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NCT04061746
Cellular Therapy for Type 1 Diabetes Using Mesenchymal Stem Cells
Phase 1 trial testing Mesenchymal Stem Cells (MSCs) in Diabetes Mellitus, Type 1 in 60 participants. Currently enrolling.
15 April 2026
Quick facts
| Lead sponsor | Medical University of South Carolina |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 27 February 2020 |
| Primary completion | 15 April 2026 |
| Estimated completion | 30 May 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Mesenchymal Stem Cells (MSCs) — full drug profile →
- Placebo Infusion (Plasmalyte A with 0.5% human serum albumin)
Conditions studied
- Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →
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):
-
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 -
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 -
Stem Cell-Based Clinical Trials for Diabetes Mellitus.
de Klerk E, Hebrok M. · · 2021 · cited 78× · PMID 33716982 · DOI 10.3389/fendo.2021.631463 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT04061746
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials testing the same drug.
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Other recruiting trials for Diabetes Mellitus, Type 1
Currently open trials in the same condition.
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Other Medical University of South Carolina trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04061746 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medical University of South Carolina
- Last refreshed: 3 April 2026
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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