deltatrials
Active Not Recruiting INTERVENTIONAL NCT04061746

Cellular Therapy for Type 1 Diabetes Using Mesenchymal Stem Cells

Sponsor: Medical University of South Carolina

Updated 16 times since 2019 Last updated: Apr 17, 2026 Started: Feb 27, 2020 Primary completion: May 30, 2027 Completion: May 30, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Diabetes Mellitus, Type 1, this trial is ongoing. The trial is conducted by Medical University of South Carolina and has accumulated 16 data snapshots since 2020. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

This study seeks to find and enroll participants between the ages of 18 to 40 with new onset Type 1 diabetes (T1D) within 6 months of the first dose of insulin. T1D is an autoimmune disease in which T cells attack and destroy insulin-secreting pancreatic β cells leading to insulin deficiency and hyperglycemia in patients. Life-long insulin therapy is the major treatment option. However, insulin therapy is not a cure and a safer and more effective therapy is needed. Mesenchymal Stromal Cells (MSCs) have emerged as a novel biopharmaceutical approach for many disorders. MSCs are a cellular product that can be derived from a patient's own body (autologous) or from a donor (allogeneic). This study will obtain MSCs from umbilical cords at the time of delivery from normal women who have been extensively screened for infectious diseases. These cells produced at the MUSC Center for Cellular therapy will be used within 3 passages after collection. Evidence from animal models and clinical trials suggests that MSC infusion suppresses autoimmune and inflammatory diseases such as T1D. One clear message from these trials is that MSCs are effective at suppressing autoimmunity and seem generally safe. This study will measure safety and efficacy of...

This study seeks to find and enroll participants between the ages of 18 to 40 with new onset Type 1 diabetes (T1D) within 6 months of the first dose of insulin. T1D is an autoimmune disease in which T cells attack and destroy insulin-secreting pancreatic β cells leading to insulin deficiency and hyperglycemia in patients. Life-long insulin therapy is the major treatment option. However, insulin therapy is not a cure and a safer and more effective therapy is needed.

Mesenchymal Stromal Cells (MSCs) have emerged as a novel biopharmaceutical approach for many disorders. MSCs are a cellular product that can be derived from a patient's own body (autologous) or from a donor (allogeneic). This study will obtain MSCs from umbilical cords at the time of delivery from normal women who have been extensively screened for infectious diseases. These cells produced at the MUSC Center for Cellular therapy will be used within 3 passages after collection.

Evidence from animal models and clinical trials suggests that MSC infusion suppresses autoimmune and inflammatory diseases such as T1D. One clear message from these trials is that MSCs are effective at suppressing autoimmunity and seem generally safe. This study will measure safety and efficacy of MSCs over the course of 1 year.

Status Flow

~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Apr 2020 · 5 months · monthly snapshot~Apr 2020 – ~Jan 2021 · 9 months · monthly snapshot~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshot~Apr 2021 – ~Jan 2022 · 9 months · monthly snapshot~Jan 2022 – ~Apr 2022 · 3 months · monthly snapshot~Apr 2022 – ~Apr 2023 · 12 months · monthly snapshot~Apr 2023 – ~Nov 2023 · 7 months · monthly snapshot~Nov 2023 – ~Jul 2024 · 8 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – ~Apr 2025 · 5 months · monthly snapshot~Apr 2025 – ~Jun 2025 · 2 months · monthly snapshot~Jun 2025 – ~Apr 2026 · 11 months · monthly snapshotApr 23, 2026 – present · 59 days · daily API

Change History

16 versions recorded
  1. Apr 23, 2026 — Present [daily]

    Active Not Recruiting

    Status: RecruitingActive Not Recruiting · Phase: PHASE1None

  2. Jun 2025 — Apr 2026 [monthly]

    Recruiting PHASE1

  3. Apr 2025 — Jun 2025 [monthly]

    Recruiting PHASE1

  4. Nov 2024 — Apr 2025 [monthly]

    Recruiting PHASE1

  5. Sep 2024 — Nov 2024 [monthly]

    Recruiting PHASE1

Show 11 earlier versions
  1. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE1

  2. Nov 2023 — Jul 2024 [monthly]

    Recruiting PHASE1

  3. Apr 2023 — Nov 2023 [monthly]

    Recruiting PHASE1

  4. Apr 2022 — Apr 2023 [monthly]

    Recruiting PHASE1

  5. Jan 2022 — Apr 2022 [monthly]

    Recruiting PHASE1

  6. Apr 2021 — Jan 2022 [monthly]

    Recruiting PHASE1

  7. Jan 2021 — Apr 2021 [monthly]

    Recruiting PHASE1

  8. Apr 2020 — Jan 2021 [monthly]

    Recruiting PHASE1

  9. Nov 2019 — Apr 2020 [monthly]

    Recruiting PHASE1

  10. Oct 2019 — Nov 2019 [monthly]

    Recruiting PHASE1

    Status: Not Yet RecruitingRecruiting

  11. Sep 2019 — Oct 2019 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Eligibility Summary

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.

Contact Information

Sponsor contact:
  • Medical University of South Carolina
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations