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Mesenchymal Stem Cells
Stem Cell Therapy for Type 1 Diabetes
Phase 1
Recruiting
Led By Hongjun Wang, PhD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Positivity for at least one T1D-associated autoantibody, such as GAD, IA-2 or ZnT8 autoantibodies
Male and female between the ages of 18 and 30
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over the course of 1 year (0, 1, 3, 6, 12 months)
Awards & highlights
Study Summary
This trial will test whether fresh, donor-derived mesenchymal stem cells can safely and effectively treat new-onset type 1 diabetes. If successful, this could provide a new therapeutic option for patients with this and other autoimmune disorders.
Who is the study for?
This trial is for individuals aged 18-30 recently diagnosed with Type 1 Diabetes, having some remaining insulin-producing cell function and positive for specific diabetes-related autoantibodies. They must be mentally stable, able to manage their diabetes intensively, and have normal blood counts and liver function. Excluded are those with severe infections, certain eye diseases, extreme body weights, high blood pressure or lipids, pregnancy or intent to become pregnant during the study.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of using umbilical cord-derived mesenchymal stem cells (UC-MSCs) compared to a placebo in treating new-onset Type 1 Diabetes. The aim is to see if these cells can help manage the disease by preserving insulin production.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include immune reactions since MSCs are involved; however this will be closely monitored as part of assessing the treatment's safety.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have antibodies linked to type 1 diabetes.
Select...
I am between 18 and 30 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ over the course of 1 year (0, 1, 3, 6, 12 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over the course of 1 year (0, 1, 3, 6, 12 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
12 month Change in C-peptide area under the curve after a 2-hour MMTT
Secondary outcome measures
1 year peak C-peptide after a 2-hour MMTT
6 Month Change in C-Peptide area under the curve after a 2-hour MMTT
6 Month peak C-peptide after a 2-hour MMTT
+1 moreOther outcome measures
Change in autoantigen specific T-cell response
Change in beta cell death measurements
Change in blood T-reg number and function
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group A TreatmentExperimental Treatment1 Intervention
2.5 x 10^6 MSC per kg will be infused intravenously on Day 1
Group II: Group B PlaceboPlacebo Group1 Intervention
Plasmalyte with 0.5% Human Serum Albumin will be infused intravenously on Day 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mesenchymal Stem Cells (MSCs)
2017
Completed Phase 2
~50
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,575 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,315,234 Total Patients Enrolled
Hongjun Wang, PhDPrincipal Investigator - Medical University of South Carolina
Medical University of South Carolina
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to follow a strict diabetes management plan.My blood sugar levels are very high or I often have very low blood sugar.Before the study starts, patients must have some remaining ability for their pancreas to produce insulin.I am currently being treated for a severe infection.You have signs of retinopathy in your eyes.Your body mass index is very low or very high.I am mentally stable and can follow the study's procedures.I have antibodies linked to type 1 diabetes.My LDL cholesterol or triglycerides are more than three times the normal limit.I do not have severe health issues unrelated to diabetes.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.Your blood and organ function tests must show normal levels within a specific range. For example, your white blood cell count should be between 4,500 and 11,000.I have been diagnosed with cancer.I was diagnosed with Type 1 Diabetes within the last 6 months.I am between 18 and 30 years old.Your blood pressure is higher than 160 over 100 when you agree to join the study.
Research Study Groups:
This trial has the following groups:- Group 1: Group A Treatment
- Group 2: Group B Placebo
Awards:
This trial has 0 awards, including: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.
Is enrollment still available for this clinical experiment?
"According to information presented on clinicaltrials.gov, this medical trial has been open for recruitment since February 13th 2020 and was recently edited on March 23rd 2022."
Answered by AI
To which individuals is this research endeavor open?
"To qualify for this research trial, applicants must have a diagnosis of diabetes and an autoimmune condition, as well as falling between 18-30 years old. The project is hoping to recruit around 60 participants."
Answered by AI
What is the estimated participant count for this medical experiment?
"Affirmative. Clinicaltrials.gov verifies that this clinical trial, which has been posted since February 13th 2020 and last updated on March 23rd 2022, is currently recruiting participants for enrollment. Sixty people are being sought to take part in the study at one location."
Answered by AI
Have the federal authorities sanctioned Mesenchymal Stem Cells (MSCs) for clinical use?
"As this is a Phase 1 study, which indicates limited evidence regarding safety and efficacy, the team at Power rated MSCs as having a score of 1."
Answered by AI
Is there an age requirement for participants in this experiment?
"This clinical trial seeks participants aged 18-30."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
What portion of applicants met pre-screening criteria?
Did not meet criteria
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