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NCT04061746

Cellular Therapy for Type 1 Diabetes Using Mesenchymal Stem Cells

Recruiting now Phase 1 Last updated 3 April 2026
What this trial tests

Phase 1 trial testing Mesenchymal Stem Cells (MSCs) in Diabetes Mellitus, Type 1 in 60 participants. Currently enrolling.

Timeline
27 February 2020
Primary endpoint
15 April 2026
30 May 2027

Quick facts

Lead sponsorMedical University of South Carolina
PhasePhase 1
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment60
Start date27 February 2020
Primary completion15 April 2026
Estimated completion30 May 2027
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Medical University of South Carolina

Who can join

Adults 18 to 40, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Identifying the Therapeutic Significance of Mesenchymal Stem Cells.
    Mishra VK, Shih HH, Parveen F, Lenzen D, et al · · 2020 · cited 115× · PMID 32384763 · DOI 10.3390/cells9051145
  2. Cell therapies in the clinic.
    Wang LL, Janes ME, Kumbhojkar N, Kapate N, et al · · 2021 · cited 99× · PMID 34027097 · DOI 10.1002/btm2.10214
  3. Stem Cell-Based Clinical Trials for Diabetes Mellitus.
    de Klerk E, Hebrok M. · · 2021 · cited 78× · PMID 33716982 · DOI 10.3389/fendo.2021.631463
  4. Stem cells differentiation into insulin-producing cells (IPCs): recent advances and current challenges.
    Silva IBB, Kimura CH, Colantoni VP, Sogayar MC. · · 2022 · cited 53× · PMID 35840987 · DOI 10.1186/s13287-022-02977-y
  5. The Clinical Trials of Mesenchymal Stromal Cells Therapy.
    Kouchakian MR, Baghban N, Moniri SF, Baghban M, et al · · 2021 · cited 30× · PMID 34745268 · DOI 10.1155/2021/1634782
  6. Therapeutic efficacy of umbilical cord-derived stem cells for diabetes mellitus: a meta-analysis study.
    Kassem DH, Kamal MM. · · 2020 · cited 27× · PMID 33198815 · DOI 10.1186/s13287-020-01996-x
  7. Current advancements in cellular immunotherapy for autoimmune disease.
    Berry CT, Frazee CS, Herman PJ, Chen S, et al · · 2025 · cited 15× · PMID 39821376 · DOI 10.1007/s00281-024-01034-5
  8. Mesenchymal Stromal Cell-Based Products: Challenges and Clinical Therapeutic Options.
    Mello DB, Mesquita FCP, Silva Dos Santos D, Asensi KD, et al · · 2024 · cited 15× · PMID 38892249 · DOI 10.3390/ijms25116063

Verify or expand the search:

Other trials of Mesenchymal Stem Cells (MSCs)

Trials testing the same drug.

Other recruiting trials for Diabetes Mellitus, Type 1

Currently open trials in the same condition.

Other Medical University of South Carolina trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04061746.

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