl.You have any other autoimmune diseases, like lupus or rheumatoid arthritis.I am willing to use birth control as recommended until 6 months after treatment ends.I haven't taken any immunosuppressive drugs in the last month.Your C-peptide level is higher than 0.3 ng/ml when you haven't eaten.I am 14 years old or older.My veins are suitable for apheresis.I have heart disease or an EKG that suggests heart disease but have been cleared by a cardiologist.You need to have a continuous glucose monitoring system.I have been diagnosed with type 1 diabetes according to the 2015 ADA criteria.Your HbA1C level is less than 10% when you join the study.My blood test shows I have antibodies against pancreatic cells.Your hemoglobin is less than 10 grams per deciliter or your platelet count is less than 100 thousand per microliter.Your bilirubin levels are higher than normal.I was diagnosed within the last two years.I do not have active infections like Hepatitis B, C, or HIV.I cannot or do not want to give permission for treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment of T1D with Stem Cell Educator therapy
- Group 2: Conventional insulin therapy
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: NCT04011020 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new patients being accepted for this clinical trial currently?
"Based on the information available from clinicaltrials.gov, this research is currently recruiting patients. The study was first announced on 9/20/2022 and updated as recently as yesterday (9/19/2022)."
Answered by AI
How many people are enrolled in this experiment at most?
"That is accurate. According to the information available on clinicaltrials.gov, this study was posted on 9/20/2022 and is currently seeking candidates for participation. They are looking for 50 individuals across 1 site."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
Florida
Other
New York
How old are they?
< 18
18 - 65
What site did they apply to?
Hackensack Meridian Health
Throne Biotechnologies
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
What questions have other patients asked about this trial?
How long will screening visits take?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I’m hoping for a cure for type 1 diabetes. I was just diagnosed and would love to help find a way to cure this once and for all.
PatientReceived no prior treatments
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