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Mesenchymal Stem Cells (MSCs) for Type 1 Diabetes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Medical University of South Carolina, Charleston, SCType 1 DiabetesMesenchymal Stem Cells (MSCs) - Biological
Eligibility
18 - 30
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Type 1 Diabetes

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Medium dose of allogeneic MSC
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Interferon gamma-primed mesenchymal stromal cells (MSCs)

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Over the course of 1 year (0, 1, 3, 6, 12 months)

0 - 72 Hours
Fasting and postprandial blood glucose levels after MSC infusion
Year 1
1 year peak C-peptide after a 2-hour MMTT
12 month Change in C-peptide area under the curve after a 2-hour MMTT
Change in 24-hour insulin dose per kilogram between baseline and 1 year measurements
Month 6
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
Year 1
Change in autoantigen specific T-cell response
Change in beta cell death measurements
Change in blood T-reg number and function
Change in blood autoreactive B cell number, B cell survival, and function
Change in serum glucagon levels
Changes in basal C-peptide and hemoglobin A1c
Changes in islet autoanitbodies
Body Weight Changes
Changes in serum cytokine levels after treatment
Insulin secretion rate

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Umbilical Cord Lining Stem Cells
1
Medium dose of allogeneic MSC
1
Interferon gamma-primed mesenchymal stromal cells (MSCs)

Trial Design

2 Treatment Groups

Group A Treatment
1 of 2
Group B Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: Mesenchymal Stem Cells (MSCs) · Has Placebo Group · Phase 1

Group A Treatment
Biological
Experimental Group · 1 Intervention: Mesenchymal Stem Cells (MSCs) · Intervention Types: Biological
Group B Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo Infusion (Plasmalyte A with 0.5% human serum albumin) · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mesenchymal Stem Cells (MSCs)
2017
Completed Phase 1
~20

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: over the course of 1 year (0, 1, 3, 6, 12 months)

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
853 Previous Clinical Trials
5,390,106 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,186 Previous Clinical Trials
4,089,829 Total Patients Enrolled
Hongjun Wang, PhDPrincipal Investigator - Medical University of South Carolina
Medical University of South Carolina

Eligibility Criteria

Age 18 - 30 · All Participants · 8 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
Tennessee100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

Is there an age requirement for participants in this experiment?

"This clinical trial seeks participants aged 18-30." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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