NCT06853522

hucMSCs Exosomes for the Treatment of Active Ulcerative Colitis

A Randomized, Single-blind Clinical Study of Human Umbilical Cord Mesenchymal Stem Cell Exosomes for the Treatment of Moderate-to-severe Active Ulcerative Colitis After Existing Therapy Failure

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shanghai East Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

A large number of previous studies and literature data collection have demonstrated the efficacy of hUC-MSCs-Exos in animal models of inflammatory bowel disease, so the investigators will further verify the safety and effectiveness of hUC-MSCs-Exos in the treatment of UC patients, and provide new ideas for clinical treatment of UC.

Conditions

• Ulcerative Colitis (UC)

Interventions

Type	Name	Description
DRUG	exosomes derived from human umbilical cord mesenchymal stem cells	The corresponding exosome content of 60×10\^6 umbilical cord mesenchymal stem cells was given
DRUG	saline +5% albumin	Equal amount of saline +5% albumin was given

Timeline

• Start date: 2025-05-30
• Primary completion: 2027-04-04
• Completion: 2028-04-04
• First posted: 2025-03-03
• Last updated: 2025-04-27

Locations

1 site across 1 country: China