RECRUITING

Cellular Therapy for Type 1 Diabetes Using Mesenchymal Stem Cells

Conditions

Diabetes Mellitus, Type 1 mesenchymal stem cells diabetes autoantibodies C-peptide Type 1 diabetes mellitus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to determine the safety and efficacy of fresh metabolically active allogeneic umbilical cord-derived mesenchymal stromal cells (UC-MSCs) for the treatment of new-onset type 1 diabetes (T1D) and to understand the mechanisms of protection. If proven effective, such a strategy can be used as a therapeutic option for T1D patients and potentially other autoimmune disorders.

Official Title

Cellular Therapy for Type 1 Diabetes Using Mesenchymal Stem Cells

Quick Facts

Study Start:2020-02-27

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04061746

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 30 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* A new diagnosis of T1D based on the ADA criteria within 6 months of randomization. * Male and female between the ages of 18 and 30 * Mentally stable and able to comply with the procedures of the study protocol * Positivity for at least one T1D-associated autoantibody, such as GAD, IA-2 or ZnT8 autoantibodies * At screening, patients must have residual β cell function with a stimulated peak C-peptide \>0.2 nmol/l during a 2 hour MMTT * Must be willing to comply with "intensive diabetes management" (\* See diabetes management at MUSC below) as directed by the participant's clinician with the goal of maintaining blood glucose as close to normal as possible * Subject must be willing to comply with the schedule of study visits and protocol requirements * Subject with normal laboratory values of: White blood cell counts: between 4,500 to 11,000 per microliter; Platelet counts: 140,000 to 450,000 platelets per microliter of blood; Serum creatinine range is 0.6-1.3 mg/dL, Hepatic function: ALT 5 to 55 units per liter (U/L), AST 5 to 48 U/L.	* Evidence of retinopathy at baseline based on ophthalmologic examination or medical record review. * Body Mass Index \< 14 or \>35 * Presence of malignancy * Subject has abnormally high lipid levels that exceeds \> 3 times the upper limit of normal for LDL cholesterol or triglycerides * Subject has blood pressure greater than 160 mmHg systolic or 100 mmHg diastolic at time of consent * Subject is being treated for severe active infection of any type * A female subject who is breast-feeding, pregnant, or intends to become pregnant during the study. * Subject with clinically relevant uncontrolled medical condition not associated with diabetes (e.g. severe psychiatric, hematologic, renal, hepatic, neurologic, cardiac, or respiratory disorder) * Subjects with HgbA1c \>12%, and/or fasting blood glucose \>270 mg/dL and/or frequent episodes of hypoglycemia (\>2 episodes per week of blood glucose levels \<60 mg/dL).

Inclusion Criteria

Exclusion Criteria

* A new diagnosis of T1D based on the ADA criteria within 6 months of randomization.
* Male and female between the ages of 18 and 30
* Mentally stable and able to comply with the procedures of the study protocol
* Positivity for at least one T1D-associated autoantibody, such as GAD, IA-2 or ZnT8 autoantibodies
* At screening, patients must have residual β cell function with a stimulated peak C-peptide \>0.2 nmol/l during a 2 hour MMTT
* Must be willing to comply with "intensive diabetes management" (\* See diabetes management at MUSC below) as directed by the participant's clinician with the goal of maintaining blood glucose as close to normal as possible
* Subject must be willing to comply with the schedule of study visits and protocol requirements
* Subject with normal laboratory values of: White blood cell counts: between 4,500 to 11,000 per microliter; Platelet counts: 140,000 to 450,000 platelets per microliter of blood; Serum creatinine range is 0.6-1.3 mg/dL, Hepatic function: ALT 5 to 55 units per liter (U/L), AST 5 to 48 U/L.

* Evidence of retinopathy at baseline based on ophthalmologic examination or medical record review.
* Body Mass Index \< 14 or \>35
* Presence of malignancy
* Subject has abnormally high lipid levels that exceeds \> 3 times the upper limit of normal for LDL cholesterol or triglycerides
* Subject has blood pressure greater than 160 mmHg systolic or 100 mmHg diastolic at time of consent
* Subject is being treated for severe active infection of any type
* A female subject who is breast-feeding, pregnant, or intends to become pregnant during the study.
* Subject with clinically relevant uncontrolled medical condition not associated with diabetes (e.g. severe psychiatric, hematologic, renal, hepatic, neurologic, cardiac, or respiratory disorder)
* Subjects with HgbA1c \>12%, and/or fasting blood glucose \>270 mg/dL and/or frequent episodes of hypoglycemia (\>2 episodes per week of blood glucose levels \<60 mg/dL).

Contacts and Locations

Study Contact

Leah Benn, MPH

CONTACT

843-792-2813

bennle@musc.edu

Principal Investigator

Hongjun Wang, PhD

PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

Hongjun Wang, PhD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-27

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2020-02-27

Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

mesenchymal stem cells
diabetes
autoantibodies
C-peptide
Type 1 diabetes mellitus

Additional Relevant MeSH Terms

Diabetes Mellitus, Type 1