CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Clusters of adipose-derived mesenchymal stem cells (Dose: 1 x 10^7 cells/1 mL/vial) +1 morebiological
Likely dose
Clusters of adipose-derived mesenchymal stem cells (Dose: 1 x 10^7 cells/1 mL/vial)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04661644
NCT04661644Phase 2Completed
CompareCT.gov

A Phase 1/2a Clinical Trial to Evaluate the Efficacy and Safety of Allogenic Adipose Tissue-derived Mesenchymal Stem Cell Clusters in Patients with Critical Limb Ischemia

S.Biomedics Co., Ltd.·interventional·Posted Dec 10, 2020·Updated Aug 30, 2024

In Brief

A Phase 2 clinical trial evaluating Clusters of adipose-derived mesenchymal stem cells (Dose: 1 x 10^7 cells/1 mL/vial) and Clusters of adipose-derived mesenchymal stem cells (Dose: 1 x 10^8 cells/1 mL/vial) for Critical Limb Ischemia. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This clinical trial is designed as a Phase 1/2a clinical trial targeting patients with critical limb ischemia. The trial is composed of Phase 1 to assess the tolerability and safety and Phase 2a to assess the safety and efficacy of the investigational product(A cluster of adipose-derived mesenchymal stem cells (3D-A) (cluster of adipose- derived mesenchymal stem cells)) and proceeds in that order.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCritical Limb Ischemia
CountriesSouth Korea
CollaboratorsDt&Sanomedics

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedDec 10, 2020
Enrollment StartNov 4, 2020
Primary CompletionApr 22, 2024
Study CompletionJul 1, 2024
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 5.6 years ago

Interventions

Clusters of adipose-derived mesenchymal stem cells (Dose: 1 x 10^7 cells/1 mL/vial)biological

Dose: 1 x 10\^7 cells/1 mL/vial (1,000 clusters of adipose-derived mesenchymal stem cells)

Clusters of adipose-derived mesenchymal stem cells (Dose: 1 x 10^8 cells/1 mL/vial)biological

Dose: 1 x 10\^8 cells/1 mL/vial (10,000 clusters of adipose-derived mesenchymal stem cells)