drugset / Trial / NCT05595681

Effect of Mesenchymal Stem Cells on Healing of Foot Ulcers in Diabetes Patients.

NCT05595681 ↗

Phase 1 Terminated 21 enrolled Cell to Cure ApS
RandomizedParallel-groupOpen-labelTreatment

Summary

The STEMFOOT Pilot Study is a single center randomized open phase I clinical intervention pilot trial with the aim of investigating the treatment effect of an allogenic adipose-derived mesenchymal stromal cell product (C2C\_ASC) compared to conventional optimal treatment on healing and complications of foot ulcers in diabetes patients.

Timeline

Start
2022-12-15
Primary completion
2025-11-28
Completion
2025-11-28

Outcome

Outcome not reported

Stopped (Enrollment): “Difficulties in enrolling trial subjects within in- and exclusion criteria, despite the trial period having been extended several times.”

Drugs

EvaluationDrugModalityDoseRoute
Subject C2C\_ASC Cell therapy 2e+07 cells Subcutaneous

Indications