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Stem Cell Therapy
Stem Cell Educator Therapy for Type 1 Diabetes
Phase 1
Waitlist Available
Led By Michelle Donato, MD
Research Sponsored by Hackensack Meridian Health
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 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if a stem cell therapy is safe and effective for treating Type 1 Diabetes.
Eligible Conditions
- Type 1 Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Treatment Related Adverse Events
Secondary study objectives
Number of Patients Unable to Complete Therapy
Side effects data
From 2024 Phase 1 trial • 13 Patients • NCT0262480438%
Paresthesia
25%
Headache
25%
Hypoglycemia
25%
Dizziness
13%
Depression
13%
Infection Strep Throat
13%
Body Aches
13%
Presyncope
13%
Chest Pain
13%
Abdominal Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stem Cell Educator Therapy
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Stem Cell Educator TherapyExperimental Treatment1 Intervention
Patients will have apheresis performed and then have their own blood returned to them with the "educated" lymphocytes
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stem Cell Educator Therapy
2017
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Hackensack Meridian HealthLead Sponsor
135 Previous Clinical Trials
30,322 Total Patients Enrolled
Michelle Donato, MDPrincipal InvestigatorHackensack Meridian Health
1 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are 18 years old or older.Your liver enzymes are more than x times the normal limit.You have taken drugs that weaken your immune system within the last month. This includes medications like prednisone, cyclosporine, tacrolimus, sirolimus, and chemotherapy.Your hemoglobin level is less than 10 g/dl or your platelet count is less than 100 k/ml.You have been diagnosed with type 1 diabetes using the guidelines from the American Diabetes Association.You need to have a blood test showing that you have certain antibodies related to pancreatic islet cells.Your creatinine level is higher than 2.0 mg/dl.You have a current, ongoing infection.You are taking blood thinners other than aspirin.Your fasting C-peptide level is higher than 0.3 ng/ml.You have suitable veins for apheresis (a medical procedure to collect blood components).You have other autoimmune diseases like lupus, rheumatoid arthritis, or scleroderma.You have a heart condition or signs of heart disease on an EKG, unless a heart doctor gives approval for participation.
Research Study Groups:
This trial has the following groups:- Group 1: Stem Cell Educator 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: NCT02624804 — Phase 1
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