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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
Study 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Treatment related adverse events
Secondary outcome measures
Number of patients unable to complete therapy
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
Find a Location
Who is running the clinical trial?
Hackensack Meridian HealthLead Sponsor
131 Previous Clinical Trials
28,235 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any openings for participants in this research?
"According to clinicaltrials.gov, this test is no longer enrolling participants at the moment; its initial listing was posted on June 27th 2017 with a last update occurring February 4th 2022. Nevertheless, there are over 1250 other trials actively recruiting patients currently."
Answered by AI
What evidence do we have that Stem Cell Educator Therapy is a secure procedure for people to undergo?
"Our team gave Stem Cell Educator Therapy a rating of 1 due to the limited data that exists on both its efficacy and safety as this is only in Phase 1 trials."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
New York
What site did they apply to?
Hackensack University Medical Center - John Theurer Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
3+
What questions have other patients asked about this trial?
How long do screening visit will last?
PatientReceived no prior treatments
Why did patients apply to this trial?
I will like to help find a cure for type 1 diabetes. I am really interested in supporting ways to advance this field.
PatientReceived 1 prior treatment
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