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NCT06853522

hucMSCs Exosomes for the Treatment of Active Ulcerative Colitis

Not yet recruiting EARLY_PHASE1 Last updated 27 April 2025
What this trial tests

EARLY_PHASE1 trial testing exosomes derived from human umbilical cord mesenchymal stem cells in Ulcerative Colitis (UC) in 40 participants. Not yet recruiting.

Timeline
30 May 2025
Primary endpoint
4 April 2027
4 April 2028

Quick facts

Lead sponsorShanghai East Hospital
PhaseEARLY_PHASE1
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment40
Start date30 May 2025
Primary completion4 April 2027
Estimated completion4 April 2028
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Shanghai East Hospital

Who can join

Adults 18 to 75, any sex, with Ulcerative Colitis (UC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To evaluate the safety and efficacy of hUC-MSCs-Exos in the treatment of ulcerative colitis.

Publications & conference data

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

  1. Exosome-Based Drug Delivery: A Next-Generation Platform for Cancer, Infection, Neurological and Immunological Diseases, Gene Therapy and Regenerative Medicine.
    Serrano DR, Juste F, Anaya BJ, Ramirez BI, et al · · 2025 · cited 27× · PMID 41155971 · DOI 10.3390/pharmaceutics17101336
  2. Biological Nanotherapeutics Derived From Human Umbilical Cord Mesenchymal Stem Cells: Mechanisms and Translational Potential in Multisystem Therapies for Regeneration and Oncology.
    Zhang R, Xu Z, Xu S, Li R, et al · · 2025 · cited 3× · PMID 41078403 · DOI 10.2147/ijn.s550390
  3. Stem Cell Therapies for Gastrointestinal and Liver Diseases: Translational Barriers, Clinical Heterogeneity, and Future Directions.
    Nikolaev G, Lozenov S, Konaktchieva M, Arabadzhiev B, et al · · 2026 · PMID 42193425 · DOI 10.3390/biomedicines14051102
  4. The roles and clinical applications of mesenchymal stem cells and their exosomes in hematologic diseases.
    Deng M, Zhang X, Zhang Y. · · 2025 · PMID 41444972 · DOI 10.1186/s13287-025-04880-8
  5. Endoplasmic reticulum stress and exosomes secretion in the pathogenesis of inflammatory bowel disease: a concise summary of research findings.
    Shibili P A, Banerjee A, Chakraborty S, Kondaveeti SB, et al · · 2025 · PMID 41383462 · DOI 10.3389/fphar.2025.1702825

Verify or expand the search:

Other recruiting trials for Ulcerative Colitis (UC)

Currently open trials in the same condition.

Other Shanghai East Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing